Search

The control of postoperative pain in the pediatric orthopaedic patient is a challenging endeavor. Several studies have shown the efficacy of ketorolac tromethamine in the pediatric general surgical population, but its efficacy in the pediatric orthopaedic population remains unproven. Twenty-seven consecutive patients (age 6 months to 18 years) who underwent long-bone osteotomies or foot procedures by a group of three pediatric orthopaedic surgeons were given a ketorolac protocol (1 mg/kg loading, 0.5 mg/kg every 6 h for 24 h). Breakthrough pain was managed with morphine until the patient was able to take oral pain medication, as was any pain after the 24-h period for ketorolac expired. Thirty-seven age- and case-matched patients were used as retrospective controls. The patients in the study who received ketorolac required significantly fewer doses of morphine than did the control group (2.29 +/- 3.98 vs. 10.02 +/- 3.39; p < 0.05). In addition the patients on the ketorolac protocol experienced fewer gastrointestinal side effects (4% vs. 32%; p < 0.05). Finally, the patients in the ketorolac group had a significantly shorter length of stay (3.63 +/- 1.64 days vs. 4.74 +/- 1.76 days; p < 0.05). There were no bleeding complications in either group. Ketorolac is thus a safe and effective means of controlling postoperative pain in the pediatric orthopaedic population while avoiding the troubling maleffects seen with the exclusive use of morphine.

Recent reports have associated an increased incidence of bleeding after tonsillectomy with the perioperative use of ketorolac tromethamine. To review this association, we examined the hospital and office records of 310 pediatric patients who underwent tonsillectomy with or without adenoidectomy at our institution during a 2-year period. Of these patients, 213 received ketorolac administered as a single dose at the conclusion of the procedure. The remaining 97 patients did not receive ketorolac. The frequency of postoperative hemorrhage was not found to differ significantly between these 2 groups (2.3% vs. 3.1% respectively, P = 0.71). Furthermore, the average time to discharge after surgery was significantly shorter in those patients who received ketorolac than in those who did not (8.5 hours vs. 12.5 hours, respectively, P < 0.0001). The frequency of overnight hospital stays was also significantly lower in those patients who received ketorolac (16.0% vs. 31.6%, respectively, P < 0.01). Concern over the potential for increased hemorrhage after tonsillectomy has led several authors to caution against the use of ketorolac in this setting. In our study, however, the use of ketorolac was not found to increase the incidence of posttonsillectomy hemorrhage and furthermore was associated with a significant decrease in the length of hospital stay as well as a decreased likelihood of overnight hospital stay after surgery.

Purpose: To investigate the efficacy and safety of nonpreserved ketorolac tromethamine 0.5% ophthalmic solution in relieving pain following radial keratotomy (RK)., Setting: Multicenter clinical trial., Methods: Topical ketorolac was compared with its vehicle in a double-masked, randomized, parallel-group study involving 170 RK patients. Patients were treated with nonpreserved ketorolac 0.5% ophthalmic solution or the vehicle 4 times daily beginning immediately after surgery and continuing for 3 days or until they no longer had ocular pain., Results: At several intervals, patients treated with ketorolac reported significantly greater pain relief and less pain intensity than patients treated with the vehicle. The time required for patients to first report "complete relief" or "no pain" was shorter in the ketorolac than in the vehicle group (P < or = .006). Patients in the ketorolac group used less escape medication (acetaminophen) (P < or = .001) and had fewer sleep difficulties (P < or = .031), fewer symptoms of ocular discomfort (P < or = .028), and less difficulty performing activities of daily living (P = .048). Patients treated with ketorolac experienced the same low rate of treatment-related adverse events as those treated with the vehicle and exhibited the same improvement in visual acuity and manifest refraction., Conclusions: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, the vehicle in alleviating the postoperative pain associated with RK. This resulted in significant improvements in patient quality of life and less need for oral analgesics, suggesting that topical ketorolac is an appropriate treatment option for ocular pain following RK.

Objective: Ketorolac tromethamine 0.5% and diclofenac sodium 0.1% ophthalmic solutions are approved for use by the U.S. Food and Drug Administration to avoid excessive postoperative inflammation after cataract surgery and implantation of an intraocular lens. This study compares the efficacy and toxicity of these nonsteroidal anti-inflammatory drugs for the first time., Design: Randomized, double-masked, prospective clinical trial., Participants: A total of 120 patients assigned in equal numbers to 1 of the 2 treatment regimens., Intervention: Treatment with either ketorolac 0.5% or diclofenac 0.1% ophthalmic solutions instilled four times daily for 30 days beginning the first postoperative day after surgery., Main Outcome Measures: Objective (Kowa FC 1000 laser cell and flare meter) and subjective (slit-lamp biomicroscope) measurements of inflammation and toxicity were made and compared at three separate post-operative visits., Results: The anti-inflammatory effects of the two treatment regimens were not statistically different at any of the postoperative visits. Patients tolerated both treatments equally well., Conclusions: This study shows diclofenac sodium 0.1% and ketorolac tromethamine 0.5% ophthalmic solutions are equally effective and safe for the control of postoperative inflammation after uncomplicated cataract surgery performed by phacoemulsification followed by the implantation of a foldable intraocular lens.

Purpose: To compare the analgesic efficacy and safety of nonpreserved ketorolac tromethamine 0.5% with those of its vehicle in the treatment of postsurgical ocular pain following radial keratotomy., Methods: This study employed a multicenter, double-masked, randomized, parallel-group design. Radial keratotomy patients were treated with either nonpreserved ketorolac tromethamine 0.5% or its vehicle four times daily for up to 3 days following surgery. Patients were provided with an escape medication (acetaminophen) for use only as needed for intolerable pain., Results: Patients treated with ketorolac reported significantly greater pain relief (P < or =.023), less pain intensity (P < or =.047), less use of escape medication (P < or =.001), fewer symptoms of ocular discomfort (P=.024), and fewer sleep disturbances (P < or =.013) than did patients treated with vehicle. No treatment-related adverse events were reported in the ketorolac group, and only one treatment-related adverse event was reported in the vehicle group. Most other safety findings were equivalent in the two treatment groups except that there were significantly less eyelid erythema (P=.026) and eyelid edema (P < or =.001) in the ketorolac group., Conclusions: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, vehicle in the treatment of postoperative pain associated with radial keratotomy. Therefore, topical ketorolac may be a valuable treatment option for the maintenance of patient comfort following refractive surgery.

Analgesia with nonsteroid antiinflammatory drugs (NSAID) becomes a pressing problem today. One such drug is ketorolak tromethamine (KT), characterized by expressed analgesic activity comparable with that of opioid analgesics morphine or promedol. Our purpose was to assess KT efficacy in analgesia performed by different methods, including analgesia controlled by the patient (ACP) after surgery. In medium severe and strong pain KT was used in group I (n = 60) "as needed" in a dose of 30 mg up to 3-4 times a day, in group 2 (n = 12) by the ACP method, in group 3 (n = 16) KT was incessantly infused in a daily dose of up to 120 mg, and in group 4 (n = 11) KT was injected 3-4 times a day in a dose of 30 mg in combination with morphine ACP. The results indicate a high efficacy of KT: 83% after a single injection. Combined use of KT and promedol decreased the dose by 40-50%. Side effects were observed in 15% of patients: most often it was a sense of fever and sweating (in 4% of patients), nausea and vomiting (in 2%), insomnia (in 2%). ACP and planned injections in a daily dose of 90-120 mg is the optimal method of analgesia in patients after extensive surgical interventions.

Objective: To compare the effects of topical 0.5% ketorolac tromethamine ophthalmic solution (Acular, Allergen Pharmaceuticals, Irvine, Calif) with topical 0.03% flurbiprofen sodium ophthalmic solution (Ocufen, Allergen Pharmaceuticals) on the inhibition of surgically induced miosis during phacoemulsification cataract surgery., Design: One hundred eighteen patients were prospectively randomized to receive 0.5% topical ketorolac or 0.03% topical flurbiprofen at 3 preoperative intervals. The flurbiprofen-treated group served as the control group. The surgeon was masked as to patient selection. Horizontal pupillary diameter measurements were obtained at the start of surgery, just before phacoemulsification, before lens implantation, and after lens implantation., Results: Mean horizontal pupillary diameter measurements for both medications were similar at the start of surgery. However, a consistent trend of larger pupillary diameter was seen in all subsequent surgical intervals in the ketorolac-treated group. Changes from baseline measurements also indicated a more significant inhibition of miosis at all subsequent intervals, and a more stable mydriasis throughout the procedure in the ketorolac-treated group., Conclusions: Topical ketorolac is an effective inhibitor of miosis during phacoemulsification cataract surgery, and provides a more stable mydriatic effect throughout the surgical procedure.

The efficacy of postoperative pain relief by ketanov and tramal was assessed in 42 patients operated on the abdominal organs and lower limb arteries. The time of development of the analgesic effect and duration and depth of analgesia were compared. The drug effects were compared from protocols of clinical examination, hemodynamic changes, and time course of external respiration and blood saturation with oxygen. The findings confirm a high analgesic effect of ketanov, which is not inferior to tramal, and by some parameters even higher.

Ketorolac tromethamine (KT) is a nonsteroidal, antiinflammatory analgesic. Its nonsedating property makes it an attractive analgesic for sleep apnea patients undergoing uvulopharyngopalatoplasty, but its antiplatelet activity makes the potential for postoperative hemorrhage a concern. A prospective, randomized, double-blind study was designed to evaluate the bleeding risk of KT using adult tonsillectomy patients as the model. Patients were randomized into two groups receiving Meperidine (MP) (controls) or KT for the first postoperative day. Posttonsillectomy bleeding rates of 7% (3/43) in the MP group and 18.9% (7/37) in the KT group were demonstrated, but this difference was not statistically significant. The number of KT doses administered had no effect on the incidence of bleeding or the number of cases requiring return to the operative suite for hemostasis. Although this study did not attain statistical significance, the trend towards increased hemorrhage with KT is worrisome. This study and other reports in the literature support the manufacturer's warning that the use of KT is contraindicated in major surgery.

Objective: To determine the occurrence of posttonsillectomy bleeding in patients who received intraoperative ketorolac tromethamine., Design: Retrospective analysis., Setting: Academic tertiary care center., Patients: Three hundred eleven patients who underwent tonsillectomy in an 18-month period., Main Outcome Measure: Occurrence of bleeding complications in patients who received ketorolac during tonsillectomy., Results: Fifty-eight of 311 patients who underwent tonsillectomy received intraoperative ketorolac with an overall postoperative bleeding rate of 17%. This high rate of bleeding complications compares with 4.4% in the remaining 253 patients who received traditional opioid analgesics., Conclusions: Until further controlled studies have been conducted, the use of ketorolac in patients undergoing tonsillectomy should be avoided because of the increased incidence of postoperative bleeding complications.

Background: Ketorolac tromethamine 0.5 percent ophthalmic solution is a widely used nonsteroidal anti-inflammatory drug (NSAID) in ophthalmology. Ketorolac eye drops have not been implicated previously as a cause of NSAID-induced asthma., Study Design: A patient with severe asthma after topical application of ketorolac is described. The current ophthalmic indications for topical application of ketorolac and reported hypersensitivity reactions with systemic use of ketorolac are reviewed., Results: A 44-year-old woman with chronic asthma, rhinosinusitis, and nasal polyps inadvertently was given ketorolac to be applied topically. After applying the first dose of ketorolac, an exacerbation of her asthma developed, necessitating hospital admission., Conclusions: Topical application of ketorolac is safe in the vast majority of ophthalmology patients. However, NSAID eye drops should not be prescribed for patients with aspirin or NSAID allergy or the combination of asthma and nasal polyps unless the patient is known to tolerate aspirin without trouble.

Ketorolac prolongs bleeding time and inhibits platelet aggregation and platelet thromboxane production in healthy, awake volunteers. However, platelet function was recently shown not to worsen after ketorolac was given during general anesthesia. The purpose of this study was to investigate platelet function changes during a standardized spinal anesthetic and surgery, as well as after a single intraoperative dose of intravenous (IV) ketorolac. The study comprised 30 ASA physical status I patients undergoing spinal anesthesia for knee arthroscopy. Subjects were randomized to receive either ketorolac 60 mg IV 15 min after skin incision or placebo IV. Platelet function testing consisted of an Ivy bleeding time, platelet aggregometry with adenosine diphosphate (ADP) and collagen, thromboelastography (TEG), and serum thromboxane B2 (TxB2) assays. Platelet function testing was performed: 1) 15 min prior to the performance of spinal anesthesia; 2) 10 min after surgical skin incision; and 3) 45 min after administration of study drug. The placebo group demonstrated no changes in any platelet function variable during spinal anesthesia and surgery relative to preoperative values. The ketorolac group, however, demonstrated a significant increase in bleeding time from postincision to poststudy drug data points (213 +/- 60s to 275 +/- 85s, mean +/- SD; P < 0.01). Further, platelet aggregometry to collagen was diminished in the ketorolac group from preoperative to poststudy drug data points (90.8% +/- 7.6% to 60.5% +/- 32.5%; P < 0.01). Platelet aggregometry with ADP, however, was unchanged in the ketorolac group. Platelet TxB2 production decreased dramatically in the ketorolac group from preoperative to poststudy drug data points (157.2 +/- 129.4 to 0.3 +/- 0.3 ng/mL; P < 0.01). Platelet function does not appear to be accentuated during spinal anesthesia as it is during general anesthesia. Unlike during general anesthesia, platelet function during spinal anesthesia is impaired, with respect to bleeding time and platelet aggregometry to collagen, by a single intraoperative dose of IV ketorolac.

Postoperative patients may receive ketorolac, a nonsteroidal antiinflammatory drug that inhibits platelet function, for analgesia and may receive low-molecular-weight heparin (LMWH) for thrombosis prevention. We investigated whether the combination of these two agents increases blood loss in a rabbit model of hemostasis. In a randomized, blinded study, animals received either intramuscular ketorolac (0.5 mg/kg or 1.0 mg/kg) and subcutaneous saline solution, subcutaneous LMWH (100 U/kg) and intramuscular saline solution, ketorolac (0.5 mg/kg or 1.0 mg/kg) and subcutaneous LMWH (100 U/kg), or intramuscular and subcutaneous saline solution given 30 minutes before ear incision and measurement of blood loss. Collagen-induced platelet aggregation was examined and anti-Xa levels were determined by using a chromogenic substrate method. As compared with results in saline-treated controls, blood loss was significantly increased in animals receiving ketorolac in a dose of 1.0 mg/kg but not in those treated with 0.5 mg/kg. The addition of LMWH did not further increase blood loss above that observed with either dose of ketorolac alone. Platelet aggregation was inhibited by both doses of ketorolac. The anti-Xa levels in the LMWH-treated animals were comparable to those measured in patients receiving these agents for prophylaxis (0.09 to 0.13 U/ml). We conclude that in the rabbit model, LMWH does not augment ketorolac-associated bleeding when both agents are used in doses comparable to those given to human patients.

Objective: To compare three analgesic regimens in patients undergoing colon resection: patient-controlled morphine sulfate analgesia (PCA), intramuscular (IM) morphine, and IM ketorolac tromethamine., Design: Prospective randomized case series., Setting: Rural, private teaching hospital., Patients: All patients (307) scheduled to undergo a major colon resection between January 1, 1992, and December 31, 1993, were eligible to participate. Of these, 10 (3%) were missed in the screening process, 132 (43%) declined participation, 73 (24%) were excluded, and 92 (30%) were enrolled and randomly assigned to a treatment group., Interventions: Ninety-two patients were enrolled in the study. Two patients never received the medication to which they were assigned, owing to administrative error; their data was not analyzed. Of the remaining patients, 31 were randomized to the PCA morphine group, 31 were randomized to the IM morphine group, and 28 were randomized to the IM ketorolac group. The randomly assigned drug was first administered in the post-anesthesia care unit. On arrival on the postoperative ward, the patient was asked to rate his or her pain using both a numerical rating scale and a visual analog scale at 30 minutes; 1, 2, 3, 4, and 6 hours after arrival on the ward; and every 4 hours throughout the first 5 postoperative days. The Mini-Mental State Examination (MMSE) was administered the day before surgery and then daily for the first 5 postoperative days. The first day the patient passed flatus after surgery was also recorded., Main Outcome Measures: The end points analyzed were adverse effects, duration of postoperative ileus, degree of pain control, length of hospitalization, and development of postoperative confusion as measured on serial MMSEs., Results: Only two patients, both in the PCA group, reported adverse effects; neither required a change in analgesia group. Significantly more patients assigned to IM ketorolac broke protocol and required alternative analgesia than did patients in the morphine groups (32% ketorolac vs 16% IM morphine and 0% PCA). The ketorolac group had a significantly shorter duration of ileus than either morphine group (P<.0l). The ketorolac group also had significantly lower pain scores (P<.04) and less postoperative confusion than the morphine groups (P<.03), although these results are limited by missing values. The ketorolac group had a significantly shorter length of stay than either morphine group (P<.01), while there was no significant difference between the morphine groups (P=.75)., Conclusions: While it appears that ketorolac provides a better postoperative course than either IM or PCA morphine in terms of pain control, postoperative confusion, length of stay, and duration of ileus, 18% of our patients assigned to ketorolac required additional analgesia, and there was a strong patient preference for PCA. Most patients should probably be managed with PCA narcotics, but the addition of ketorolac might reduce narcotic dose and resultant adverse effects. Those patients particularly prone to adverse effects should receive primarily ketorolac.

Objective: To evaluate the risk of gastrointestinal and operative site bleeding associated with the use of parenteral ketorolac tromethamine., Design: Postmarketing surveillance inception cohort study., Setting: A total of 35 hospitals throughout the Philadelphia, Pa, region, 1991 to 1993., Patients: Patients administered 10,272 courses of parenteral ketorolac therapy were compared with patients administered 10,247 courses of a parenteral opiate who were matched to the ketorolac patients by hospital, admitting service, and date of initiation of study drug., Main Outcome Measures: Medical records were reviewed for demographics, medical history, doses and duration of study drug, various aspects of the hospital course including surgery and concomitant medications, and adverse events., Results: The multivariate adjusted odds ratio (OR) comparing ketorolac with opiates for gastrointestinal bleeding was 1.30 (95% confidence interval [CI], 1.11 to 1.52); for operative site bleeding, the OR was 1.02 (95% CI, 0.95 to 1.10). The OR was elevated further in subjects 75 years of age or older for both gastrointestinal bleeding (OR = 1.66; 95% CI, 1.23 to 2.25) and operative site bleeding (OR = 1.12; 95% CI, 0.94 to 1.35). A dose-response relationship was evident between average daily ketorolac dose and both gastrointestinal bleeding and operative site bleeding (trend test P < .001 for both). When analgesic therapy lasted 5 or fewer days, ketorolac was associated with only a small increased risk of gastrointestinal bleeding (OR = 1.17; 95% CI, 0.99 to 1.30); when therapy was prolonged beyond 5 days, the OR was 2.20 (95% CI, 1.36 to 3.57). The association of ketorolac with operative site bleeding was not affected by duration of therapy., Conclusions: The overall associations between ketorolac use and both gastrointestinal bleeding and operative site bleeding are small. However, the risk associated with the drug is larger and clinically important when ketorolac is used in higher doses, in older subjects, and for more than 5 days. Improving physicians' prescribing practices by limiting the dose and duration of ketorolac use, especially in the elderly, should enhance its overall risk-benefit balance.

A double-blind, randomized, single-dose clinical trial to evaluate the analgesic efficacy of preoperative ketorolac tromethamine administration on periodontal postoperative pain was designed. One group received 20 mg ketorolac immediately before periodontal flap surgery, and the other group received placebo. Naproxen sodium was allowed postoperatively as rescue medication. The visual analog scale was used to estimate pain. Postoperative pain was assessed hourly for the first 10 h on the day of surgery, and 4 x daily on the 1st and 2nd postsurgical days. Timing and dose of rescue analgesic remedication were also recorded. Results indicated that preoperative treatment with ketorolac significantly reduced initial pain intensity and delayed the onset of postoperative pain as compared to placebo. Incidence and amount of naproxen consumption was similarly small in both ketorolac- and placebo-treated groups. No adverse reactions related to preoperative medication were observed.

Exposure of the eye to airborne particles in patients predisposed to allergy often results in the signs and symptoms of allergic conjunctivitis such as red, itchy eyes and ocular discharge. The mediators of these allergic symptoms include histamine, inflammatory substances such as prostaglandins, and other products of arachidonic acid metabolism (ie, leukotrienes). Ketorolac tromethamine is a nonsteroidal anti-inflammatory agent that inhibits the activity of cyclooxygenase, one of the two major enzymes responsible for the conversion of arachidonic acid to inflammatory substances. A multicenter patient survey was performed to evaluate the effectiveness of topical ketorolac tromethamine in treating the symptoms of allergic conjunctivitis. After ocular administration of ketorolac tromethamine, 90% (246/272) of patients reported that their eyes felt better. Eighty-four percent (173/206) of respondents rated ketorolac tromethamine as good to excellent in relieving their overall symptoms of ocular allergy, and 86% (217/251) of patients found the study drug produced good to excellent relief of their ocular itching usually within minutes to 1 hour of administration. Results of this survey found ketorolac tromethamine is effective in relieving ocular itching, the hallmark symptom of allergic conjunctivitis. In addition, these results provide further evidence that the products of arachidonic acid metabolism contribute to the symptoms of allergic conjunctivitis.

Objective: To report 3 cases of gastrointestinal (GI) complications associated with the use of intramuscular ketorolac tromethamine therapy in elderly patients., Case Summaries: In case 1, an 88-year-old woman was taken to surgery for the management of an acute abdomen and repair of a 2+ cm perforated prepyloric gastric ulcer. The patient had received a total 16 doses of ketorolac 30 mg im. The patient died after surgery from complications associated with bacterial and candidal sepsis, as well as acute renal failure. In case 2, an 80-year-old woman with no known history of GI problems developed a prepyloric gastric ulcer, which perforated and penetrated into the pancreas after the patient received 13 doses of ketorolac 30 mg im. The patient died from complications associated with candidal sepsis, peritonitis, and cardiopulmonary collapse. In case 3, an 85-year-old man with a history of a gastric ulcer developed GI bleeding after receiving a total of 9 doses of ketorolac 30 mg im. The bleeding was stabilized and the patient was discharged 12 days later in stable condition., Discussion: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug with potent analgesic properties. We report 3 cases of GI complications associated with intramuscular ketorolac therapy in the elderly. A temporal relationship was established with the development of gastric ulceration in 2 patients and the recurrence of a gastric ulcer in the third patient., Conclusions: We recommend that the manufacturer's guidelines be followed when ketorolac is used in elderly patients, and the drug should not be used in patients with a history of gastric ulcer disease. The use of misoprostol may be warranted as prophylactic therapy in high-risk patients who are receiving ketorolac.

Ketoralac is an injectable nonsteroidal antiinflammatory drug (NSAID) widely used in both out-patient and in-patient settings. Side effects such as acute renal failure, hyperkalemia, gastritis, gastrointestinal bleeding, and asthmatic exacerbation, although rare, have been previously reported. We report the case of a 20-year-old female with polyarteritis nodosa (PAN) who developed bilateral sensorineural hearing loss 25 minutes after receiving 30 mg of intravenous ketoralac. The patient denied any previous medication sensitivities, and was taking oral methotrexate and prednisone at the time of emergency department admission. Both PAN and methotrexate have been independently demonstrated to cause sensorineural hearing loss. We postulate that the patient's hearing loss was the result of ketoralac's direct and indirect ototoxic effects that were potentiated as a result of her underlying illness and medications. We recommend the cautious use of ketorolac in patients with underlying illnesses where NSAID-induced ototoxicity could result in adverse otologic consequences.

The charts of 258 patients undergoing tonsillectomy with or without adenoidectomy between June 1991 and June 1993 were reviewed. One hundred sixty-nine of these patients received ketorolac tromethamine during the perioperative period as a nonnarcotic alternative for postoperative pain management. The incidence of postoperative hemorrhage among patients who received ketorolac tromethamine was 10.1%, compared to 2.2% in those patients who received narcotic analgesia only. The average time to adequate oral intake and discharge was evaluated. Ketorolac appeared to moderately decrease the time to adequate oral intake. The use of ketorolac did not significantly alter the time to discharge. The increased incidence of postoperative hemorrhage in patients receiving ketorolac should be considered before this medication is used in the perioperative period. The risk/benefit ratio of ketorolac use as a postoperative analgesic may be better demonstrated in a prospective study.

Systemic non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to reduce alveolar bone loss in periodontitis. This study assesses the efficacy of a topical NSAID rinse, containing ketorolac tromethamine as the active agent. Adult periodontitis patients (n = 55) were studied in this 6-month randomized, double blind, parallel, placebo and positive-controlled study. Each patient had a least 3 sites at high risk for bone loss as assessed by low dose bone scan. Groups, balanced for gender, were assigned to one of three regimens: bid ketorolac rinse (0.1%) with placebo capsule; 50 mg bid flurbiprofen capsule (positive control) with placebo rinse; or bid placebo rinse and capsule. Prophylaxes were provided every 3 months. Monthly examinations assessed safety, gingival condition, and gingival crevicular fluid PGE2. Standardized radiographs were taken at baseline and at 3 and 6 months for digital subtraction radiography. A significant loss in bone height was observed during the study period in the placebo group (-0.63 +/- 0.11; P < 0.001), but not in the flurbiprofen (-0.10 +/- 0.12; P = 0.40) or ketorolac rinse (+0.20 +/- 0.11 mm; P = 0.07) groups. Nested ANOVA revealed that ketorolac and flurbiprofen groups had less bone loss (P < 0.01) and reduced gingival crevicular fluid PGE2 levels (P < 0.03) compared to placebo. ANOVA suggests (P = 0.06) that ketorolac rinse preserved more alveolar bone than systemic flurbiprofen at the dose regimens utilized. These data indicate that ketorolac rinse may be beneficial in the treatment of adult periodontitis.

Peptic ulcers, perforations, and serious gastrointestinal bleeding have not been reported with intramuscular ketoralac tromethamine, the first parenteral nonsteroidal anti-inflammatory drug available for analgesic use. This article presents the case of a 39-year-old black female who underwent surgical repair of a perforated gastric ulcer after receiving multiple dosages of intramuscular ketoralac tromethamine in the emergency room over a period of 21/2 months for the treatment of pain due to chronic pancreatitis.

The study was designed to compare intravenous ketorolac to rectal acetaminophen for analgesia and bleeding in pediatric patients undergoing tonsillectomy. We studied 50 patients, aged 2-15 yr undergoing tonsillectomy with or without adenoidectomy. In a randomized, prospective double-blind fashion, patients were assigned to receive either ketorolac (1 mg/kg) or rectal acetaminophen (35 mg/kg). Bleeding was evaluated by measuring intraoperative blood loss and noting extra measures required to obtain hemostasis. Bleeding times were also measured before and during surgery. Pain was evaluated using a standard objective pain score for the first 3 h. Persistent pain was treated with morphine, acetaminophen, and codeine and recorded for 24 h. Blood for determination of acetaminophen levels was drawn at 20 and 40 min after the administration of study drugs. Pain scores were not significantly different between the ketorolac and acetaminophen groups. The majority of patients in both groups required additional opioid in the postoperative period. Acetaminophen levels were all less than the therapeutic range. Intraoperative bleeding times were normal in all patients, but blood loss was significantly higher in the ketorolac group (2.67 mL/kg) compared to the acetaminophen group (1.44 mL/kg), P = 0.025. Significantly more measures to achieve hemostasis were required in the ketorolac group (P = 0.012). We conclude that ketorolac is no more effective than high-dose rectal acetaminophen for analgesia in the patient undergoing tonsillectomy. Hemostasis during tonsillectomy was significantly more difficult to achieve in patients receiving ketorolac.

The benefits of parenteral non-steroidal analgesic drugs and low molecular weight heparin anticoagulants have been shown before, but there is concern that the use of these agents in combination may potentiate haemorrhagic side-effects because of simultaneous inhibition of the clotting cascade and platelet mechanisms of haemostasis. In a prospective controlled trial, 60 patients undergoing total hip replacement were randomised into two groups. Those in one group received intramuscular ketorolac and those in the other group opioid analgesia. All patients received enoxaparin subcutaneously, once daily. There were 34 patients in the NSAID group and 26 in the opiate group. There were no significant differences between the two groups for intraoperative blood loss, postoperative drainage, transfusion requirements, bruising, wound oozing and leg swelling. From this study it would appear that there is a low risk of significant haemostatic potentiation associated with concurrent use of low molecular weight heparin and a modest dose of ketorolac tromethamine.

The nephrotoxic effects of nonsteroidal anti-inflammatory drugs (NSAIDs) are well recognized. Known potentiating risk factors include pre-existing renal disease, intravascular volume depletion, and concomitant administration of other nephrotoxic drugs. We present a case report of renal failure following short term usage of intramuscular ketorolac (Toradol) in a patient with no known risk factors who underwent an uncomplicated laparotomy. The literature concerning ketorolac-induced renal failure is reviewed and physicians are reminded to be aware of this potential complication.

Objective: To compare the pain relief, sedation, and common side effect profiles of ketorolac tromethamine and meperidine for the management of acute pain in the emergency department (ED)., Methods: A prospective, double-blind, randomized clinical trial was conducted over a 12-month period using consecutive adult patients presenting to a university teaching hospital ED (annual census: 32,000), who required IM analgesia for acute pain. Adult patients with acute pain of various etiologies were randomly assigned to receive a single fixed IM dose of ketorolac (60 mg) or meperidine (100 mg)., Results: Ninety-three patients were enrolled in the study; 46 were randomized to meperidine and 47 to ketorolac. Using a visual analog scale, there was no difference in pain relief between the ketorolac and meperidine groups even after adjusting for baseline pain level. Ketorolac caused significantly (p < 0.005) less sedation than did meperidine at one hour. Rescue analgesia was required for seven of the 46 (15.2%) patients receiving meperidine and five of the 47 (10.6%) patients receiving ketorolac (p = NS). Seventeen of 45 (38%) patients receiving meperidine experienced side effects compared with eight of the 47 (17%) patients receiving ketorolac (p = 0.0452)., Conclusions: When used to treat patients who had acute pain states, 60 mg of IM ketorolac produced analgesia similar to that produced by 100 mg of IM meperidine; however, the ketorolac produced fewer subjective side effects and less sedation than did the meperidine.

Ketorolac tromethamine, a potent non-narcotic prostaglandin synthetase inhibiting analgesic was compared with pethidine for relief of moderate to severe postoperative pain. Forty-eight patients received Ketorolac 0.5 mg/kg and 52 received pethidine 1.25 mg/kg. The degree of pain prior to the administration of the drug and pain relief that followed were quantified using a vertical visual analogue scale (VAS) and monitored at hourly intervals. The safety profile was also studied by recording all adverse events noted. The mean pain (VAS) score at medication for Ketorolac was 7.04 and for pethidine 7.09. The pain relief obtained in the first four hours following administration of the drugs was similar for pethidine and Ketorolac. Although Ketorolac showed a longer sustained pain relief, time to peak analgesia after administration of this drug was slower than that after pethidine. It took 30 to 50 min for pethidine compared to 75 to 150 min for Ketorolac to achieve peak analgesia. The latter is therefore inappropriate if rapid pain relief is required. The incidence of side effects was significantly greater with pethidine (40.4%) as compared to Ketorolac (10.4%). The similar analgesic efficacy to pethidine makes Ketorolac an appropriate drug for the relief of postoperative pain especially in day surgery settings where observation following administration of the drug as in the case of pethidine can be dispensed with and patients sent home earlier because of the minimal side effects associated with its use. Caution must be exercised with the use of large doses of Ketorolac especially if the drug is used for more than 5 days to avoid serious complications like renal failure and gastrointestinal bleeding.

Ketorolac tromethamine (Toradol, Syntex Laboratories Inc, Palo Alto, CA) is a new nonsteroidal anti-inflammatory drug widely used in emergency departments and during the postoperative period because of its potent analgesic effects and lack of central nervous system activities. We present three new cases of acute renal failure and hyperkalemia secondary to ketorolac. All patients had at least one risk factor making them prone to the development of acute renal failure secondary to the nonsteroidal anti-inflammatory drugs. In all patients, acute renal failure developed after a moderate dose of ketorolac was administered for the management of postsurgical pain. Acute renal failure and hyperkalemia were transient, and improved after discontinuation of ketorolac treatment.

The central effects, tolerability and pharmacokinetics of multiple intravenous doses of the analgesic ketorolac tromethamine (30 mg 4 times daily for 5 days) were studied in male volunteers. In this double-blind, randomized, parallel group study, 13 subjects received ketorolac tromethamine and 7 subjects received placebo (vehicle). To determine the effects of withdrawal all subjects were then given further dosing with placebo (4 times daily) for 2 days while maintaining the double-blind nature of the previous drug assignment. Physical examinations and laboratory tests were obtained prior to the drug administration and after completion of the study. Scales for assessment of anxiety, depression, sleep and opiate withdrawal were presented to the subjects on day 2, 5, 6, 7 and 8 of the study. After 5 days of multiple intravenous doses ketorolac showed overall good systemic tolerance and safety in comparison with placebo. Myalgia and taste perversion were more frequently reported in the ketorolac group. The frequency of injection site complaints, mostly transient pain, was about 80% for both ketorolac and placebo, indicating these were likely caused by the vehicle. There were no significant changes in the scales assessing anxiety, depression, sleep and opiate withdrawal during treatment with ketorolac and after its withdrawal, suggesting that the drug has neither any major central effects nor any clear addiction potential in this dose schedule. Pharmacokinetic parameters were derived from plasma samples collected after the first and last active doses.(ABSTRACT TRUNCATED AT 250 WORDS)

In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a non-steroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan (a combination product containing the narcotic analgesic, ketobemidone, plus a spasmolytic agent) by intramuscular injection every 1-6 h as needed for pain. When patients were able to tolerate an oral diet and were expected to respond to oral analgesic medication, based on overall pain sensitivity, they were switched to oral doses of the same medication every 4-6 h as needed. A maximum of four daily doses of medication was allowed for up to 10 days. The severity of pain was scored on a five-point scale and was recorded before the first intramuscular dose, at fixed time points thereafter for up to 6 h and at the end of each day. Both treatments were effective immediately after the first dose and during the subsequent multiple-dose phase. There were no statistically significant differences between ketorolac and Ketogan. The results show that 10-mg doses of ketorolac in intramuscular injections followed by 10-mg doses of oral ketorolac are as effective as Ketogan for the treatment of pain following orthopaedic surgery. Ketorolac appears to be better tolerated than Ketogan since significantly fewer patients reported adverse events (P = 0.004) when taking ketorolac.

Twenty one patients with sickle cell disease admitted to the hospital with the pain of vaso-occlusive crisis (VOC) were treated by continuous IV infusion of ketorolac or normal saline for up to 5 days. All patients received supplemental IM injections of meperidine, 100 mg, as necessary, but not more frequently than every 3 hr. Over the 5 days the ketorolac treated patients (KT) required 33% less meperidine than did the placebo treated patients (PL), P = 0.04, and had significantly better pain relief as assessed by categorical, visual analog, and pain relief scales. By the end of 5 days infusions had been discontinued in six KT and one PL. The time to discontinuation of the infusion was significantly shorter in KT, (P = 0.009). The median duration of hospital stay from the start of treatment was 3.3 days for KT and 7.2 days for PL, P = 0.027. Adverse events were mainly related to the digestive system. This study showed that continuous infusion of ketorolac significantly reduced total meperidine requirement and that the analgesia produced by this combination was superior to that produced by meperidine alone. Further evaluation of this drug in the management of sickle cell VOC is warranted.

In a randomized single-blind study carried out simultaneously in five Departments for Pain Therapy and Palliative Care, the analgesic efficacy and side effects of oral ketorolac (ketorolac tromethamine, Tora-Dol, CAS 74103-07-4) and diclofenac sodium were compared in a population of 100 advanced cancer patients suffering from somatic and/or visceral pain. The treatment was carried out in agreement with the first step of the WHO pharmacological strategy in cancer pain. The administered dosage was 10 mg every 6 h for ketorolac and 50 mg every 8 h for diclofenac sodium. The study showed the efficacy of both drugs in cancer pain. A greater number of keterolac patients could pass to the second WHO step later than diclofenac patients. As to the tolerability, both drugs turned out to be similar, except for "sleepiness", which was four times more frequent (p < 0.05) in the diclofenac group.

Ketorolac tromethamine (Toradol) is a nonsteroidal antiinflammatory drug (NSAID) available in intramuscular (IM) and oral formulations for the management of acute pain. Intramuscular ketorolac is the only parenteral NSAID available for analgesic use in the US. The clinical profile is reviewed, and clinical studies most applicable to a postoperative patient are discussed in detail. The results of a clinical study performed at Emory University School of Medicine are presented. In this single-dose study, 176 patients received either 10 mg of oral ketorolac, 5 mg or 10 mg of IM morphine, or placebo after orthopedic surgery. The analgesic efficacy of ketorolac was comparable to both doses of morphine and significantly superior to placebo. Ketorolac, when administered intramuscularly or orally, is a safe and effective analgesic agent for the short-term management of acute postoperative pain and can be used as an alternative to opioid therapy.

A patient, in her mid-twenties, presented with "severe polypoid sinusitis" for sphenoethmoidectomy under general anesthesia. Upon preoperative medical evaluation, it was discovered that she was "allergic" to aspirin and suffered from stress-induced asthma. Before induction of anesthesia, the patient was administered intravenous hydrocortisone and two puffs of her albuterol inhaler to prevent a possible bronchospasm due to stress of the surgery or irritation from the endotracheal tube or other stimuli. The patient was maintained throughout the case with an inhalation anesthetic for its bronchodilatory effect. The surgery proceeded unremarkably, and the patient was then administered ketorolac tromethamine for postoperative pain. After an awake extubation, the patient was transferred to the postanesthesia care unit (PACU) for further monitoring. After 15 min in the PACU, the patient claimed having difficulty breathing. She was then administered terbutaline to produce bronchodilation, but her condition did not improve. Shortly thereafter, aminophylline, midazolam, and methylprednisolone were also administered intravenously. Meanwhile, the patient had to be reintubated and placed on ventilator support with heavy sedation. At this point, it was discovered that ketorolac may have been the cause of this response. Although the patient's condition began to improve, the histamine H1- and H2-receptor blockers diphenhydramine and ranitidine were coadministered. When the patient's condition returned toward normal, she was extubated. The patient's breathing continued to improve. Thereafter, she was transferred to an overnight observation bed and later dismissed to return home. The patient was advised of the episode and warned against future intake of other nonsteroidal antiinflammatory drugs.

Acute and chronic impairment of renal function have been reported as complications of therapy with nonsteroidal anti-inflammatory agents. Renal prostaglandins play an increasingly important role in maintaining renal function when there is decreased renal blood perfusion. We describe a case of rapidly appearing acute renal failure following a single intramuscular dose of ketorolac.

We conducted a double-blind study in 34 patients to compare the analgesic efficacy in acute renal colic using 2.5 g dipyrone combined with a spasmolytic agent and 30 mg ketorolac tromethamine, diluted in 100 ml saline solution and injected intravenously. Clinical criteria and the observation of red cells in urine were used for the diagnosis. The intensity of the pain and its development were measured using visual analogue scales (VAS) and a scale of items showing patient improvement. The side effects were spontaneously mentioned by the patients and elicited by direct questioning. It can be confirmed with a beta error of 0.10 that the analgesic effect obtained by both treatments is similar. Nevertheless, the combination of dipyrone and spasmolytic produces more side effects, possibly due to the spasmolytic agent.

Objective: To evaluate reports of renal toxicity associated with intramuscular ketorolac tromethamine. Medical charts were reviewed for all cases of renal toxicity associated with ketorolac therapy., Methods: Patients with possible ketorolac-associated nephrotoxicity were identified through our institution's adverse drug reaction reporting program. Patients were included in this report if: (1) renal insufficiency was temporally related to ketorolac administration; (2) resolution of renal insufficiency occurred after discontinuation of ketorolac; and (3) no other causes of renal insufficiency, including other medications, could be identified., Results: Six patients had renal insufficiency secondary to ketorolac administration. The mean age of the patients was 58 years and cardiovascular disease was present in five. Serum creatinine values increased from a mean of 106 +/- 26 mumol/L (1.2 +/- 0.3 mg/dL) to a mean peak value of 256 +/- 195 mumol/L (2.9 +/- 2.2 mg/dL). Recovery of renal function was observed after a mean of 2.3 +/- 0.5 days., Conclusions: Short-term administration of ketorolac can be associated with reversible oliguric renal insufficiency. Indiscriminate use of ketorolac for pain management in place of narcotic analgesics should be avoided, especially in patients at high risk for toxicity induced by nonsteroidal antiinflammatory drugs.