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This prospective cohort study determined the incidence and risk factors for development of postdural puncture headache (PDPH) in children after lumbar puncture (LP). Eighty-six children were enrolled. LPs were performed with use of 22-gauge spinal needles with the bevel oriented parallel to the long axis of the spine. Follow-up telephone interviews and patients' diary of symptoms were collected. Headache brought on by sitting up and relieved by lying down was defined as PDPH. Of the 80 who completed the study, six (8%) developed PDPH. Two (3%) were less than 6 years old and four (5%) were 6 to 12 years of age. Children with a history of headache following a previous LP were nine times as likely to experience PDPH. PDPH occurs not infrequently in children. A prior history of headache is a predisposing factor.

PURPOSE A minority of cancer survivors develops long-term postsurgical neuropathic pain. Based on evidence that capsaicin, the pungent ingredient in hot chili peppers, might be useful for treating neuropathic pain, we developed the present clinical trial. PATIENTS AND METHODS Ninety-nine assessable patients with postsurgical neuropathic pain were entered onto this study. After stratification, patients were to receive 8 weeks of a 0.075% capsaicin cream followed by 8 weeks of an identical-appearing placebo cream, or vice versa. A capsaicin/placebo cream was to be applied to the painful site four times daily. Treatment evaluation was performed by patient-completed weekly questionnaires. RESULTS During the first 8-week study period, the capsaicin-cream arm was associated with substantially more skin burning, skin redness, and coughing (P < .0001 for each). Nonetheless, treatment was stopped for patient refusal or toxicity just as often while patients were receiving the placebo as compared with the capsaicin. The capsaicin cream arm had substantially more pain relief (P = .01) after the first 8 weeks, with an average pain reduction of 53% versus 17%. On completion of the 16-week study period, patients were asked which treatment period was most beneficial. Of the responding patients, 60% chose the capsaicin arm, 18% chose the placebo arm, and 22% chose neither (P = .001). CONCLUSION A topical capsaicin cream decreases postsurgical neuropathic pain and, despite some toxicities, is preferred by patients over a placebo by a three-to-one margin among those expressing a preference.

This study was developed to test whether prospective dietician counseling could abrogate the unwanted weight gain seen among women receiving adjuvant chemotherapy for resected breast cancer. It was also designed to examine predictive factors for weight gain in an exploratory manner. Premenopausal women starting adjuvant chemotherapy for primary breast cancer were recruited for this trial. After appropriate stratification, they were randomized to a group which received monthly dietician counseling primarily aimed at weight maintenance versus a control group (whose attending physicians and nurses told them about possible weight gain but provided no formalized dietician counseling). One hundred and seven evaluable women were equally divided between the two protocol arms. The median weight changes 6 months after start of chemotherapy were gains of 2.0 kg in the dietician counseling group versus 3.5 kg in the control group. The median changes in average calorie consumption were reductions of 120 versus 46 cal/day on weekdays and 196 versus 20 cal/day on weekends for the counseling and control groups, respectively. Study data suggest that more weight was gained by patients with higher Quetelet's indices (p = 0.01) and patients who had been on a diet in the preceding 6 months (p = 0.02). Routine prospective dietician counseling aimed at weight maintenance appeared to produce small but statistically insignificant reductions in both calorie consumption and weight gain in this group of patients.

Sedation may be a dose-limiting side-effect of opioid therapy in some cancer patients. This study was designed to evaluate further the use of the psychostimulant, methylphenidate, an agent that has been reported to counter-act opioid-induced sedation, in patients with cancer-related pain. Patients receiving a stable dose of an opioid for cancer-related pain were recruited for this randomized, double-blind, crossover clinical trial. In addition to their regular dose of narcotics, they received 5 days of methylphenidate followed by 5 days of placebo, or vice versa. Our data did not definitively demonstrate any statistically significant benefit for methylphenidate, but did suggest that this drug could mildly decrease narcotic-induced drowsiness and could increase night-time sleep. These data, in conjunction with other published data, suggest that methylphenidate can counteract narcotic-induced daytime sedation to a limited degree.

Procedure-related pain is a significant problem for many children receiving cytotoxic chemotherapy. In an effort to lessen this toxicity, we studied the efficacy and safety of administering topical local anesthesia using EMLA cream in 47 evaluable children with cancer undergoing implanted central venous port injections. Children (< 21 years old) scheduled to undergo repeated venous access procedures were selected for study. A placebo-controlled, randomized, double-blind, crossover study design was utilized. Statistically significant decreases in pain intensity scores (P < 0.002) were recorded by both children and investigators during the use of EMLA cream as compared with placebo. There was a good correlation between pain scores recorded by both patients and health care providers using both visual analog scales and categorized pain measurement tools. The topical application of EMLA cream 5% provides highly effective superficial anesthesia, and promises to be extremely useful for pain relief during percutaneous access procedures in cancer patients.

Dear Editor, Patient-controlled analgesia (PCA) is standard care of postoperative children aged roughly 8 years and over (depending on maturity) [1], allowing patients to choose their preferred balance of analgesia and side effects [2]. Morphine sulfate is generally considered the drug of choice. Expected toxicities include a 30–70% incidence of nausea and/or vomiting [3,4], a 10–80% incidence of itching [3–5], and rarer cases of urinary retention [2,4]. Respiratory depression is serious although unusual [2]. While the spectrum of anticipated toxicities is similar, anecdotal reports indicate a lower incidence of side effects with hydromorphone when compared with morphine [6]. We performed a double-blind, randomized, controlled trial comparing the toxicity of morphine with that of equianalgesic doses of hydromorphone used for PCA in children. A sample of 96 healthy children (aged 8–21 years) hospitalized after surgery was randomized to receive either morphine or hydromorphone PCA. A morphine : hydromorphone …

PURPOSE We report on a clinical trial developed to compare four different instruments that provide overall quality-of-life (QOL) scores, ranging from a simple, one-item instrument to more detailed instruments. Two issues addressed were (1) Will QOL tools suffer from missing data when used in a community-based cooperative group setting?, and (2) Are there additional data generated by a more detailed multiitem instrument over that provided by a single-item global QOL question? MATERIALS AND METHODS A four-arm randomized trial was designed to compare four instruments that provide overall QOL scores in patients with advanced colorectal cancer. Patients and physicians completed the single-item Spitzer Uniscale (UNISCALE) at baseline and monthly. Patients were randomly assigned to complete, in addition, either the 22-item Functional Living Index-Cancer (FLIC), the five-item Spitzer QOL index (QLI), a picture-face scale (PICT), or nothing else. RESULTS A total of 128 patients were randomized. Greater than 90% complete QOL data were obtained. There was strong correlation, concordance, and criterion-related validity among all four patient-completed tools. The UNISCALE had a greater decrease over time than did the FLIC (P=.005), which suggests a greater sensitivity; the UNISCALE was similar to the QLI and the PICT in this regard. Physicians provided lower UNISCALE scores than patients. Results supported the hypothesis that QOL is prognostic for survival. CONCLUSION Patients can effectively complete QOL tools in a cooperative group setting with proper education of health care providers and patients. A simple single-item tool (UNISCALE) appears to be appropriate to obtain a measure of overall QOL.

We performed an open-label pilot study to define analgesic efficacy, acceptability, and toxicity of transdermal fentanyl in an ambulatory population of patients with cancer pain. Our 7-day study included 35 patients, all of whom had failed a trial of an opioid analgesic conventionally used for moderate pain. Patients received either a 25 micrograms/hr or 50 micrograms/hr fentanyl transdermal patch depending on prior opioid dose. Pain was measured daily utilizing visual analogue (VAS) and categorical (CAT) scales. Hours of nighttime sleep, quality of life, toxicities, and use of rescue medication were also assessed. There was a 24%-29% reduction in mean VAS and CAT pain scores as compared with the baseline and a 25% increase in mean hours of nighttime sleep. Fifty-nine percent of those patients responding (46% of all study patients) were satisfied to very satisfied with the analgesia provided by transdermal fentanyl. Six percent of all study patients were not at all satisfied with the pain relief obtained. Toxicities were similar to those seen with other opioids. No patient developed severe sedation or respiratory depression. The 25-50 micrograms/hr patch appears to be a safe starting dosage in ambulatory patients previously receiving opioids conventionally used for moderate pain.

To determine the efficacy of transdermal clonidine for alleviating post-orchiectomy hot flashes, a randomized, double-blind, crossover clinical trial was designed including 70 men with a history of prostate cancer who had undergone a medical or surgical orchiectomy and were suffering from hot flashes. The results of this study demonstrated that clonidine did not significantly decrease hot flash frequency or severity. Future research is necessary to find effective means of alleviating hot flashes in post-orchiectomy patients.

Previous literature reports have suggested that sublingually administered morphine sulfate results in an improved bioavailability of the drug when compared to orally administered morphine. To investigate this possibility further, we studied six cancer patients all of whom received 10 mg doses of morphine sulfate by intramuscular, oral and sublingual routes. Pharmacokinetic analyses failed to suggest an advantage of sublingual administration when compared with oral dosing. Bioavailability of morphine following intramuscular administration appeared superior to both oral and sublingual routes.

Neutrophilic dermatosis (Sweet syndrome) is a rare condition characterized by painful indurated cutaneous plaques infiltrated with mature neutrophils and may be accompanied by fever, granulocytosis, arthritis, and conjunctivitis. It is associated with various malignant and preneoplastic states, the most common being leukemia and myeloproliferative disorders. Its association with solid tumors is infrequent. The case described here represents, to our knowledge, the first report of Sweet syndrome in a patient with osteogenic sarcoma, a primary tumor of bone arising from mesenchymal cells.

PURPOSE To determine the efficacy of transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer. PATIENTS AND METHODS A randomized, double-blind, crossover design was used in this prospective study. Women with a history of breast cancer who were receiving tamoxifen and suffering from hot flashes were potentially eligible for this protocol study. RESULTS Clonidine did reduce hot-flash frequency to a degree that was statistically impressive (P < .0001), but clinically moderate (20% reduction from baseline). It also decreased hot-flash severity (P = .02, 10% reduction from baseline). Clonidine was related to increased mouth dryness (P < .001), constipation (P < .02), itchiness under the patch (P < .01), and drowsiness (P < .05). CONCLUSION Better means are needed to alleviate hot flashes among patients in whom estrogen therapy is contraindicated.

Five cancer patients experienced satisfactory pain relief for periods of 3-156 days using continuous transdermal delivery of the narcotic fentanyl. The patients, aged 16-68 years, had all been experiencing pain and were either unable to take oral analgesic medications or these agents were ineffective in controlling pain. Doses were adjusted to individual patient needs and varied from 75 micrograms/h to 350 micrograms/h (median = 225 micrograms/h). Plasma fentanyl levels reflected the administered dose and remained constant throughout the treatment. Transdermal delivery of narcotics provides a new option for the cancer patient unable to achieve satisfactory analgesia with oral medications.

Twenty-two courses of oral methadone were given to control moderate or severe pain in 19 children with cancer. Of these, 21 courses gave adequate pain control for periods of 5 to 267 days (median 24 days). In 16 courses, methadone was continued until death or until the pain resolved; in five remaining courses, a change to parenteral narcotics was ultimately required. Toxicity was minimal. A safe starting dose of methadone appears to be 0.1 mg/kg given every 4 hours, or the equivalent total daily dose given less frequently, with escalation as required to achieve and maintain adequate pain control.

We conducted a randomized controlled trial to determine whether intensive multi-agent adjuvant chemotherapy improves the chances of relapse-free survival in patients with nonmetastatic high-grade osteosarcoma of the extremity, as compared with concurrent controls. After undergoing definitive surgery, 36 patients were randomly assigned to adjuvant chemotherapy or to observation without adjuvant treatment. At two years the actuarial relapse-free survival was 17 percent in the control group, similar to that found in studies before 1970, and 66 percent in the adjuvant-chemotherapy group (P less than 0.001). Similar results were observed among 77 additional patients who declined to undergo randomization but who elected observation or chemotherapy. We conclude that the natural history of osteosarcoma of the extremity has remained stable over the past two decades, that adjuvant chemotherapy increases the chances of relapse-free survival of patients with high-grade osteosarcoma, and that it should be given to all such patients.

case descr ibed here, can only be detected by procedures such as the M T T cytochemica l method , which are too expens ive and t ime consuming for rout ine use. However, w h e n e v e r unexpla ined neonata l j aund ice occurs, particularly in e thnic groups such as the Greeks or Chinese in w h o m severe G-6 -PD deficiency is prevalent, identification of G-6-PD deficiency in the neonate may alert family and physic ian to the need for avoidance of potentially hemolyt ic agents during subsequen t pregnancies. The ery throcytes o f such newborn infants should, therefore , be eva lua ted routinely for the presence of G-6-PD deficiency.

We studied nine children who had received cranial irradiation for various malignancies and subsequently experienced decreased growth velocity. Their response to standard growth hormone stimulation and release tests were compared with that in seven children with classic GH deficiency and in 24 short normal control subjects. With arginine and L-dopa stimulation, six of nine patients who received radiation had a normal GH response (greater than 7 ng/ml), whereas by design none of the GH deficient and all of the normal children had a positive response. Only two of nine patients had a normal response to insulin hypoglycemia, with no significant differences in the mean maximal response of the radiation and the GH-deficient groups. Pulsatile secretion was not significantly different in the radiation and GH-deficient groups, but was different in the radiation and normal groups. All subjects in the GH-deficient and radiation groups were given human growth hormone for 1 year. Growth velocity increased in all, with no significant difference in the response of the two groups when comparing the z scores for growth velocity of each subject's bone age. We recommend a 6-month trial of hGH in children who have had cranial radiation and are in prolonged remission with a decreased growth velocity, as there is no completely reliable combination of GH stimulation or release tests to determine their response.

The incidence and nature of pain in 92 children and young adults presenting with newly diagnosed malignancy at the Pediatric Branch of the National Cancer Institute over a 26 month period were assessed. At the time of their initial evaluation, 72 of the total 92 patients were experiencing pain that had been present for a median of 74 days (range 3–821 days) prior to initiation of cancer treatment. In 57 patients, pain had been an initial symptom of cancer; 42 patients had experienced sleep disturbance due to pain. Following the institution of cancer therapy, pain persisted for a median of 10 days. One patient died of malignancy after 5 months without resolution of her pain, and only 4 had persistent pain for greater than 9 months after the start of treatment. Persistent pain is an important symptom of cancer in children and young adults and is often present for long periods before the diagnosis of malignancy is made. Cancer in children usually responds rapidly to modern therapy, and pain usually persists only briefly after the initiation of treatment.

• Forty-five episodes of Staphylococcus aureus septicemia occurred in 44 children with malignant neoplasms over a seven-year period. The most frequent findings at diagnosis were fever, neutropenia, and an active malignant process. Twenty-six (58%) of 45 episodes had a primary focus of infection. Multiple-organism sepsis occurred four times; three episodes were fatal. Only one patient with single-organism S aureus sepsis died (a mortality of 2%). Direct infectious complications occurred in nine (20%) of 45 episodes. Endocarditis and osteomyelitis were not seen as complications of S aureus sepsis. ( Am J Dis Child 134:831-833, 1980)

The child with cancer may experience pain of several causes: pain caused directly by the malignancy, treatment-related pain, procedural pain, and pain from an unrelated medical condition. Cancer-related pain most often arises from invasion of bone or bone marrow; however, invasion of the nervous system or other soft tissues also may result in pain. When definitive anticancer treatment is ineffective or unavailable, the correct use of analgesic drugs forms the mainstay of treatment for pain. Other modalities, including anesthetic and neurosurgical interventions and noninvasive techniques, also may be helpful.

The prognosis for children with osteosarcoma has improved dramatically over the past 15 years. Prior to 1970, fewer than 20% of patients with osteosarcoma treated only with surgery of the primary tumor survived 5 years (1,2), and it was inferred from the experience at multiple institutions that at least 80% of patients presenting without overt metastatic disease, in fact, had microscopic subclinical metastases at the time of diagnosis. Today, projected 5-year survivals of 60–80% are reported from a number of treatment centers. This improvement in prognosis for more recently diagnosed patients with osteosarcoma had been attributed to the administration of adjuvant chemotherapy after surgery which apparently was effective in eradicating micrometastatic disease.

Morphine plasma concentrations were determined in 19 children with cancer. A single dose of morphine, 0.09-0.15 mg/kg, was given intravenously over 3-5 min. The plasma concentrations of morphine ranged from 23 to 472 ng/ml at 10 min and from 6.1 to 20.8 ng/ml at 60 min after morphine administration. The morphine plasma concentration exceeded the reported average analgesic concentration of about 20 ng/ml in only 1 patient at 60 min and subsequently declined further except for 4 patients in whom plasma levels exhibited a secondary peak. The pharmacokinetics of morphine was studied in 6 children. The total clearance of morphine ranged from 9.03 to 53.4 ml/min/kg. The apparent volume of the central compartment and the apparent volume of distribution at steady state ranged from 0.17 to 1.10 and from 2.06 to 7.86 l/kg, respectively. The elimination half-life ranged from 0.86 to 7.55 h. These data indicate that an interindividual variation in morphine pharmacokinetics is one factor responsible for varying dosage requirements in children with cancer.

The cerebrospinal fluid (CSF) and plasma pharmacokinetics of morphine administered as a continuous infusion were studied in pediatric cancer patients and in monkeys with implanted Ommaya reservoirs. In monkeys administered a constant infusion of 0.15 mg morphine sulfate/kg/h, morphine steady-state plasma and CSF concentrations were 84.4 ±20.0 ng/ml and 25.3 ± 4.9 ng/ml, respectively, for a CSF : plasma ratio of 0.30 ± 0.05. For comparison, the monkeys also received morphine as an intravenous bolus at a dose of 0.45 mg morphine sulfate/kg. The CSF:plasma area under the concentration-time curve (AUC) ratio was 0.40 ± 0.07, similar to that seen with continuous infusion. Morphine pharmacokinetics were also studied in cancer patients administered long-term infusions of morphine sulfate over a wide dosage range (0.04–31 mg/kg/h). The steady-state plasma concentration of morphine was linearly related to the infusion rate although variability was noted. The average clearance value was 23 ml/min/kg which is at the upper end of the estimates reported for morphine clearance using bolus administration. No evidence for morphine accumulation using long-term administration was observed. A limited number of CSF samples obtained by lumbar puncture showed comparable CSF and plasma concentrations of unbound morphine assuming morphine is approximately 30% bound in human plasma.

One hundred one consecutive episodes of blood-culture-positive infec tion were evaluated in 83 children with malignancy between 1972 and 1977. Eighty-two per cent occurred in relapse, and 75% developed when the ab solute neutrophil count was less than 500 per μl. Forty per cent were fatal. Forty-five per cent of the episodes occurring in relapse and 17% occurring in remission were fatal. Of 88 cases of single-organism infection, 46% were due to gram-positive organisms with a 13% mortality (of these, 28% were due to Staphylococcus aureus with a 4% mortality); 52% were due to gram-negative organisms with a 52% mortality; and two episodes were due to fungal organ isms with no fatalities. Multiple-organism infection occurred 13 times, of which 11 episodes were fatal. The authors' data confirm observations by others that the organisms most commonly causing blood-culture-positive infection in children with malignancy are S. aureus and Escherichia coli and that infection due to gram-positive organisms, particularly S. aureus, is less frequently fatal.

• Five young adults with malignant neoplasms developed symptoms of narcotic withdrawal six to 48 hours after the abrupt discontinuation of narcotic therapy that had been administered for six to 21 days. The symptoms, which included agitation, irritability, muscular jerks, abdominal pain, diarrhea, burning sensations, "gooseflesh," and itching, rapidly resolved when narcotic therapy was reinstituted. Four patients were then successfully weaned from opiates without recurrence of their withdrawal symptoms; the fifth patient continues to receive methadone hydrochloride treatment for continuing pain. ( AJDC 1986;140:603-604)

Hemorrhage in the newborn period in infants with hemophilia is rarely seen except in those children undergoing circumcision.1 Although reported in only five infants since 1960, scalp hemorrhage in newborn infants with hemophilia may be life-threatening.2-5 We have recently seen two infants with severe hemophilia A; each had a life-threatening subgaleal hematoma in the newborn period. Consumptive coagulopathy complicated the clinical and diagnostic evaluation in one case. CASE REPORTS Case 1 K. J. was a 3,370-gm infant born at 42 weeks' gestation by a forceps delivery after a prolonged labor with oxytocin (Pitocin) augmentation. In the first hours of life, a hematoma was noted over the right parietal area.

Seventeen children with severe pain due to malignant neoplasm were successfully treated with a subcutaneous infusion of morphine sulfate using a syringe pump. Pain relief was adequate in every case without major side effects. The median dosage required was 0.06 mg/kg/hr (range, 0.025 to 1.79 mg/kg/hr). Three patients received the subcutaneous infusion at home. No patient required an intravenous line for pain control.