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Needleless injection or jet injection of medication has had a rather limited clinical use in children's healthcare beyond mass vaccinations. Medications injected into children with a needle-free system include local anesthetic agents, sedatives (midazolam), and anesthetic induction agents (ketamine). Reports suggest that local discomfort is often negligible and costs are often minimal. Risks associated with this simple and flexible technique are considered to be markedly less than alternative approaches, such as syringe and needle. Further investigations are needed to confirm initial reports and establish current and other uses of jet injectors in children.

Most dentists are aware that local anesthetic injections produce the highest incidence of disruptive behavior in children. Both psychological and physiological monitoring of the response of children to dental injection, support empirical observations of clinicians. The needle-free injector delivers local anesthesia without the use of a needle. This is accomplished by delivering the anesthetic solution under high compressive forces. One hundred children between the ages of 3 to 13 years underwent operative procedures using Madajet XL. There was a statistically significant difference in favor of the instrument. The instrument was completely successful in providing anesthesia.

Medi-Ject Corporation (now Antares Pharma, Inc.) has been providing delivery devices for the needle-free administration of insulin for over 25 years. This study was one of the final steps in the development and premarket evaluation of Medi-Ject's newest needle-free system, the Medi-Jector Vision. This study was conducted to evaluate the performance of this device in the hands of experienced jet injection users in a home environment. Diabetic subjects currently using a needle-free device for the administration of their insulin were studied. Subjects used the new Medi-Jector Vision for all of their insulin administration during the course of the study. Insulin was injected on schedule and at doses consistent with their standard of practice as directed by their health care provider. All subjects were required to document each injection in a daily diary. Study subjects utilized all common insulin types (rapid, regular, intermediate, and long acting), and injections were administered in all of the common injection sites (arms, thighs, abdomen, and buttocks). Once subjects optimized the system to the most appropriate orifice size based on completeness of injection, average completeness percentages were greater than 94% for all orifice sizes. Most patients using the new Medi-Jector Vision in the home were able to manage their insulin therapy without significant complication. We conclude that the jet delivery of insulin with the new Medi-Jector Vision is well accepted by people with diabetes and offers a reliable alternative to the use of needles.

Background and Objective: There are several problems inherent in the treatment of cerebral embolisms, such as the narrow therapeutic time window and the severe side effects of fibrinolytic drugs. There is thus need of a new method of removing a cerebral thrombus more rapidly using smaller amounts of fibrinolytics., Study Design/materials and Methods: The liquid-jet generator was made by insertion of an optical fiber (diameter: 0.6 mm) into a balloon catheter (6 Fr). A pulsed holmium (Ho) YAG laser (pulse duration time = 350 micros) was used as a laser source. The maximum penetration depth of a liquid jet generated with this device into a gelatin artificial thrombus was measured at various stand-off distances (L; distance between the optical fiber end and the catheter exit). Based on the result, a stand-off distance of 13 mm was chosen to investigate the enhancement of urokinase (UK) efficacy by only a single operation of the liquid-jet device in artificial thrombi made of human blood., Results: Maximum penetration depth increased in proportion to L and reached a maximum value (9 mm) when L was around 13 mm. Fibrinolysis rates (%) after incubation with a small amount of UK for 10 and 30 minutes were predominantly raised by a single use of the laser-induced liquid jet (5.4 +/- 2.4 vs. 22.6 +/- 6.1 and 7.3 +/- 3.8 vs. 38.3 +/- 5.6, respectively (mean +/- SD, P < 0.001))., Conclusions: A laser-induced liquid jet effectively promoted fibrinolysis in vitro with use of only a small amount of fibrinolytics., (Copyright 2001 Wiley-Liss, Inc.)

Given daily, low molecular weight (LMW) heparins are established for prophylaxis against deep vein thrombosis (DVT). We describe delivery by a novel, needle-less device that is virtually painless in action. Its use could provide benefits for patients in terms of comfort both psychologically and physically, and for healthcare workers in terms of safety from needle-stick injury. Patients undergoing elective surgery received LMW heparin delivered subcutaneously by either a standard needle and syringe or by the needle-less injection device, J-Tip. Pain was scored at the time of injection and plasma anti-factor Xa levels compared between the two methods of drug delivery 4 h later: 29 patients received LMW heparin delivered by the J-Tip and 31 patients by standard needle and syringe. The J-Tip was significantly more comfortable for the patient as the method of drug delivery (P < 0.001). When delivered by the J-Tip, LMW heparin was equally as efficacious, as plasma anti-factor Xa levels were similar for both methods of delivery (P < 0.42). In summary, delivery of LMW heparin by the J-Tip device was both comfortable and effective. These findings, taken in conjunction with its ease of use and complete freedom from risk of needle-stick injury might encourage further examination and use of this type of product.

We evaluated a single-use, disposable, carbon-dioxide-powered, needleless injector (J-Tip, National Medical Products Inc., CA, USA), which is claimed to deliver a virtually painless, subcutaneous injection. Seventy-two patients undergoing various types of surgery had a large-bore intravenous cannula inserted prior to induction of general anaesthesia. Three minutes beforehand, a subcutaneous injection of 0.3 ml of 1% plain lidocaine was administered. Subjects were randomly allocated to receive the lidocaine either by the needleless injector or from a conventional syringe and a 25 G needle. Pain scores were recorded on injection of the lidocaine and on insertion of the cannula. There was significantly less pain on injection with the needleless injector than with the 25 G needle (p < 0.001) but, surprisingly, there was more pain on cannulation (p < 0. 001). We conclude that the device certainly delivers a less painful subcutaneous injection than a 25 G needle, but perhaps provides less effective skin anaesthesia for venous cannulation at sites where the subcutaneous space is small; its use might be better suited to areas where the subcutaneous space is deeper.

The feasibility of administering a relatively high dose of the gonadotrophin-releasing hormone (GnRH) antagonist ganirelix by means of a needle-free injection device, which could be useful in the long-term treatment of sex-steroid-dependent disorders, was evaluated in a randomized, crossover study in 16 healthy females. Local tolerance and pharmacokinetics of ganirelix administered by MediJector versus conventional needle injections were compared. Additionally, the pharmacodynamic effect was evaluated. Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period. No apparent differences in local tolerance were observed. Most injections (87.5%) gave either no or only a mild reaction. Of the moderate reactions, swelling and redness were reported most frequently (overall 4.9 and 8.5% per injection, respectively). Administration by Medi-Jector was bioequivalent to conventional needle injection with respect to the peak concentration and area under the curve. A profound suppression of luteinizing hormone and follicle stimulating hormone was observed. Serum oestradiol and progesterone concentrations were relatively low prior to treatment and remained low during the entire study period. In conclusion, administration of a relatively high dose of ganirelix by Medi-Jector might be useful for long-term treatment of sex-steroid dependent disorders.

The next several years promise dramatic changes in the treatment of diabetes, many of which will be driven by rapidly developing technology. Today's patient with diabetes has ready access to more information about the disease and its treatment options. As a result of this increased knowledge base, insulin-treated patients have become more autonomous in the management of their diabetes and may be better prepared to participate in making informed choices regarding insulin delivery devices. As with any insulin regimen, diabetes educators are encouraged to provide ongoing patient education and follow-up to assure optimal use of these new technologies.

Needle-less jet injectors were developed by the US army after World War II. Their principal use, however, has been in the administration of lyophilized vaccines from multidose vials to at-risk populations in developing countries. In 1983, a hepatitis B epidemic occurred among customers of a beauty clinic in California (USA) following the use of jet-injectors, demonstrating a clear risk of cross-contamination associated with this technique. As a result, the WHO and Unicef stopped recommending jet-injectors for collective immunizations in developing countries. To eliminate the risk of contamination, Pasteur Mérieux Sérums et Vaccins (now Aventis Pasteur) developed, in 1990, jet-injectors for use with single-use vaccine cartridges. These injectors were tested for tetanus toxoid, DTP, influenza, hepatitis A and typhoid Vi vaccination. The immunogenic reaction was as strong and the injection as well tolerated as for injections using a standard needle and syringe. The additional cost of the Imule technique was evaluated in a district-wide (127,000 inhabitants) tetanus toxoid immunization program at Velingara, Senegal in 1993. The total cost was estimated to be 1.51 FF (76 F CSA, 0.32 US dollars) for one dose of tetanus vaccine given by needle and syringe and 2.41 FF (121 F CSA, 0.56 US dollars) for one dose given by Imule. Thus, the additional cost of injection by ImuleTM was 0.90 FF (45 F CSA, 0.21 US dollars). The cost of cross infection in sub-Saharan Africa has been estimated to be 2.37 FF (118 F CSA, 0.55 US dollars) per injection if injection practices are not supervised. Therefore, the Imule technique may be considered to be cost-effective. However, the technique is still not completely reliable, as shown by the total breakdown of four jet injectors during this vaccination session. Lyophilized vaccines have also not been tested in the field. Vaccinators prefer Imule, training is easy and immunization can be carried out on a day-to-day basis with no vaccine wastage. Imule is not yet in mass production, which would reduce costs. In the face of the ever-increasing risk of cross-contamination during vaccination sessions in sub-Saharan Africa, the Imule technique deserves considerable attention.

We have used spring powered jet injectors to deliver a solution of a naked DNA vaccine encoding the influenza hemagglutinin HA into the skin of mice and monkeys. We compared the immune responses induced by this needleless injection technique into the skin to the responses induced by a classical i.m. immunization. Both routes of immunization induced significant ELISA antibody titers and hemagglutination inhibition (HI) titers that were above the usual threshold values predictive of protection against influenza in mice and monkeys. In mice, both ways of immunization were equally efficient in inducing HA-specific CTL responses. Regarding antibody isotypes, the IgG1/IgG2a ratio was in favour of the IgG2a isotype for i.m. immunization and more balanced for i.d. immunization. The ability of the two injection techniques to induce immunity in mice did not correlate with transgene expression in the site of administration. In fact, local gene expression was 10-100 fold more important in the injected muscle as compared to the jet-injected skin when assessed by using the luciferase reporter system.

A syringe jet injector is a device designed to administer a drug quickly and painlessly through the skin. Though syringe jet injectors have been in use for almost 50 years, current designs still suffer from inconsistent performance. To better understand the fluid mechanics of jet injection and gain insight into how the design might influence performance, two theoretical analyses to determine the fluid pressure profile at the exit orifice were conducted. The first was a continuum analysis assuming static incompressibility. Results demonstrated that the maximum jet pressure was highly sensitive to the spring constant, initial piston velocity, and piston cross-sectional area while the time to achieve the maximum pressure was most sensitive to the injection chamber length, initial piston velocity, bulk modulus of the injectant, and the piston cross-sectional area. The second analysis was a shock wave analysis. Results demonstrated a stepwise pressure-time plot that was similar in magnitude to that for the continuum analysis assuming static incompressibility. Results from these two investigations are useful for design modification of the jet injector to achieve desired pressure-time profiles at the orifice. Control of pressure-time profiles may help to achieve a more consistent and effective injection process.

High-velocity powder injection is a promising new drug-delivery technique that provides needle- and pain-free delivery of traditional drugs, drugs from biotechnology such as proteins, peptides, and oligonucleotides as well as traditional and genetic vaccines. The energy of a transient helium gas jet accelerates fine drug particles of 20 microns-100 microns diameter to high velocities and delivers them into skin or mucosal sites. This review describes the configuration and operating principles of devices that accelerate the particles, the required properties of the particles, the characteristics of the target tissues, and features of the developmental test methods. Preclinical and clinical results that best characterize the technology and introduce its potential as a drug-delivery platform are presented.

Purpose: The purpose of this study was to compare jet injection to a syringe and needle in terms of the difference in discomfort and pharmacokinetics after the subcutaneous administration of midazolam., Patients and Methods: Using a prospective, randomized, double-blinded study design, 14 subjects were administered midazolam on two separate occasions (at least 2 weeks apart). The subjects were randomly distributed into two groups: syringe and needle (saline)/jet injector (midazolam) or syringe and needle (midazolam)/jet injector (saline). The subjects were randomly assigned to receive either EMLA (eutectic mixture of local anesthetics) or a placebo at the injection site for the first administration and the other topical agent on the second visit. Each subject received one subcutaneous injection in the deltoid region per arm per day. Each injection contained the same volume of solution. Subjects completed visual analog scale (VAS) questionnaires assessing the discomfort of the injection. Blood samples were taken at specified intervals over 2 hours for determination of midazolam levels., Results: The discomfort associated with the injection was less with the Biojector 2000 (Bioject Inc, Portland, OR) although this was not statistically significant. However, persistent discomfort was significantly greater at the needle site. The mean peak plasma level of midazolam was achieved more rapidly with the Biojector 2000 than with the syringe and needle (P < .05). However, the peak plasma level after jet injection or injection with a syringe and needle was not statistically different., Conclusion: The results of the study show that the Biojector 2000 is a needle-free injection system that can be used for the administration of a premedicant before induction of anesthesia. It has several advantages, including the potential reduction of anxiety associated with the "fear of needles" and occupational injuries.

The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi-Jector results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi-Jector is a needle-free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two-period cross-over trial. A questionnaire was used to assess psychological responses such as non-compliance, opinion on ease of preparation, affective responses to administration and local side-effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi-Jector less offputting (p < 0.01), less painful with respect to both frequency (p < 0.04) and intensity (p < 0.01) and less unpleasant (p < 0.05) than a multidose injection pen with a 28G needle (p < 0.01). No difference in compliance was detected. Most subjects preferred the Medi-Jector for future use (p < 0.05). The mean score on a 1-10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi-Jector and 6.8 (SD 2.3) for the multidose injection pen (p < 0.08). The prevalence of visible bruises each day was higher (p < 0.01) with the Medi-Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi-Jector (p < 0.06). It is concluded that use of the Medi-Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles.

Objectives: Intracavernous needle injection is an effective delivery method for pharmacotherapy of erectile dysfunction. Needle phobia, pain, and concern about local tissue injury have stimulated the search for new, less invasive means of inducing penile erection. In this preliminary communication, we evaluate a jet injector as an alternative to needle injection for intracavernous delivery of vasoactive drugs., Methods: Jet injection was evaluated in three groups of rats receiving either India ink, saline, or papaverine into the penis. The ability of the jet injection to penetrate through the tunica albuginea and deliver liquid to the corpora cavernosa smooth muscle was assessed by the degree of staining within the corpus cavernosum (ink group), histologic change (saline group), and rise in intracavernous pressure (papaverine group). Erectile capacity following cavernous nerve electric stimulation was compared before and 1 hour after injection of saline or papaverine., Results: Ink traversed the skin and tunica albuginea with extensive deposition noted within the cavernous spaces. Varying degree of subcutaneous hemorrhage were seen with saline jet injection; however, the corpus cavernous smooth muscles showed no evidence of injury. Jet injection of papaverine 3250 micrograms significantly increased cavernous pressure (39.4 +/- 4.6 cm H2O) compared with saline injection (2.8 +/- 1.3 cm H2O)., Conclusions: We conclude that acute jet injection is an effective method for intracavernous delivery of drugs. Long-term effects should be evaluated prior to clinical use.

Jet injectors may transmit blood-borne infections, such as hepatitis B virus (HBV) and human immunodeficiency virus (HIV). To evaluate the safety of an anticontaminant disposable device which protects the jet injector apparatus, 22,714 healthy subjects were intradermally inoculated (38,162 inoculations) with a variety of vaccines. All the subjects were systematically followed-up clinically and epidemiologically for 6-18 months after inoculation; blood samples from 1619 subjects, before and 60-75 days after inoculation, were examined by enzyme-linked immunosorbent assay (ELISA) for HBV, hepatitis C virus (HCV) and HIV. Before vaccination 212 (13.09%) subjects were positive: 204 positive for HBV markers and eight for the HCV marker. None of the subjects were positive for the anti-HIV marker. During the clinico-epidemiological surveillance and the laboratory investigations mentioned above no clinical viral hepatitis B or C case and no seroconversion to positivity for HBV or HCV markers among the susceptible persons in the group were reported. Considering that in similar situations there is a theoretical risk of transmission as high as 1 per 388 to 1 per 3367 injections and that in our case 38,162 inoculations were performed in 22,714 subjects with the same Dermojet protected by the same type of anticontaminant disposable device, no contamination risk being reported, the conclusion can be reached that jet injectors can be safely used in the medical practice if they are protected by the sterile anticontaminant disposable device.

A simple and inexpensive particle-bombardment device, the OPgun, was constructed for the delivery of DNA into animal tissues. This device is based on the particle-inflow gun first described for plant-cell transfection. The delivery of tungsten particles into the epidermis of the mouse ear, without the use of vacuum and without causing damage to the tissue, was demonstrated. The system was also shown to be capable of inducing antibodies to a foreign gene in mice.

A new needleless jet-injector, Mini-Imojet, was developed that administers liquid vaccines from a single-use, pre-filled cartridge named Imule, which avoids the risk of cross-contamination. We conducted clinical trials in several settings in France and West Africa to compare the immunogenicity and tolerance of five vaccines (influenza vaccine, Vi capsular polysaccharide typhoid vaccine, tetanus toxoid vaccine, diphtheria-tetanus-whole cell pertussis vaccine, and inactivated hepatitis A vaccine) administered with the Imule system vs standard syringe technique. In each vaccine study, all subjects of either group were tested for serum antibody titres to calculate the geometrical mean titres and seroconversion rates after complete vaccination. Immediate local-reactions were noted after each injection, and local and general reactions were evaluated during a predetermined period of follow-up. When delivered by the Imule technique, all the administered vaccines were of equivalent or superior immunogenicity, compared to the syringe technique. The tolerance to vaccines injected by the Imule system was acceptable in all studies. The most frequently observed reactions were mild (e.g. minor bleeding, superficial papules, erythema and induration) and could be considered to be inherent to the injection technique. The technical and safety advantages of the Mini-Imojet/Imule system, compared to sterilizable, standard disposable or autodestruct syringes and to classical multi-dose vial jet-injectors, reinforces the interest of this new injection technique for collective immunizations.

An open randomized controlled clinical trial was conducted to compare the reactogenicity of a recombinant hepatitis B vaccine (Engerix-B) when injected with the Bioject device (a pneumatically powered drug delivery system using disposable syringes) or with conventional syringe and needle, according to a 0.1 and 6 month vaccination schedule. Ninety-seven healthy young adults were enrolled in this study. Participants were asked to record local and general solicited symptoms and signs after each vaccination and to report each unsolicited symptom and sign that occurred during the study. The use of the jet-gun induced a statistically significant higher incidence of local symptoms and signs (solicited and unsolicited) than the use of syringe and needle.

A simple device for making pressure microinjections into the brain, its application for delivery of a tracer substance, biotin dextran amine, and an example of the resulting axonal transport are described. The device is based on the use of a Luer Up Hamilton microliter syringe mated directly to the plastic hub of an injection needle assembly in which the metal needle has been replaced by a glass pipette. In model experiments, the injection sites were measured in brain sections of rats, which were perfused with fixative immediately after administration of the tracer, and the relationship between the injected volume and the area of the injection site was evaluated. The results showed that the device provided accurate and reproducible delivery of the fluid.

The pig model was used for experiments with a new type of water-jet dissector, which produces high-pressure water by application of a gas and maintains the water fully sterile in a single-use delivery apparatus. The experiment was conducted ex vivo (14 kidneys) and in vivo to compare electric cautery section with water-jet dissection (5 vs 11 partial nephrectomies). Ex vivo study confirmed sparing of blood vessels and pelvicaliceal system. In vivo study did not show significant differences in blood loss but, the water-jet allowed precise dissection and tight closure of the excretory system. More frequent haemorrhages were noted on histological examination of the WJ group, but no coagulation necrosis. These are preliminary findings and further studies of long-term results may confirm the benefits of the absence of parenchymal necrosis and the definite advantage of precise closure of the pelvicaliceal system, as morbidity of partial nephrectomy is often related to secondary haemorrhages and urinary fistulae.

Background: Jet injection eliminates the risk of contaminated needlestick injuries when giving intramuscular or subcutaneous medications. Clinical efficacy of the Biojector System was equivalent to that of needle and syringe injection in unpublished trials with vaccines, but had not been studied using other drugs., Objective: To compare the effectiveness of the Biojector with conventional needle and syringe injection in administering intramuscular morphine and subcutaneous heparin to healthy adults, as measured by plasma drug concentration., Methods: Intramuscular injections of morphine 8 mg (5 mg if weight < or = 65 kg) were given 24 hours apart with the jet injector and with a needle and syringe to 30 subjects at the deltoid site and 10 subjects at the dorsogluteal site. Blood samples for plasma concentrations of free morphine were drawn at 15, 30, 45, 60, 120, and 240 minutes and were analyzed using radioimmunoassay. Abdominal subcutaneous injections of heparin 3500 U were given every 8 hours for 5 days with both injection methods to 29 subjects, with 48 hours between the two series. Daily blood samples for plasma heparin were analyzed by colorimetric assay for antifactor Xa activity., Results: Mean free morphine concentration, peak value, and area under the curve did not differ significantly between the deltoid and dorsogluteal sites or between the jet injector and needle and syringe. Values of mean daily heparin concentrations and area under the curve were low and did not differ between the two injection methods., Conclusion: Plasma drug concentrations provided by the Biojector were equivalent to those provided by conventional needle and syringe when administering intramuscular morphine and low-dose subcutaneous heparin.

In order to shorten anaesthesia induction and to avoid pain of the intramuscular injection, we evaluated the efficacy and safety of midazolam given by a jet-injector, utilized solely for mass inoculations until now. Premedication with midazolam with the jet-injector, indeed, proved to be effective, rapid and safe in children. The best results were found in two groups receiving 150-200 microgram/kg midazolam. Within 5 minutes, it was easy to cannulate a vein in children injected by the jet-injector, whereas the effect of intramuscular injection developed slowly, within 7 minutes. In the latter group, cannulation of the vein was more difficult than in the other groups. The separation from the parents and anaesthetic induction were greatly facilitated by midazolam given by the jet-injector. Amnesia was present not only for anaesthetic induction but also for the injection. Recovery was not more prolonged in those premedicated with midazolam with the jet-injector than with midazolam administered by other routes: oral, rectal or nasal. The children induced with the aid of jet-injector had no unpleasant recall based on interviews with the patients and parents.

A newly developed autoinjector (Astra Tech, Sweden) containing 500 mg HI-6 and 2 mg atropine sulphate was tested in anaesthetized normal pigs. The pharmacokinetics and pharmacodynamics of the drugs after administration by the autoinjector were compared with those after conventional needle and syringe delivery intramuscularly and intravenously. Cardiopulmonary parameters were monitored and serum concentrations of oxime, atropine, and acetylcholinesterase were determined in blood samples taken at intervals over a 6 h period postinjection. After injection in anaesthetized pigs, both HI-6 and atropine were absorbed rapidly and completely from the injection site. Therapeutic serum concentrations of HI-6, arbitrarily taken as 4 micrograms mL-1, were reached within 1 min of intravenous and autoinjector administration, and within 5 min of intramuscular injection. The concentrations remained above this level for 3-4 h. There were no significant changes in acetylcholinesterase activity, mean arterial blood pressure, or respiration frequency after injection of HI-6 and atropine sulphate. The heart rates increased significantly after administration of the two drugs (cardioacceleration defined as > or = 5% increase in heart rate), regardless of the technique employed. Our results show that HI-6 and atropine sulphate can be given intramuscularly by the new autoinjector with the same effectiveness and speed as when given intravenously. Irrespective of the injection technique, no overt signs of toxicity were observed at the drug concentrations used.

Background: A rapid, dependable, and economical technique to atraumatically sedate children before anesthesia that does not prolong postanesthesia care unit time remains elusive. The Biojector jet injection system uses carbon dioxide rather than a needle to deliver an intramuscular injection. The dose-response relationship when midazolam is administered was studied using this jet injector., Methods: Forty children (2.3 +/- 1.3 yr old) undergoing elective myringotomy and tube placement were randomly assigned to receive 0.05, 0.1, 0.15, 0.2, or 0.3 mg.kg-1 midazolam injected intramuscularly using the Biojector disposable syringe (0.006-inch orifice). Assessment of each child before, during, and 10 min after injection, on application of the anesthesia face mask, and every 15 min for 1 h after arrival to the postanesthesia care unit was made by an observer blinded to drug dosage., Results: Face mask tolerance using doses > or = 0.1 mg.kg-1 midazolam was acceptable and statistically different from 0.05 mg/kg. Crying on injection tended to increase with increasing dose. All children were awake and arousable, meeting discharge criteria, after 30 min from arrival in the postanesthesia care unit., Conclusions: Midazolam (0.1-0.15 mg.kg-1) administered using jet injection effectively and rapidly produces sedation, in a manner acceptable to parents, without delaying postanesthesia care unit discharge.

Background: Pain and needle-phobia can be a problem during the application of local anesthesia with syringe and needle., Objective: To evaluate a jet-injection device (without needle) to deliver local anesthesia., Methods: Two hundred and six minor dermatological procedures using a jet-injection device for administering local anesthesia into skin tissue were performed. We comment on the technical procedures, application, usefulness in relation to areas involved and the anatomical location of lesion, and total dosage of the anesthetic agent., Results: Total absence of pain during installation of anesthetic (N = 194; 94%). Good level of anesthesia in all patients. No local adverse effects., Conclusion: The jet-injection device is easy to handle, it is harmless, it provides good levels of anesthesia, and the dosage of anesthetic agent is smaller than the dosage administered with conventional methods.

The therapeutic effectiveness of a new binary autoinjector containing 500 mg HI-6 and 2 mg atropine sulphate was tested in anesthetized pigs poisoned by a lethal dose of soman i.v. (9 micrograms/kg per 20 min). Pharmacokinetics and pharmacodynamics of HI-6 were studied concomitantly on administration of HI-6 alone, together with atropine sulphate, or together with atropine sulphate during soman intoxication. Cardiopulmonary parameters were monitored and serum concentrations of oxime and acetylcholinesterase (AChE) were measured in blood samples taken at intervals over a 6-h period postinjection. Five minutes after the start of soman infusion, mean AChE activity was decreased to 27 +/- 4.3% of baseline and signs of poisoning appeared. The antidotes, HI-6 and atropine sulphate, were then administered i.m. One minute after this injection there was a transient significant increase in AChE activity of 76 +/- 8.2% of baseline (p < 0.01). It then again decreased and remained suppressed throughout the experiment. Mean respiratory rate was significantly decreased (p < 0.01) to 20 +/- 3.2% of baseline after 20 min of soman infusion and remained low during the rest of the experiment. The poisoning signs were counteracted 15-20 min after antidote therapy and all pigs survived soman intoxication without ventilatory assistance. Administration of either atropine or atropine and soman had no significant effect on the pharmacokinetics of HI-6 in anesthetized pigs.

We characterize a method by which the Med-E-Jet pneumatic vaccination gun can be used to propel intact, supercoiled plasmid DNA through skin and into skeletal muscles of mice. Intramuscular injection of plasmids containing the firefly luciferase gene linked to the human cytomegalovirus promoter resulted in the expression of several hundred picograms of luciferase enzyme in quadriceps muscles. Intramuscular injections of a plasmid containing the influenza A nuclear protein gene regulated by the same promoter resulted in the generation of potent and specific anti-nuclear protein humoral and cellular immune responses. This convenient and rapid injection method would be well-suited for genetic immunization of humans.

The analysis of literature doesn't give strong confirmation that jet injection could provoke the transmission of the infection. Nevertheless such infection is possible because of retrograde flow of vaccine preparation which just has mixed with tissue liquid of a previous patient or taking into account a continuous contact of an injector head with patient's skin during injection. The design of the injector head has a certain significance on this matter. These risk factors can be eliminated by strict observation of rules for handling these instruments. It's necessary to conduct additional experimental researches to prove or refute the safety of jet injections.

The local anaesthetic procedure is often painful to the patient. During a period of 21 weeks, jet injection was used as the anaesthetic procedure in 55 cases of minor surgery in a single general practice. The application is discussed, giving a variety of examples. The method provides a simple and almost pain-free anaesthetic procedure in the majority of minor surgical operations. The amount of anaesthetic is reduced. The method is particularly suitable for anaesthetizing sensitive areas like the finger of a child or verrucas.

The ability to use the same micropipette for simultaneous pressure microejection and field potential recording ('spot pressure electrode') is described. This approach allows the use of a single electrode to record both field responses to pressure microejection of drugs (fPR) and synaptically evoked field excitatory postsynaptic potentials (fEPSP). To demonstrate this, the glutamate receptor agonists alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionate (AMPA, 100-300 microM) and N-methyl-D-aspartate (NMDA, 1 mM) were used. Both AMPA- and NMDA-evoked fPRs exhibited properties of postsynaptic responses. Thus, they were not significantly altered by tetrodotoxin (TTX, 0.5-1 microM), but were completely and reversibly blocked by an antagonist of AMPA/kainate receptors, 6-cyano-7-nitroquinoxaline-2,3-dione (CNQX, 20 microM) and D-2-amino-5-phosphonopentanoic acid (AP5, 20 microM), respectively. The responses to micropressure-ejected AMPA were more stable and probably restricted to a smaller locus than responses to iontophoretic AMPA ejection. Additionally, the AMPA and NMDA contained in the pipette (up to 500 microM) did not influence the fEPSP recorded with this pipette. Our results suggest that this method might be a useful experimental tool for studying the local effects of excitatory amino acids and other compounds.

A comparative analysis of the effectiveness of revaccination of 1595 schoolchildren with the BCG and BCG-M vaccine is given in relation to the method of vaccine administration and revaccination frequency (1st revaccination was given in the 1st and 2nd in the ninth form). Both vaccines were found to be equally effective both in the development of a postvaccination skin sign and postvaccination allergy. The method of BCG vaccine administration (with a jet injector and needle syringe) had no essential influence on the revaccination effect. The advantage of a new BI-19 jet injector used for tuberculin diagnosis consisted in that there was no need to adjust the results of tuberculin diagnosis as was the case with a previous BI-IM jet injector.

In order to study whether the bioavailability of subcutaneously injected growth hormone (GH) is dependent on the concentration/volume injected, the relative GH bioavailability was evaluated in 14 GH-deficient patients. In a cross-over study the patients received, in random order two separate subcutaneous GH injections (Norditropin) 4 IU administered by means of an ordinary syringe (4 IU ml) and an injection pen with cartridge (Nordiject 24) (12 IU/ml). Blood samples were drawn over a 14 hr period and assayed for serum concentrations of GH and IGF-I. The mean value (+/- S.D.) of the relative absorption fraction (Fpen/sy) was 1.09 +/- 0.39. Mean values of Cmax were 8.6 ng/ml +/- 4.8 and 8.3 ng/ml +/- 7.5 for syringe and pen respectively. Corresponding values for Tmax were 311 min. +/- 131 for syringe and 309 min. +/- 104 for pen. Although a considerable interindividual variation was seen, the relative absorption fraction did not differ significantly from 1 (2 P = 0.78). Further there was no significant difference in neither Cmax (2 P = 0.39) nor Tmax (2 P = 0.55). IGF-I serum profiles tended to be higher following syringe compared to pen injection (2 P = 0.054). On the basis of this study we conclude that in this dosage regimen. GH bioavailability following pen injection equals that of injection by syringe (i.e. no effect of a three fold increase/decrease in GH concentration/volume respectively).

Jet injectors, which force a fluid under considerable pressure through a very small opening, have recently become available for subcutaneous administration of insulin. Use of the new devices introduced on the market is neither simpler nor more complicated than use of a syringe. Although jet injectors are highly attractive to both patients and parents, they can be used in only a limited range of diabetics. Main limitations to more widespread use include: 1) the small capacity of the devices which cannot inject more than 20 units of 40 unit/ml insulin; 2) modifications in the pharmacokinetic effects of insulins, especially long-acting insulins; 3) the high price of the injectors. Young children, who often find it difficult to accept injections, may be the main potential target for jet injector therapy. A trial period at home should always be scheduled before considering the purchase of a jet injector.

From January 1984 through November 1985, 31 clinical cases of hepatitis B occurred among attendees of a weight reduction clinic (clinic 1). Before the onset of illness, each case-patient had received a series of injections of human chorionic gonadotropin administered by jet injectors at clinic 1. Clinical history, risk factor assessment, serologic evaluation, and review of clinic injection records were obtained on 287 (84%) of 341 persons who had attended clinic 1 in the first 6 months of 1985. Of this cohort, 21% (60/287) had evidence of acute infection with hepatitis B virus (either documented clinical cases or antibody to hepatitis B core antigen, IgM positive). Of persons who had been given human chorionic gonadotropin at the clinic during the period studied, 24% (57/239) of those receiving human chorionic gonadotropin only by jet injector experienced acute hepatitis B virus infection. None of the 22 persons who had received injections only by syringe experienced hepatitis B virus infection. Stopping the use of the jet injectors on July 2, 1985, at clinic 1, was associated with the termination of this outbreak. This investigation demonstrated that jet injectors can become contaminated with hepatitis B virus and then may be vehicles for its transmission.

Visualization of the coronary arteries during all phases of percutaneous transluminal coronary angioplasty using hand-held contrast media injection devices is suboptimal. Power injection of contrast media for diagnostic coronary cineangiography has been performed in over 18,000 cases without power injector complication. Here we report our experience with 294 patients using power injection for visualization during all phases of PTCA. It provides optimal visualization of the coronary arteries and has not been associated with complications. It is a safe and efficient system with reduction in both the time and radiation exposure required to perform PTCA and allows determination of the adequacy of the result without unnecessary recrossing of the area of dilatation.

Nine shapes of clamping pads for injector syringes were tried out in the course of mass immunoprophylaxis (34 thousand injections). The reliable locking of injectors was judged about by the frequency and intensity of complications. Optimal shapes of clamping pads were determined, the ones suitable to be used for mass immunoprophylaxis that ensure, alongside a regular performance of high-quality subcutaneous injections, a firm fixation of the injector in the skin at the time of vaccination.