• J. Oral Maxillofac. Surg. · Nov 1998

    Randomized Controlled Trial Comparative Study Clinical Trial

    Subcutaneous administration of midazolam: a comparison of the Bioject jet injector with the conventional syringe and needle.

    • J Bennett, F Nichols, M Rosenblum, and J Condry.
    • Department of OMFS, University of Connecticut School of Dental Medicine, Farmington 06030, USA.
    • J. Oral Maxillofac. Surg. 1998 Nov 1;56(11):1249-54.

    PurposeThe 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 MethodsUsing 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.ResultsThe 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.ConclusionThe 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.

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