咪达唑仑的皮下给药：Bioject喷射注射器与传统注射器和针头的比较。

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

作者信息

Bennett J, Nichols F, Rosenblum M, Condry J

机构信息

Department of OMFS, University of Connecticut School of Dental Medicine, Farmington 06030, USA.

出版信息

J Oral Maxillofac Surg. 1998 Nov;56(11):1249-54. doi: 10.1016/s0278-2391(98)90601-2.

DOI:10.1016/s0278-2391(98)90601-2

PMID:9820211

Abstract

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.

摘要

目的

本研究旨在比较喷注式注射与注射器和针头在皮下注射咪达唑仑后不适程度和药代动力学方面的差异。

患者与方法

采用前瞻性、随机、双盲研究设计，14名受试者在两个不同时间（间隔至少2周）接受咪达唑仑注射。受试者被随机分为两组：注射器和针头（生理盐水）/喷注式注射器（咪达唑仑）组或注射器和针头（咪达唑仑）/喷注式注射器（生理盐水）组。首次给药时，受试者被随机分配在注射部位接受EMLA（局部麻醉剂共熔混合物）或安慰剂，第二次就诊时接受另一种局部用药。每位受试者每天每只手臂的三角肌区域接受一次皮下注射。每次注射的溶液体积相同。受试者完成视觉模拟量表（VAS）问卷以评估注射的不适程度。在2小时内按特定间隔采集血样以测定咪达唑仑水平。

结果

使用Biojector 2000（Bioject公司，俄勒冈州波特兰市）注射时相关不适较轻，尽管这在统计学上无显著差异。然而，针头注射部位的持续不适明显更严重。与注射器和针头相比，Biojector 2000使咪达唑仑的平均血浆峰值水平更快达到（P <.05）。然而，喷注式注射或注射器和针头注射后的血浆峰值水平在统计学上无差异。