咪达唑仑经黏膜给药用于小儿患者的术前用药。鼻内给药与舌下给药途径的比较。

Transmucosal administration of midazolam for premedication of pediatric patients. Comparison of the nasal and sublingual routes.

作者信息

Karl H W, Rosenberger J L, Larach M G, Ruffle J M

机构信息

Department of Anesthesia, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey.

出版信息

Anesthesiology. 1993 May;78(5):885-91. doi: 10.1097/00000542-199305000-00013.

DOI:10.1097/00000542-199305000-00013

PMID:8489062

Abstract

BACKGROUND

Nasal transmucosal midazolam is effective for premedication of pediatric patients; however, 61-74% of these patients cry at nasal drug administration. Sublingual benzodiazepines, including midazolam, are effective in adults. The current blinded randomized study compared acceptance of and behavioral responses to transmucosal midazolam administered via the intranasal and sublingual routes.

METHODS

Ninety-three patients aged 0.5-10 yr were stratified by age: 30 infants and toddlers, 0.5-2 yr; 39 preschoolers, 2.1-5 yr; and 24 school age, 5.1-10 yr. They were randomized to receive 0.2 mg/kg of midazolam in the nose or under the tongue without or with additional flavoring. For the group receiving sublingual flavored midazolam, the syringe tip was dipped in candy flavor and sugar. Duration of crying and compliance with instructions for sublingual drug administration were recorded. Hemoglobin oxygen saturation by pulse oximetry and sedation score were recorded by three observers before drug administration, at 2.5-min intervals for 10 min, at separation from parents, and during induction with halothane in O2.

RESULTS

Children accepted midazolam administered via the sublingual route better than that given intranasally. In children not crying before drug administration, the frequency and duration of crying was greater following intranasal compared with sublingual administration (71% vs. 18% (P < 0.0001) and 48 +/- 56 vs. 25 +/- 49 s (P = 0.004), respectively). Lack of total compliance with instructions for sublingual administration did not alter drug effect, and there were no differences between the three study groups in maximum sedation, response to separation from parents, and behavior at induction of anesthesia; 80% displayed adequate or excellent behavior. Finally, the addition of candy flavor did not improve acceptance of or compliance with sublingual midazolam administration.

CONCLUSIONS

Sublingual administration of midazolam is as effective as, and better accepted than, intranasal midazolam as a preanesthetic sedative in children.

摘要

背景

经鼻黏膜给予咪达唑仑对小儿患者术前用药有效；然而，61% - 74%的此类患者在经鼻给药时会哭闹。包括咪达唑仑在内的舌下含服苯二氮䓬类药物对成人有效。当前这项双盲随机研究比较了经鼻和舌下途径给予经黏膜咪达唑仑时的接受度及行为反应。

方法

93例年龄在0.5 - 10岁的患者按年龄分层：30例婴幼儿，0.5 - 2岁；39例学龄前儿童，2.1 - 5岁；24例学龄儿童，5.1 - 10岁。他们被随机分为在鼻内或舌下接受0.2mg/kg咪达唑仑，给药时不加或加额外调味剂。对于接受加味舌下咪达唑仑的组，将注射器尖端蘸上糖果味和糖。记录哭闹持续时间以及对舌下给药说明的依从性。在给药前、给药后10分钟内每隔2.5分钟、与父母分离时以及在O₂中用氟烷诱导麻醉期间，由三名观察者记录经脉搏血氧饱和度测定的血红蛋白氧饱和度和镇静评分。

结果

儿童对经舌下途径给予的咪达唑仑接受度优于经鼻给予的咪达唑仑。在给药前未哭闹的儿童中，与舌下给药相比，经鼻给药后哭闹的频率和持续时间更高（分别为71%对18%（P < 0.0001）和48 ± 56秒对25 ± 49秒（P = 0.004））。对舌下给药说明缺乏完全依从性并未改变药物效果，且三个研究组在最大镇静程度、对与父母分离的反应以及麻醉诱导时的行为方面无差异；80%表现出良好或优秀的行为。最后，添加糖果味并未提高对舌下咪达唑仑给药的接受度或依从性。