一项随机、对照、交叉临床试验，比较静脉注射咪达唑仑镇静与一氧化二氮镇静用于拔牙儿童的效果。
Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions.
作者信息
Wilson K E, Girdler N M, Welbury R R
机构信息
Department of Sedation, Newcastle Dental School and Hospital, Framlington Place, Newcastle-upon-Tyne NE2 4BW, UK.
出版信息
Br J Anaesth. 2003 Dec;91(6):850-6. doi: 10.1093/bja/aeg278.
BACKGROUND
The use of benzodiazepines for paediatric dental sedation has received limited attention with regard to research into clinical effectiveness. A study was therefore designed to investigate the use of midazolam, for i.v. sedation in paediatric dental patients.
METHOD
The aim of the study was to assess the effectiveness of i.v. midazolam in a randomized, controlled, cross-over trial. Children aged 12-16 yr (ASA I and II), requiring two appointments for equivalent but contralateral dental extractions for orthodontic purposes, were recruited. Conscious sedation with either i.v. midazolam titrated at 0.5 mg x min(-1), to a maximum of 5 mg, or nitrous oxide/oxygen titrated to 30%/70% inhalation sedation was used at the first visit, the alternative being used at the second visit. Vital signs including blood pressure, arterial oxygen saturation and ventilatory frequency, as well as sedation levels and behavioural scores, were recorded every 2 min.
RESULTS
Forty patients, mean age 13.2 yr (range 12-16 yr), participated in the trial. A mean dose of midazolam 2.8 mg was administered in the test group. The median time to the maximum level of sedation was 8 min for midazolam compared with 6 min for nitrous oxide (P<0.001). Vital signs for both treatments were comparable and within acceptable clinical limits and communication with the patient was maintained at all times. The median (range) lowest arterial oxygen saturation level recorded for midazolam was 97 (91-99)% compared with 97 (92-100)% for nitrous oxide. The mean (range) recovery time for midazolam was 51.6 (39-65) min and 23.3 (20-34) min for nitrous oxide (P<0.0001). Fifty-one per cent said they preferred i.v. midazolam, 38% preferred nitrous oxide, and 11% had no preference.
CONCLUSION
I.V. midazolam sedation (0.5 mg x min(-1) to a maximum of 5 mg) appears to be as effective as nitrous oxide sedation in 12-16-yr-old healthy paediatric dental patients.
背景
苯二氮䓬类药物用于儿科牙科镇静在临床疗效研究方面受到的关注有限。因此设计了一项研究来调查咪达唑仑在儿科牙科患者静脉镇静中的应用。
方法
该研究的目的是在一项随机、对照、交叉试验中评估静脉注射咪达唑仑的有效性。招募了年龄在12至16岁（ASA I和II级）、因正畸需要分两次就诊进行同等但对侧牙齿拔除的儿童。首次就诊时采用静脉注射咪达唑仑，以0.5 mg·min⁻¹的速度滴定，最大剂量为5 mg，或采用氧化亚氮/氧气滴定至30%/70%的吸入镇静，第二次就诊时采用另一种方法。每2分钟记录一次生命体征，包括血压、动脉血氧饱和度和呼吸频率，以及镇静水平和行为评分。
结果
40名患者参与了试验，平均年龄13.2岁（范围12至16岁）。试验组咪达唑仑的平均剂量为2.8 mg。咪达唑仑达到最大镇静水平的中位时间为8分钟，而氧化亚氮为6分钟（P<0.001）。两种治疗的生命体征具有可比性，且在可接受的临床范围内，并且始终保持与患者的沟通。咪达唑仑记录的最低动脉血氧饱和度水平中位数（范围）为97（91至99）%，氧化亚氮为97（92至100）%。咪达唑仑的平均（范围）恢复时间为51.6（39至65）分钟，氧化亚氮为23.3（20至34）分钟（P<0.0001）。51%的人表示他们更喜欢静脉注射咪达唑仑，38%的人更喜欢氧化亚氮，11%的人没有偏好。
结论
在12至16岁的健康儿科牙科患者中，静脉注射咪达唑仑镇静（0.5 mg·min⁻¹，最大剂量为5 mg）似乎与氧化亚氮镇静一样有效。
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