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儿童拔牙时经黏膜咪达唑仑与吸入镇静的比较:一项随机、交叉临床试验。

Comparison of transmucosal midazolam with inhalation sedation for dental extractions in children. A randomized, cross-over, clinical trial.

作者信息

Wilson K E, Welbury R R, Girdler N M

机构信息

Department of Sedation, Newcastle University School of Dental Sciences and Dental Hospital, Newcastle upon Tyne, UK.

出版信息

Acta Anaesthesiol Scand. 2007 Sep;51(8):1062-7. doi: 10.1111/j.1399-6576.2007.01391.x.

Abstract

BACKGROUND

The transmucosal route for conscious sedation in children has been reported widely in the field of medicine, but less so in dental patients. The aim of this study was to evaluate the efficacy and safety profile of midazolam (0.2 mg/kg) administered by the buccal transmucosal route, in comparison with nitrous oxide/oxygen inhalation sedation, for orthodontic extractions in 10-16-year-old dental patients.

METHODS

Each patient attended for two visits and was randomly allocated to receive buccal midazolam (0.2 mg/kg) or nitrous oxide/oxygen titrated to 30%/70% at the first visit, the alternative being used at the second visit. The patients' vital signs, sedation levels and behavioural scores were recorded throughout. Post-operatively, side-effects, recall of the visit and satisfaction levels were recorded via questionnaire.

RESULTS

Thirty-six patients, with a mean age of 12.9 years, completed both arms of the trial. The maximum level of sedation was achieved with buccal midazolam in a mean time of 14.42 min, compared with 7.05 min with inhalation sedation. The vital signs with both types of sedation remained within acceptable limits and the reported side-effects were of no clinical significance. Buccal midazolam was found to be acceptable by 65.7%. Only 28.6% of cases preferred this technique, the main disadvantage being the taste of the solution.

CONCLUSION

Buccal midazolam sedation (0.2 mg/kg) seems to be equally as safe and effective as nitrous oxide/oxygen for the extraction of premolar teeth in anxious children. However, further research is required to refine the midazolam vehicle to improve acceptability.

摘要

背景

经黏膜途径用于儿童清醒镇静在医学领域已有广泛报道,但在牙科患者中应用较少。本研究的目的是评估10 - 16岁牙科患者在正畸拔牙时,经颊黏膜途径给予咪达唑仑(0.2mg/kg)与氧化亚氮/氧气吸入镇静相比的有效性和安全性。

方法

每位患者就诊两次,首次就诊时随机分配接受颊部咪达唑仑(0.2mg/kg)或滴定至30%/70%的氧化亚氮/氧气,第二次就诊时使用另一种方法。全程记录患者的生命体征、镇静水平和行为评分。术后通过问卷调查记录副作用、对就诊的回忆和满意度。

结果

36名平均年龄为12.9岁的患者完成了试验的两个阶段。颊部咪达唑仑达到最大镇静水平的平均时间为14.42分钟,而吸入镇静为7.05分钟。两种镇静方式下的生命体征均保持在可接受范围内,报告的副作用无临床意义。65.7%的患者认为颊部咪达唑仑是可接受的。只有28.6%的病例更喜欢这种技术,主要缺点是溶液的味道。

结论

对于焦虑儿童拔除前磨牙,颊部咪达唑仑镇静(0.2mg/kg)似乎与氧化亚氮/氧气一样安全有效。然而,需要进一步研究改进咪达唑仑载体以提高可接受性。

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