右美托咪定联合咪达唑仑与单用咪达唑仑用于儿童口腔治疗镇静的随机对照临床试验。
Effect of Dexmedetomidine with or without Midazolam during procedural dental sedation in children: a randomized controlled clinical trial.
机构信息
Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafr El Sheikh, Egypt.
Faculty of Medicine, Alexandria University, Alexandria, Egypt.
出版信息
BMC Oral Health. 2024 Oct 26;24(1):1298. doi: 10.1186/s12903-024-04992-2.
BACKGROUND
Dental anxiety is a global problem in the realm of pediatric dentistry. The use of procedural sedation is recommended to avoid substandard or unsafe dental treatment in preschoolers. This study aimed to compare the effect sedation with Dexmedetomidine with or without Midazolam in terms of sedation level, analgesic effect and ease of treatment completion in preschool children.
METHODS
A triple blind randomized controlled clinical trial comprised 72 healthy uncooperative children, 4-6 years old, were randomly allocated into three groups of 24 patients each: Group I patients were sedated with nebulized 5 μg/kg Dexmedetomidine (DEX), Group II with nebulized 3 μg/kg DEX followed by nebulized 0.3 mg/kg Midazolam (MID), and Group III with nebulized 0.5 mg/kg MID. Along the session, the three regimens were assessed and compared during the sedation level (children responsiveness) using the Modified Observer's Assessment of Alertness/Sedation Scale, the analgesic effect using the Face, Leg, Activity, Cry, Consolability scale and ease of treatment completion using a separate 5-point scale. Vital signs were recorded before and during sedation, until full recovery.
RESULTS
A significant difference was detected regarding children responsiveness during operative procedure in favour of DEX in comparison to MID and DEX/MID groups (P = 0.045). Within the DEX group, a significant difference was recorded regarding children responsiveness at optimum sedation and during the operative procedure (P = 0.04). Although, the analgesic effects of sedative drugs showed no statistically significant difference among the study groups (P = 0.20), the ease of treatment completion was statistically higher in the DEX than MID and DEX/MID groups (P = 0.03).
CONCLUSION
Dexmedetomidine provides a moderate level of sedation, that allowed better patient cooperation, and easy completion of performed dental procedures.
背景
在儿童牙科领域，牙科焦虑是一个全球性问题。建议使用程序性镇静来避免学龄前儿童接受不合标准或不安全的牙科治疗。本研究旨在比较右美托咪定联合/不联合咪达唑仑镇静在学龄前儿童镇静水平、镇痛效果和治疗完成难易程度方面的效果。
方法
一项三盲随机对照临床试验纳入了 72 名健康、不合作的 4-6 岁儿童，将他们随机分为三组，每组 24 名患者：I 组患者接受 5μg/kg 右美托咪定（DEX）雾化吸入镇静，II 组患者接受 3μg/kg DEX 雾化吸入后接受 0.3mg/kg 咪达唑仑（MID）雾化吸入，III 组患者接受 0.5mg/kg MID 雾化吸入。在整个治疗过程中，采用改良的警觉/镇静观察量表（Modified Observer's Assessment of Alertness/Sedation Scale）评估并比较三组患者的镇静水平（患儿反应能力），采用面部、腿部、活动、哭闹、安慰评分（Face, Leg, Activity, Cry, Consolability scale）评估镇痛效果，采用单独的 5 分制评估治疗完成的难易程度。记录镇静前后和整个镇静过程中的生命体征，直到完全恢复。
结果
在手术过程中，患儿反应能力方面，DEX 组与 MID 组和 DEX/MID 组相比具有显著差异（P=0.045）。DEX 组中，最佳镇静和手术过程中患儿反应能力方面有显著差异（P=0.04）。虽然镇静药物的镇痛效果在研究组之间无统计学差异（P=0.20），但 DEX 组的治疗完成难易程度明显高于 MID 组和 DEX/MID 组（P=0.03）。
结论
右美托咪定可提供适度镇静水平，使患儿更好地配合，并轻松完成口腔治疗。
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