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直肠给药与口服水合氯醛在小儿听觉脑干反应中的疗效:随机对照试验

Efficacy of Rectal Versus Oral Chloral Hydrate in Pediatric Auditory Brainstem Response: Randomized Controlled Trial.

作者信息

Siripermpool Chutaporn, Pattrakornkul Nalinee, Thongsattra Thanitda, Jianbunjongkit Narit

机构信息

Department of Pharmacy, Burapha University Hospital, Faculty of Medicine Burapha University Chonburi Thailand.

Department of Pediatrics, Faculty of Medicine Burapha University Chonburi Thailand.

出版信息

OTO Open. 2024 Sep 29;8(4):e70023. doi: 10.1002/oto2.70023. eCollection 2024 Oct-Dec.

Abstract

OBJECTIVE

To compare sedation success rates between rectal (RCH) and oral chloral hydrate (OCH) administration in children undergoing auditory brainstem response (ABR) testing and assess the incidence of adverse effects.

STUDY DESIGN

Randomized controlled trial, performed between May 2023 and August 2023.

SETTING

Ear, Nose, and Throat Outpatient Department at tertiary care hospital.

METHODS

Pediatric patients aged 1 to 5 years, who were indicated for ABR testing were enrolled and randomly divided into 2 groups. The control group received 10% wt/vol chloral hydrate orally at a dose of 50 mg/kg, while the other group received the same dose through rectal administration. Onset of sedation, duration of sedation, recovery time, vital signs, and adverse effects were recorded and analyzed to assess sedative effectiveness and safety.

RESULTS

Eighty-eight children were randomly assigned to RCH or OCH administration groups, the sedation success rates of RCH and OCH groups were 84.09% and 90.91%, respectively ( = .33). Adverse effects were detected in 11 children (12.5%), with a vomiting rate of 20.45% in the oral group versus 0% in the rectal group ( = .002). The diarrhea rate was 4.55% in the rectal group versus 0% in the oral group ( = .16). In either group, no serious adverse effects were documented.

CONCLUSION

RCH and OCH are both safe and effective for short-term sedation in pediatric patients during ABR testing. Interestingly, RCH administration offers a high success rate without vomiting or major adverse effects. This study established the effectiveness of RCH for sedation in children under specialized supervision.

摘要

目的

比较接受听性脑干反应(ABR)测试的儿童直肠给予水合氯醛(RCH)和口服水合氯醛(OCH)的镇静成功率,并评估不良反应的发生率。

研究设计

2023年5月至2023年8月进行的随机对照试验。

研究地点

三级护理医院的耳鼻喉科门诊。

方法

纳入1至5岁需进行ABR测试的儿科患者,并随机分为2组。对照组口服10%(重量/体积)水合氯醛,剂量为50mg/kg,而另一组通过直肠给药相同剂量。记录并分析镇静起效时间、镇静持续时间、恢复时间、生命体征和不良反应,以评估镇静效果和安全性。

结果

88名儿童被随机分配到RCH或OCH给药组,RCH组和OCH组的镇静成功率分别为84.09%和90.91%(P = 0.33)。11名儿童(12.5%)出现不良反应,口服组呕吐率为20.45%,直肠组为0%(P = 0.002)。直肠组腹泻率为4.55%,口服组为0%(P = 0.16)。两组均未记录到严重不良反应。

结论

RCH和OCH在儿科患者ABR测试期间进行短期镇静均安全有效。有趣的是,直肠给药成功率高,且无呕吐或重大不良反应。本研究证实了在专业监督下RCH用于儿童镇静的有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dcb/11439134/83c3ee0df436/OTO2-8-e70023-g002.jpg

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