跳至主要内容
临床试验/CTRI/2025/12/098597
CTRI/2025/12/098597招募中不适用

A randomized controlled trial to assess the efficacy of clonidine as an adjunct to suprazygomatic maxillary nerve blocks for pediatric cleft lip and palate surgeries.

Childrens Anaesthesia Services Mumbai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月23日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
To get the percentage of patients requiring supplemental analgesia (rescue dose) within 4 hours postoperatively using the FLACC score.

研究概览

简要总结

Suprazygomatic maxillary nerve block SZMNB was used for analgesia in pediatric cleft palate surgery 1 The use of bilateral SZMNB has in a previous study been reported to reduce the need of intraoperative fentanyl and volatile agent 2 but did not report on postoperative pain We have planned this study to evaluate the effectiveness of clonidine as an adjunct to suprazygomatic approach maxillary nerve block for pediatric patients undergoing cleft lip and palate surgeries

Eligible patients will be screened and informed written consent will be obtained from parents or caregivers before participation Randomization will be performed using computer generated random numbers or sealed envelopes Participants will be allocated to one of two study groups

The clonidine group will receive 2 mcgkg of clonidine added to 025 percent levobupivacaine administered at a volume of 015 mLkg per side The placebo group will receive the same volume of saline added to 025 percent levobupivacaine

The study will terminate at 24 hours postoperatively with follow up on Day 5 for wound healing assessments

References 1 Mesnil M Dadure C Captier G Raux O Rochette A Canaud N Sauter M Capdevila X A new approach for peri operative analgesia of cleft palate repair in infants the bilateral suprazygomatic maxillary nerve block Paediatr Anaesth 2010 20 3439 2 Chiono J Raux O Bringuier S Sola C Bigorre M Capdevila X Dadure C Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children a prospective randomized double blind study versus placebo Anesthesiology 2014 120 13629

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • ASA 1/2 with Cleft palate and/lip.

排除标准

  • ASA 3 /4 with other malformations.

结局指标

主要结局

To get the percentage of patients requiring supplemental analgesia (rescue dose) within 4 hours postoperatively using the FLACC score.

时间窗: 4 hours

次要结局

  • Pain scores 0-24 h (Pain scale (FLACC), food intake during 12-24 hours postop, Duration of sleep5, and sedation scores during postop period, complications like POV, bradycardia, emergence delirium etc., Length of hospital stay (24 hours to 48 hours or more), Wound healing on the 5 th day: A: excellent. b: satisfatctory. c: Poor.(24 hours)

研究者

发起方
Childrens Anaesthesia Services Mumbai
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Vrushali C Ponde

Holy Spirit Hospital, Mumbai

研究点 (1)

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