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临床试验/NCT02514980
NCT02514980已完成2 期

Infra-orbital Nerve Block for Post Operative Analgesia in Young Children Undergoing Pediatric Cleft Lip Surgery.

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
postoperative analgesic consumption

研究概览

简要总结

this study will be undertaken to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

详细描述

Oro-facial clefts are the most prevalent craniofacial birth defects and the second most common birth anomaly, second only to clubfoot [Strong & Buckmiller 2001]. Cleft lip surgery is associated with appreciable postoperative pain in children Alleviation of postoperative pain is important in these patients. The fear of respiratory depression using opioids has renewed the interest in regional anesthesia to provide safe and effective postoperative analgesia. Infra-orbital nerve block has been advocated as a suitable local analgesic technique for cleft lip surgery and superficial surgery on the mid face [Morton 2004, Takmaz et al. 2009, Rajesh et al. 2011, Jindal et al. 2011].The infra-orbital nerve supplies the upper lip, lower eyelid, and adjacent skin of the cheek and nose. Unilateral or bilateral infra-orbital nerve block has been performed with a very high success rate.

The investigators designed this study to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • (ASA) physical status I and II aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia.

排除标准

  • Patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.

研究组 & 干预措施

Bupivacaine group

Active Comparator

Infraorbital nerve block using bupivacaine 0.25% on each side.

干预措施: Bupivacaine (Drug)

Bupivacaine-Ketamine group.

Active Comparator

Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.

干预措施: Bupivacaine (Drug)

Bupivacaine-Ketamine group.

Active Comparator

Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.

干预措施: Ketamine (Drug)

结局指标

主要结局

postoperative analgesic consumption

时间窗: 24 hours postoperative

the total consumption of analgesics in the first 24h postoperative

次要结局

  • Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score(24 h postoperative.)
  • Parent satisfaction score(24 h postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hala Saad Abdel-Ghaffar

MD

Assiut University

研究点 (1)

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