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临床试验/NCT01701778
NCT01701778已完成2 期

Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Yao Yusheng1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年10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
发起方
入组人数
90
试验地点
1
主要终点
Time to first rescue medication

研究概览

简要总结

The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.

详细描述

Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.

Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of clonidine is the most beneficial remains unknown.

The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.

90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml normal saline intravenous.

研究设计

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

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • ASA status I-II
  • aged 2-5 yr
  • Undergoing unilateral orchiopexy/inguinal hernia repair

排除标准

  • Hypersensitivity to any local anesthetics
  • Patient has history of allergy, intolerance, or reaction to dexmedetomidine
  • Infections at puncture sites
  • Bleeding diathesis
  • Preexisting neurological disease
  • Diabetes mellitus
  • Children with uncorrected cardiac lesions
  • Children with heart block or liver impairment

研究组 & 干预措施

Placebo

Placebo Comparator

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

干预措施: sevoflurane (Drug)

Caudal Dexmedetomidine

Experimental

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

干预措施: Caudal Dexmedetomidine (Drug)

Caudal Dexmedetomidine

Experimental

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

干预措施: sevoflurane (Drug)

Intravenous Dexmedetomidine

Experimental

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Anesthesia was induced and maintained with sevoflurane

干预措施: Intravenous Dexmedetomidine (Drug)

Intravenous Dexmedetomidine

Experimental

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Anesthesia was induced and maintained with sevoflurane

干预措施: sevoflurane (Drug)

Placebo

Placebo Comparator

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

干预措施: Placebo (Drug)

结局指标

主要结局

Time to first rescue medication

时间窗: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h

the Children and Infants Postoperative Pain Scale (CHIPPS)

次要结局

  • the number of patients not requiring rescue analgesia(After surgery,up to 24h)
  • the sedation score(After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h)
  • Residual motor block(After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h)
  • the incidence of emergence agitation(Participants will be followed for the duration of PACU stay, an expected average of 2 hours)
  • side effects(From the administration of the caudal block until the end of study period, assessed up to postoperative 24h)
  • Pain intensity(after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h)

研究者

发起方
Yao Yusheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yao Yusheng

Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children

Fujian Provincial Hospital

研究点 (1)

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