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临床试验/ISRCTN42842643
ISRCTN42842643已完成未知

How effective is Ametop 4% gel, before a venipuncture, at reducing procedural pain in infants: a randomized placebo-controlled trial

Children's Hospital of Eastern Ontario Research Institute (Canada)0 个研究点目标入组 142 人开始时间: 2005年11月4日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
142

研究概览

简要总结

2007 Results article in https://pubmed.ncbi.nlm.nih.gov/17288611/ (added 27/10/2022)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Born at >24 weeks gestation
  • 2. Skin considered in good condition (no burns or rash)
  • 3. If <27 weeks gestation, at least 48 hours of life
  • 4. Considered stable by the treating neonatologist

排除标准

  • 1. Skin considered immature (insensible water losses requiring more fluids than usual for gestation)
  • 2. Suspected or proven significant central nervous system anomaly
  • 3. Receiving opioids or sedatives at time of venipuncture or in the previous 12 hours or receiving muscle relaxants
  • 4. Facial anomalies (cleft lip/palate, Moebius syndrome) preventing typical facial expression of pain
  • 5. Sub optimal hepatic function (alanine aminotransferase [ALT] >2 x upper normal limit) or sub optimal renal function (urine output <1 ml/kg/hour in the last 12 hours)

研究者

发起方
Children's Hospital of Eastern Ontario Research Institute (Canada)

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