Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of pain medication needed.
研究概览
简要总结
The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery.
We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin
详细描述
This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment.
60 subjects will be randomized in a 1:1 ratio to either:
- Gabapentin treatment group
- Placebo - control group
We aim to understand the impact that gabapentin use peri and post operatively has on:
- opioid use based of IV morphine
- pain scores
- opioid related complications such as withdrawal
- effects on the level of sedation
- Possible adverse effects associated with use of gabapentin
- Time to extubating
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
- Double (Participant, Investigator)
盲法说明
This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age newborn to < 18 years.
- •Gestational age to be minimum 38 weeks.
- •Undergo cardiac surgery via a sternotomy or thoracotomy. OR Any Thoracic Surgery OR Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
- •Surgery will result in an inpatient stay of at least 48 hours.
排除标准
- •Use of opioids within 30 days prior to study entry.
- •Renal Failure as defined by RIFLE Criteria.
- •History of seizures requiring active treatment.
- •History of chronic pain treated medically.
- •Diagnosis of Autism.
- •Unable to tolerate enteral medications.
- •Hematology/Oncology patients.
- •Parents/legal guardians unable to consent.
- •Participation in another clinical study presently or within the last 30 days
- •Patient undergoing nuss procedure with cryoablation
研究组 & 干预措施
Gabapentin Treatment
Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose.
干预措施: Gabapentin (Drug)
Control Group
Given placebo which coincides with the active treatment group
干预措施: Placebo (Other)
结局指标
主要结局
Amount of pain medication needed.
时间窗: 7 days post-operative or until discharge, whichever came first
Amount of pain medication needed after surgery
次要结局
未报告次要终点