Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Narcotic Consumption
研究概览
简要总结
The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.
详细描述
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As from a regional healthcare organization. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively. Additionally, young children will receive instruction for Tylenol and Motrin postoperatively while teenagers will receive a narcotic prescription. Outcome measurements include: mean Tylenol mg/kg, Motrin mg/kg and narcotic mg/kg use. Additional measurements: Mean time to first analgesic. Phone interviews with the research nurse for three days postoperatively will elicit pain scores at 12, 24 and 48 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants age 3-18 years
- •ASA class 1 or 2
- •elective Tonsillectomy/Adenoidectomy
- •outpatient setting.
排除标准
- •BMI >40kg/m2
- •history of renal insufficiency, chronic pain
- •allergy to gabapentin
- •history of developmental delay
研究组 & 干预措施
Placebo Group
Participants will be randomized to either Control Group or Gabapentin Group
干预措施: Gabapentin (Drug)
Gabapentin Group
Participants will be randomized to either Control Group or Gabapentin Group
干预措施: Gabapentin (Drug)
结局指标
主要结局
Narcotic Consumption
时间窗: First 48 hours postoperatively
To examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg(weight and height will be combined to report BMI in kg/m\^2).
次要结局
- First Analgesic Timing(First 48 Hours postoperatively)
- Pain Scale Scores(12, 24 and 48 hours postoperatively.)
研究者
Margaret Gettis
Nurse Scientist
Children's Healthcare of Atlanta