Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
研究概览
简要总结
This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >=18 years-old
- •Presenting for a surgical abortion
- •No contraindication to outpatient abortion
- •No contraindication to gabapentin
- •Fluency in English and able to provide informed consent
排除标准
- •Allergy, sensitivity or contraindication to gabapentin
- •Severe renal disease
- •Currently using gabapentin or pregalabin
研究组 & 干预措施
Group 1: Placebo
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
干预措施: Placebo (Drug)
Group 2: Gabapentin
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
时间窗: 5 minutes
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
次要结局
- Number of Subjects Experiencing Perioperative Vomiting(Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes)
- Side Effects (on a 5-point Scale)(Post-operative day 1)
- Perioperative Anxiety as Measured by the 100-mm VAS(5 minutes, 10 minutes, 30 minutes, discharge)
- Number of Subjects Using Pain Medications(24 hours post-operatively)
- Nausea (on a 5-point Scale)(Post-operative day 1)
- Pain Score on the 100-mm VAS(Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute)
- Perioperative Nausea as Measured by 100-mm VAS(Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes)
- Number of Subjects Experiencing Side Effects(10 minutes post-procedure)
- Pain (on a 5-point Scale)(Post-operative day 1)
- Vomiting (on a 5-point Scale)(Post-operative day 1)
- General Satisfaction With the Procedure (on a 5-point Scale)(Post-operative day 1)