The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in NRS for pain intensity score comparing gabapentin and placebo groups
研究概览
简要总结
The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.
详细描述
Pain after surgery can last for a long time. When it lasts for over two months, it is considered chronic postsurgical pain (CPSP). This is a problem in kids and adolescents that can impact many areas of the patient's life and their family. Many patients who undergo surgery for their scoliosis develop CPSP. The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 10-18 years at the time of surgery
- •Have a diagnosis of idiopathic scoliosis and/or kyphosis
- •Be undergoing elective posterior spinal fusion
- •Have only mild systemic disease
排除标准
- •A diagnosis of neuromuscular scoliosis and/or kyphosis
- •A diagnosis of chronic pain
- •Used opioids in the past 6 months
- •Developmental delay
- •Liver or kidney disease
- •Obstructive sleep apnea
- •Body mass index >40
- •Be pregnant or breastfeeding
研究组 & 干预措施
Gabapentin
Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.
干预措施: Gabapentin (Drug)
Placebo
Control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group.
干预措施: Placebo (Other)
结局指标
主要结局
Change in NRS for pain intensity score comparing gabapentin and placebo groups
时间窗: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
Patient's included in the study will rate their current pain using the numerical rating scale (NRS). With the NRS for pain intensity, the child rates their pain on a zero to 10 Likert scale, with zero being no pain and 10 being the most pain imaginable. A NRS \> 4/10 at the time of the survey will be considered positive for CPSP.
Change in FDI score comparing gabapentin and placebo groups
时间窗: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
The functional disability inventory (FDI) is a 15 question self-report inventory that assesses the impact of daily pain on activities at home, school, recreational and social domains. Items are rated on a five-point Likert Scale, ranging from 0 to 4, representing no trouble with the activity up to impossible to do the activity. The scores are tabulated, classifying the patient's function as no to minimal disability (0-12), moderate disability (12-29) or severe disability (30-60).
次要结局
- Time to ambulation in patients receiving gabapentin versus placebo(Postoperative period up to 1 month)
- First oral intake in patients receiving gabapentin versus placebo(Postoperative period up to 1 month)
- Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo(Postoperative period up to 1 month)
- Time to discharge in each group in patients receiving gabapentin versus standard of care(Postoperative period up to 1 month)
研究者
Cheryl Hartzell
Assistant Professor
Emory University