NCT03867240

Gabapentin and Chronic Post Surgical Pain

The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pain, Postoperative
• Scoliosis Idiopathic

Interventions

Type	Name	Description
DRUG	Gabapentin	Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients \<50 kg and 200 mg for patients \> 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
OTHER	Placebo	Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, 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. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-03-07
• Last updated: 2021-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study