Gabapentin and Chronic Post Surgical Pain

Phase 3

Withdrawn

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Gabapentin	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.

Primary Outcome Measures

Name	Time	Method
Change in NRS for pain intensity score comparing gabapentin and placebo groups	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	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).

Secondary Outcome Measures

Name	Time	Method
Time to ambulation in patients receiving gabapentin versus placebo	Postoperative period up to 1 month	Time to ambulation will be recorded.
First oral intake in patients receiving gabapentin versus placebo	Postoperative period up to 1 month	Time to first oral intake will be recorded.
Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo	Postoperative period up to 1 month	Opioid consumption will be tabulated from the postoperative care unit (PACU), across nursing shifts and cumulative amounts per day. IV morphine will be converted to oral morphine equivalents using a 3:1 ratio or IV hydromorphone will be converted to IV morphine using a 5:1 ratio. Oxycodone will be converted to oral morphine equivalents using a 1:1.5 ratio. All cumulative opioids will be reported as oral morphine equivalents.
Time to discharge in each group in patients receiving gabapentin versus standard of care	Postoperative period up to 1 month	Time to discharge will be recorded.

Locations (1): Children's Healthcare of Atlanta
🇺🇸
Atlanta, Georgia, United States