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Gabapentin and Chronic Post Surgical Pain

NCT03867240 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-02-08

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Scoliosis Idiopathic

Interventions

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Cheryl Hartzell, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867240 on ClinicalTrials.gov