NCT04724252

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery. We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin

Detailed description

This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment. 60 subjects will be randomized in a 1:1 ratio to either: * Gabapentin treatment group * Placebo - control group We aim to understand the impact that gabapentin use peri and post operatively has on: 1. opioid use based of IV morphine 2. pain scores 3. opioid related complications such as withdrawal 4. effects on the level of sedation 5. Possible adverse effects associated with use of gabapentin 6. Time to extubating The duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from UC Davis Hospital, whichever occurs first.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Gabapentin	Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
OTHER	Placebo	Control Arm

Timeline

• Start date: 2021-08-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-01-26
• Last updated: 2025-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study