Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

NCT04724252 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 1571754
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain, Postoperative

Keywords

thoracic surgery; cardiac surgery via a sternotomy or thoracotomy

Outcome Measures

Primary Outcomes (1)

• Amount of pain medication needed.

  Amount of pain medication needed after surgery

  7 days post-operative or until discharge, whichever came first

Study Arms (2)

Gabapentin Treatment

ACTIVE COMPARATOR

Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose.

Drug: Gabapentin

Control Group

PLACEBO COMPARATOR

Given placebo which coincides with the active treatment group

Other: Placebo

Interventions

Gabapentin DRUG

Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.

Gabapentin Treatment

Placebo OTHER

Control Arm

Control Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age newborn to \< 18 years.
• Gestational age to be minimum 38 weeks.
• Undergo cardiac surgery via a sternotomy or thoracotomy. OR Any Thoracic Surgery OR Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
• Surgery will result in an inpatient stay of at least 48 hours.

You may not qualify if:

• Use of opioids within 30 days prior to study entry.
• Renal Failure as defined by RIFLE Criteria.
• History of seizures requiring active treatment.
• History of chronic pain treated medically.
• Diagnosis of Autism.
• Unable to tolerate enteral medications.
• Hematology/Oncology patients.
• Parents/legal guardians unable to consent.
• Participation in another clinical study presently or within the last 30 days
• Pregnancy
• Prisoners
• Patient undergoing nuss procedure with cryoablation

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children meeting criteria will be randomized in a 1:1 ratio using 4 blocked randomization to either gabapentin or placebo (in addition to standard of care pain control treatment):

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: August 23, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)