Recruiting
Phase 2
Phase 3

Gabapentin

Sponsor:

UCLA

Code:

NCT04724252

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Gabapentin

Placebo

Study Details

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

Study ID

NCT04724252

Start date

Aug 23, 2021

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Gabapentin Treatment

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.

placebo comparator: Control Group

Given placebo which coincides with the active treatment group

Interventions

Gabapentin

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

Placebo

Control Arm

Primary outcome measure

  • Amount of pain medication needed. [ Time Frame: 7 days post-operative or until discharge, whichever came first ]

Central Contacts and Locations

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Michaela Canova, BA

916-734-1202mecanova@health.ucdavis.edu

Daniel Neyshloss, BS

916-734-1202dbneyshloss@health.ucdavis.edu

Principal Investigator:

Gary Raff, MD

More Information

Sponsor

University of California, Davis

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • thoracic surgery
  • cardiac surgery via a sternotomy or thoracotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-10-31.