Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages Any age to 17

Using gabapentin to reduce opioid use in children after thoracic surgery

Official title: Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Run by University of California, Davis · NCT04724252 · Data updated 2026-11-12

This study is testing if gabapentin can help reduce the amount of pain medication kids need after having thoracic surgery.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
AgesAny age to 17 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of California, Davis
Academic / other
Locations1 site (Sacramento, California)
StatusRecruiting
StartedAugust 23, 2021
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedOctober 26, 2026
Trial IDNCT04724252 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged newborn to under 18 years undergoing thoracic surgery with an expected inpatient stay of at least 48 hours.

Probably not a fit

Patients with a history of seizures, chronic pain, or recent opioid use may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of gabapentin in reducing the need for narcotics in children undergoing thoracic surgery. It is a double-blind, placebo-controlled, randomized study involving 60 subjects who will be assigned to either a gabapentin treatment group or a placebo control group. The study aims to assess various outcomes, including opioid use, pain scores, and potential complications related to opioid use and gabapentin. Participants will be monitored for 7 days or until discharge from the hospital.

Why it matters

Potential benefit: If successful, this study could significantly reduce opioid consumption in pediatric patients post-surgery, leading to improved recovery and fewer opioid-related complications.

How similar studies have gone: Other studies have shown promising results with gabapentin in reducing opioid use, suggesting this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • UC Davis Medical Center
    Sacramento, California, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.