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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Status | Recruiting |
| Started | August 23, 2021 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT04724252 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.