NCT04724252 Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
| NCT ID | NCT04724252 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of California, Davis |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-08-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2021-08-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Frequently Asked Questions
Who can join the NCT04724252 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04724252 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04724252 currently recruiting?
Yes, NCT04724252 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, Davis to inquire about joining.
Where is the NCT04724252 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT04724252 clinical trial?
NCT04724252 is sponsored by University of California, Davis. The trial plans to enroll 60 participants.