Status:
RECRUITING
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Lead Sponsor:
University of California, Davis
Conditions:
Pain, Postoperative
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
PHASE3
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 wh...
Detailed Description
This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment. 60 subjects...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04724252
Start Date
August 23 2021
End Date
December 31 2026
Last Update
October 31 2025
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817