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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

RecruitingPhase 2, Phase 3Ages any - 17 YearsAllUniversity of California, Davis
NCT04724252 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Gabapentin
  • Placebo
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Where

1 site
UC Davis Medical Center
Sacramento, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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