RecruitingPhase 2/3

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

United States60 participantsStarted 2021-08-23

Plain-language 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

Who can participate

Age range17 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Amount of pain medication needed.

Timeframe: 7 days post-operative or until discharge, whichever came first

Trial details

NCT IDNCT04724252

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Pain, Postoperative trials