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RecruitingPhase 2Phase 3NCT04724252

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Sponsor

University of California, Davis

Enrollment

60 participants

Start Date

Aug 23, 2021

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative

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

Max Age: 17 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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

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Interventions

DRUGGabapentin

Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.

OTHERPlacebo

Control Arm

Locations(1)

UC Davis Medical Center

Sacramento, California, United States

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NCT04724252

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