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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Recruiting
17 years and younger
All
Phase 2/3

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Overview

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

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 will be randomized in a 1:1 ratio to either:

  • Gabapentin treatment group
  • Placebo - control group

We aim to understand the impact that gabapentin use peri and post operatively has on:

  1. opioid use based of IV morphine
  2. pain scores
  3. opioid related complications such as withdrawal
  4. effects on the level of sedation
  5. Possible adverse effects associated with use of gabapentin
  6. Time to extubating

The duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from UC Davis Hospital, whichever occurs first.

Eligibility

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

Study details
    Pain
    Postoperative

NCT04724252

University of California, Davis

1 November 2025

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FAQs

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