Summary

Eligibility
for people ages up to 17 years (full criteria)
Location
at Sacramento, California
Dates
study started
estimated completion
Principal Investigator
by Gary Raff, MD

Description

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

Official Title

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Details

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.

Keywords

Pain, Postoperative thoracic surgery cardiac surgery via a sternotomy or thoracotomy Gabapentin

Eligibility

You can join if…

Open to people ages up to 17 years

  1. Age newborn to < 18 years.
  2. Gestational age to be minimum 38 weeks.
  3. Undergo cardiac surgery via a sternotomy or thoracotomy.
  4. Any Thoracic Surgery
  5. Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
  6. Surgery will result in an inpatient stay of at least 48 hours.

You CAN'T join if...

  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

Location

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Gary Raff, MD
    Professor, Surgery. Authored (or co-authored) 50 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT04724252
Phase
Phase 2/3
Study Type
Interventional
Last Updated