Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

June 12, 2023 updated by: University of California, Davis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Principal Investigator:
          • Gary Raff, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.
  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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gabapentin Treatment
Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose.
Drug: Gabapentin
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
Placebo Comparator: Control Group
Given placebo which coincides with the active treatment group
Other: Placebo
Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of pain medication needed.
Time Frame: 7 days post-operative or until discharge, whichever came first
Amount of pain medication needed after surgery
7 days post-operative or until discharge, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1571754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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