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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring thoracic surgery, cardiac surgery via a sternotomy or thoracotomy

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin Treatment

Control Group

Arm Description

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.

Given placebo which coincides with the active treatment group

Outcomes

Primary Outcome Measures

Amount of pain medication needed.
Amount of pain medication needed after surgery

Secondary Outcome Measures

Full Information

First Posted
January 21, 2021
Last Updated
June 12, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04724252
Brief Title
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Official Title
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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
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: opioid use based of IV morphine pain scores opioid related complications such as withdrawal effects on the level of sedation Possible adverse effects associated with use of gabapentin 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
thoracic surgery, cardiac surgery via a sternotomy or thoracotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Children meeting criteria will be randomized in a 1:1 ratio using 4 blocked randomization to either gabapentin or placebo (in addition to standard of care pain control treatment):
Masking
ParticipantInvestigator
Masking Description
This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Given placebo which coincides with the active treatment group
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Control Arm
Primary Outcome Measure Information:
Title
Amount of pain medication needed.
Description
Amount of pain medication needed after surgery
Time Frame
7 days post-operative or until discharge, whichever came first

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age newborn to < 18 years. Gestational age to be minimum 38 weeks. Undergo cardiac surgery via a sternotomy or thoracotomy. Any Thoracic Surgery 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. Participation in another clinical study presently or within the last 30 days Pregnancy Prisoners
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Falwell, BSN
Phone
916-453-2134
Email
kafalwell@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Michaela Canova, BS
Phone
916-453-2124
Email
mecanova@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Gary Raff, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://studypages.com/s/a-study-of-gabapentin-to-reduce-opioid-use-after-surgery-in-children-the-group-study-210128/
Description
Learn more or sign up for the study here!

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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

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