Gabapentin to Reduce Opioid Use Postoperatively (GROUP) i... | NCT04724252

Studies
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

NCT04724252

Sponsor

University of California, Davis

Status

Recruiting

Last Update Posted

Oct 31, 2025Actual

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Pain, Postoperative

Interventions

Gabapentin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 23, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Jan 25, 2021

First Posted Date

Jan 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2025

Last Update Posted Date

Oct 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin Treatment	Active Comparator	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
Control Group	Placebo Comparator	Given placebo which coincides with the active treatment group	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.	Gabapentin Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 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
Patient undergoing nuss procedure with cryoablation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center	Recruiting	Sacramento	California	95817	United States

Label	URL
Learn more or sign up for the study here!	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided