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RecruitingNCT04724252Updated Oct 31, 2025

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

A Phase 2/3 interventional study of Gabapentin and Placebo in Pain, Postoperative, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-10-31.

Sponsored by University of California, Davis · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2021; still recruiting 5 years 1 month later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • thoracic surgery
  • cardiac surgery via a sternotomy or thoracotomy
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Control Group

    Given placebo which coincides with the active treatment group

    Other: Placebo

Interventions

  • DrugGabapentin

    Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.

  • OtherPlacebo

    Control Arm

06

What researchers measure

Primary outcomes

  1. Amount of pain medication needed.

    Amount of pain medication needed after surgery

    Time frame: 7 days post-operative or until discharge, whichever came first

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04724252
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Jan 26, 2021
Start date
Aug 23, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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