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NCT Number: NCT04724252

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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

Placebo

Other

Control Arm

Primary outcomes

  1. Amount of pain medication needed.

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

    Amount of pain medication needed after surgery

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2021
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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