Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Phase 2

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Other: Placebo; Drug: Gabapentin

• Registration Number: NCT04724252
• Lead Sponsor: University of California, Davis

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:

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 Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Study Start: 2021-08-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Given placebo which coincides with the active treatment group
Gabapentin Treatment	Gabapentin	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States