Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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):

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

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

Control Group

Given placebo which coincides with the active treatment group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Control Arm

Interventions

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Gabapentin

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

Intervention Type DRUG

Placebo

Control Arm

Intervention Type OTHER

Eligibility Criteria

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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

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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No