Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Study Overview
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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

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: 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.

Official Title
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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age newborn to < 18 years. Gestational age to be minimum 38 weeks. Undergo cardiac surgery via a sternotomy or thoracotomy. Any Thoracic Surgery 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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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):
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin Treatment<br>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<br>* Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.<br>|
| Placebo Comparator: Control Group<br>Given placebo which coincides with the active treatment group | Other: Placebo<br>* Control Arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic surgery, cardiac surgery via a sternotomy or thoracotomy