Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Study Overview
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Brief Summary
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Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).

Detailed Description
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Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion. Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine No remifentanil, clonidine, ketamine N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08

Official Title
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Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-2, Idiopathic Scoliosis Exclusion Criteria: ASA 3 or greater Neuromuscular scoliosis On narcotics baseline

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gabapentin | Drug: Gabapentin<br>* oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge<br>* Other names: Neurontin;Drug: Morphine<br>* Administered as needed<br>|
| Placebo Comparator: 2<br>Placebo Comparator -- pill matched in appearance to gabapentin | Drug: Placebo<br> <br> Drug: Morphine<br>* Administered as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Morphine Consumed (mg/kg/hr) | Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour. | PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) | 
| Amount of Morphine Consumed (mg/kg/hr) |  | Day 1 | 
| Amount of Morphine Consumed (mg/kg/hr) |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Ondansetron Doses Administered for Nausea | The number of doses of Ondansetron given for nausea to participants in both groups. | First 10 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, Pediatric Spinal Fusion, Narcotic Use