Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients|
- Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) ] [ Designated as safety issue: No ]Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.
- Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
- Side Effect Occurrence [ Time Frame: First 10 days after surgery ] [ Designated as safety issue: No ]The number of episodes of/occurrence of side effects was monitored in both groups.
|Study Start Date:||June 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
Other Name: NeurontinDrug: Morphine
Administered as needed
Placebo Comparator: 2
Placebo Comparator -- pill matched in appearance to gabapentin
Administered as needed
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726999
|Principal Investigator:||Lynn M Rusy, MD||Medical College of Wisconsin|