NCT00726999

Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Gabapentin	oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
DRUG	Placebo
DRUG	Morphine	Administered as needed

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-07-01
• Completion: 2009-05-01
• First posted: 2008-08-01
• Last updated: 2019-04-03
• Results posted: 2010-12-30