Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

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

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).

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

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Gabapentin
• Placebo Comparator: 2
  • Placebo Comparator -- pill matched in appearance to gabapentin

Primary Measures

• Amount of Morphine Consumed (mg/kg/hr)
  • Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
    Safety Issue?: No
• Amount of Morphine Consumed (mg/kg/hr)
  • Time Frame: Day 1
    Safety Issue?: No
• Amount of Morphine Consumed (mg/kg/hr)
  • Time Frame: Day 2
    Safety Issue?: No

Secondary Measures

• Side Effect Occurrence
  • Time Frame: First 10 days after surgery
    Safety Issue?: No

Inclusion Criteria:

• ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

• ASA 3 or greater
• Neuromuscular scoliosis
• On narcotics baseline

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 9 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Medical College of Wisconsin Other

Overall Clinical Trial Officials and Contacts

Lynn M Rusy, MD Principal Investigator Medical College of Wisconsin  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00726999

Study ID Number: 06/71,GC 138

ClinicalTrials.gov Identifier: NCT00726999

Health Authority: United States: Food and Drug Administration