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

Blinded study using oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge, PCA morphine and placebo group with similar pills, also PCA morphine.

Measure narcotic requirements, incidence of narcotic side effects (puritis, days foley, days to first stool, sedation, pain scores, PCA use)

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Healthy, 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Gabapentin
• No Intervention: 2
  • Placebo Comparator

Primary Measures

• Amount of Opioid Sparing Effect of Gabapentin
  • Time Frame: First 5 days after surgery
    Safety Issue?: No

Secondary Measures

• Observe Opioid Side effects in relation to gabapentin, if decreases opioid need
  • 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 Sponsor: Medical College of Wisconsin

Overall Clinical Trial Officials and Contacts

Lynn M Rusy, MD Principal Investigator Medical College of Wisconsin  

Information obtained from ClinicalTrials.gov on July 02, 2009

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