Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
Information source: Medical College of Wisconsin
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Gabapentin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Medical College of Wisconsin Official(s) and/or principal investigator(s):
Lynn M Rusy, MD, Principal Investigator, Affiliation: Medical College of Wisconsin
Lynn M Rusy, MD, Principal Investigator, Affiliation: Medical College of Wisconsin
Overall contact:
Lynn M Rusy, MD, Phone: 414-266-2507, Email: lrusy@mcw.edu
Summary
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)
Clinical Details
Official title: Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Amount of Opioid Sparing Effect of Gabapentin
Secondary outcome: Observe Opioid Side effects in relation to gabapentin, if decreases opioid need
Detailed description:
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
Eligibility
Minimum age: 9 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ASA 1-2, Idiopathic Scoliosis
Exclusion Criteria:
- ASA 3 or greater
- Neuromuscular scoliosis
- On narcotics baseline
Locations and Contacts
Lynn M Rusy, MD, Phone: 414-266-2507, Email: lrusy@mcw.edu
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Lynn M Rusy, MD, Phone: 414-266-2507, Email: lrusy@mcw.edu
Steve J Weisman, MD, Phone: 414-266-2775, Email: sweisman@chw.org
Lynn M Rusy, MD, Principal Investigator
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Active, not recruiting
Additional Information
Starting date: June 2006
Ending date: August 2008
Last updated: July 31, 2008
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