Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 63
- Primary Endpoint
- Amount of Morphine Consumed (mg/kg/hr)
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA 1-2, Idiopathic Scoliosis
Exclusion Criteria
- •ASA 3 or greater
- •Neuromuscular scoliosis
- •On narcotics baseline
Arms & Interventions
2
Placebo Comparator -- pill matched in appearance to gabapentin
Intervention: Placebo (Drug)
1
Gabapentin
Intervention: Gabapentin (Drug)
1
Gabapentin
Intervention: Morphine (Drug)
2
Placebo Comparator -- pill matched in appearance to gabapentin
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
Amount of Morphine Consumed (mg/kg/hr)
Time Frame: Day 2
Secondary Outcomes
- Number of Ondansetron Doses Administered for Nausea(First 10 days after surgery)
Investigators
Lynn Rusy
Professor of Anesthesiology
Medical College of Wisconsin