Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion - Full Text View

Sponsor:	Medical College of Wisconsin
Collaborator:	Children's Hospital Wisconsin - Pain and Paliative Care Center
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00726999

Purpose

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)

Condition	Intervention
Postoperative Pain	Drug: Gabapentin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

Resource links provided by NLM:

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

Amount of Opioid Sparing Effect of Gabapentin [ Time Frame: First 5 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Observe Opioid Side effects in relation to gabapentin, if decreases opioid need [ Time Frame: First 10 days after surgery ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	June 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Gabapentin	Drug: Gabapentin oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
2: No Intervention Placebo Comparator

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

Ages Eligible for Study:	9 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

ASA 3 or greater
Neuromuscular scoliosis
On narcotics baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726999

Locations

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Children's Hospital Wisconsin - Pain and Paliative Care Center

Investigators

Principal Investigator:	Lynn M Rusy, MD	Medical College of Wisconsin
Principal Investigator:	Lynn M Rusy, MD	Medical College of Wisconsin

More Information

No publications provided

Responsible Party:	Medical College of Wisconsin Anesthesia Department ( Dr. Lynn M. Rusy )
Study ID Numbers:	06/71,GC 138, IND #74,317
Study First Received:	July 30, 2008
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00726999 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:

Gabapentin
Pediatric Spinal Fusion
Narcotic Use

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Pain
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses

Analgesics
Pain, Postoperative
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Postoperative Complications
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010