Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00726999
First received: July 30, 2008
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

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).


Condition Intervention
Postoperative Pain
Drug: Gabapentin
Drug: Placebo
Drug: Morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) ] [ Designated as safety issue: No ]
    Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.

  • Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side Effect Occurrence [ Time Frame: First 10 days after surgery ] [ Designated as safety issue: No ]
    The number of episodes of/occurrence of side effects was monitored in both groups.


Enrollment: 63
Study Start Date: June 2006
Study Completion Date: May 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gabapentin
Drug: Gabapentin
oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
Other Name: Neurontin
Drug: Morphine
Administered as needed
Placebo Comparator: 2
Placebo Comparator -- pill matched in appearance to gabapentin
Drug: Placebo Drug: Morphine
Administered as needed

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Lynn M Rusy, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Dr. Lynn M. Rusy, Medical College of Wisconsin Anesthesia Department
ClinicalTrials.gov Identifier: NCT00726999     History of Changes
Other Study ID Numbers: 06/71,GC 138
Study First Received: July 30, 2008
Results First Received: August 19, 2010
Last Updated: January 3, 2011
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:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014