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Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Gabapentin

Placebo

Morphine

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Gabapentin, Pediatric Spinal Fusion, Narcotic Use

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

ASA 3 or greater
Neuromuscular scoliosis
On narcotics baseline

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Gabapentin

Placebo Comparator -- pill matched in appearance to gabapentin

Outcomes

Primary Outcome Measures

Amount of Morphine Consumed (mg/kg/hr)

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)

Secondary Outcome Measures

Number of Ondansetron Doses Administered for Nausea

The number of doses of Ondansetron given for nausea to participants in both groups.

Full Information

NCT ID

NCT00726999

First Posted

July 30, 2008

Last Updated

March 21, 2019

Sponsor

Medical College of Wisconsin

Collaborators

Children's Hospital and Health System Foundation, Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT00726999

Brief Title

Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Official Title

Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

Collaborators

Children's Hospital and Health System Foundation, Wisconsin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Gabapentin, Pediatric Spinal Fusion, Narcotic Use

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Gabapentin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo Comparator -- pill matched in appearance to gabapentin

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

Neurontin

Intervention Description

oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Description

Administered as needed

Primary Outcome Measure Information:

Title

Amount of Morphine Consumed (mg/kg/hr)

Description

Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.

Time Frame

PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)

Title

Amount of Morphine Consumed (mg/kg/hr)

Time Frame

Day 1

Title

Amount of Morphine Consumed (mg/kg/hr)

Time Frame

Day 2

Secondary Outcome Measure Information:

Title

Number of Ondansetron Doses Administered for Nausea

Description

The number of doses of Ondansetron given for nausea to participants in both groups.

Time Frame

First 10 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA 1-2, Idiopathic Scoliosis Exclusion Criteria: ASA 3 or greater Neuromuscular scoliosis On narcotics baseline

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lynn M Rusy, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

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