Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726999
• Other study ID #: 06/71,GC 138
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: May 2009

Study information

• Verified date: March 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

• ASA 3 or greater

• Neuromuscular scoliosis

• On narcotics baseline

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

• Morphine
Administered as needed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
Primary	Amount of Morphine Consumed (mg/kg/hr)		Day 1
Primary	Amount of Morphine Consumed (mg/kg/hr)		Day 2
Secondary	Number of Ondansetron Doses Administered for Nausea	The number of doses of Ondansetron given for nausea to participants in both groups.	First 10 days after surgery