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How Does Gabapentin Affects Post-operative Tonsillectomy Pain?

NCT00624455 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-08-18

No results posted yet for this study

Summary

Gabapentin is a medicine that has been used in adults (but not yet in children) to treat pain after surgery. In children it has been used for many years to treat other conditions and has been shown to be very safe.

Removal of tonsils is a common operation with each child experiencing a similar pattern of pain; this makes it good for looking at the effect of pain relieving medicines. In our study each child will get the same operation and medicines, as they would have normally. Before the operation and in a random way, half will get gabapentin and half will get the same syrup but with no gabapentin. Afterwards we will record how much pain the children have and how much of our standard medicine is needed to make them comfortable. We expect both of these results to be lower in the half who received gabapentin. We will also record the amount and type of unwanted effects, both from the gabapentin and from any other pain relief medicines.

Conditions

  • Post-operative Pain

Interventions

DRUG

Gabapentin

One dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Robert Purdy, MD · University of British Columbia

  • Mark Ansermino, MD · University of British Columbia

  • Andrew Morrison, MD · University of British Columbia

  • Helen Hume-Smith, MD · University of British Columbia

  • Simon Whyte, MD · University of British Columbia

  • Carolyne Montgomery, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2009-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624455 on ClinicalTrials.gov