How Does Gabapentin Affects Post-operative Tonsillectomy Pain?

NCT00624455 | Completed Phase 3

• 1 other identifier: H07-00265
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gabapentin; tonsillectomy; post-operative pain; morphine requirements; randomized double blind; adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• Total postoperative morphine consumption at four hours (from the time of extubation)

  4 hours

Secondary Outcomes (1)

• Pain scores, presence of nausea/ vomiting, dizziness, sedation, satisfaction

  4 hours

Study Arms (2)

1

ACTIVE COMPARATOR

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: Gabapentin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Gabapentin DRUG

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.

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Tonsillectomy
• Adenotonsillectomy
• ASA status 1 to 3
• Weight \< 60 kg
• BMI \< 30

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Robert Purdy, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mark Ansermino, MD

  University of British Columbia

  STUDY DIRECTOR

• Andrew Morrison, MD

  University of British Columbia

  STUDY DIRECTOR

• Helen Hume-Smith, MD

  University of British Columbia

  STUDY DIRECTOR

• Simon Whyte, MD

  University of British Columbia

  STUDY DIRECTOR

• Carolyne Montgomery, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 27, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: August 18, 2009

Record last verified: 2009-08

Locations

CA (1)