How Does Gabapentin Affects Post-Operative Tonsillectomy Pain?
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Operative Pain
Intervention: Gabapentin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Robert Purdy, MD, Principal Investigator, Affiliation: University of British Columbia
Mark Ansermino, MD, Study Director, Affiliation: University of British Columbia
Andrew Morrison, MD, Study Director, Affiliation: University of British Columbia
Helen Hume-Smith, MD, Study Director, Affiliation: University of British Columbia
Simon Whyte, MD, Study Director, Affiliation: University of British Columbia
Carolyne Montgomery, MD, Principal Investigator, Affiliation: University of British Columbia
Overall contact:
Joanne Lim, Phone: 604-875-2000, Ext: 6669, Email: jlim2@cw.bc.ca
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.
Clinical Details
Official title: Does a Single Preoperative Dose of Gabapentin Reduce Postoperative Tonsillectomy Pain and Subsequent Morphine Requirement in Children?
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: Total postoperative morphine consumption at four hours (from the time of extubation)
Secondary outcome: Pain scores, presence of nausea/ vomiting, dizziness, sedation, satisfaction
Detailed description:
Tonsillectomy is one of the most commonly performed children's surgeries and produces a
consistent pattern and intensity of pain in the recovery period. These qualities make this
surgery ideal for the investigation of pain relieving medications. Adequate analgesia for
tonsillectomy in the perioperative period presents a challenge to the anesthetist because
opiates, which provide the most effective analgesia, are associated with a high incidence of
nausea and vomiting, respiratory depression, and sedation. These effects make recovery from
tonsillectomy particularly hazardous in children with Obstructive Sleep Apnea Syndrome (OSAS)
(the primary indication for tonsillectomy or adenotonsillectomy) thus alternatives to
opiates have been sought. Gabapentin is a drug with an extensive safety record in the
treatment of children's seizures, and chronic pain syndromes. Recently studies have
demonstrated new modes of action for this medication, both directly on pain and in increasing
the efficacy of conventional opiate (morphine) pain relieving medications. As such it may
have role in the relief of acute pain. We hypothesize that given preoperatively as a single
dose; gabapentin will reduce postoperative pain and opiate requirement in children undergoing
tonsillectomy. Randomization will follow a computer generated random pattern with 14 patients
in each group (placebo or gabapentin). Pain and sedation will be recorded as will the
incidence of vomiting, dizziness and pruritis. Pain will be assessed using the Coloured
Analogue Scale and sedation with the University of Michigan Sedation Scale. The time to first
oral intake of fluids will also be recorded. All recordings will be made at 5-minute
intervals from time of extubation (time = 0) and will be made by an independent blinded
recovery nurse. Subjects will stay in the PACU for a minimum of one hour from time zero, and
will only be discharged to the Surgical Daycare Unit at a point after this when two
successive pain measurements demonstrate a score of 3 or less. In the Surgical Daycare Unit
pain assessment will continue at intervals of 30 minutes to a total time of 4 hours from time
zero and will be recorded by a member of the research team blinded to nature of
premedication. A telephone interview will be scheduled with the subject's parents at 24 hours
from time zero.
Eligibility
Minimum age: 5 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Tonsillectomy
- Adenotonsillectomy
- ASA status 1 to 3
- Weight < 60 kg
- BMI < 30
Locations and Contacts
Joanne Lim, Phone: 604-875-2000, Ext: 6669, Email: jlim2@cw.bc.ca
BC Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada; Recruiting
Joanne Lim, Phone: 604-875-2000, Ext: 6669, Email: jlim2@cw.bc.ca
Additional Information
Starting date: July 2007
Ending date: June 2009
Last updated: August 27, 2008
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