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Trial registered on ANZCTR


Registration number
ACTRN12613000663752
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
19/06/2013
Date last updated
19/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of peri-operative gabapentin in the management of pain following tonsillectomy
Scientific title
The role of gabapentin in the management of pain following tonsillectomy in all patients over 16 years old, compared with placebo, with pain being the primary outcome assessed.
Secondary ID [1] 282418 0
Nil
Universal Trial Number (UTN)
U1111-1142-4754
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain following tonsillectomy 289005 0
Post-tonsillectomy analgesic consumption 289006 0
Post-tonsillectomy nausea 289267 0
Post-tonsillectomy vomiting 289268 0
Post-tonsillectomy return to normal activity 289269 0
Post-tonsillectomy return to normal diet 289270 0
Condition category
Condition code
Surgery 289350 289350 0 0
Other surgery
Anaesthesiology 289595 289595 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single pre-operative dose of oral gabapentin 600mg (capsule) given 30 minutes prior to induction with oral paracetamol 1g (tablet).
Intervention code [1] 287053 0
Treatment: Drugs
Comparator / control treatment
A single pre-operative dose of placebo given with paracetamol 1g.
Control group
Placebo

Outcomes
Primary outcome [1] 289459 0
The primary outcome measure is post-operative pain.
Timepoint [1] 289459 0
This will be assessed using a VAS, scoring at 2, 4, and 6 hours following surgery and on post-operative days 1 to 14.
Secondary outcome [1] 302537 0
Secondary outcomes will be post-operative analgesic consumption.
Timepoint [1] 302537 0
This will be assessed on post-operative days 1 to 14 by way of a questionnaire and recovery of un-used analgesia at the end of the 2 week period.
Secondary outcome [2] 303007 0
Post-operative nausea
Timepoint [2] 303007 0
Days 1-14 assessed by validated Postoperative Nausea and Vomiting (PONV) Intensity Scale.
Secondary outcome [3] 303008 0
Post-operative vomiting
Timepoint [3] 303008 0
Days 1-14 assessed by validated Postoperative Nausea and Vomiting (PONV) Intensity Scale.
Secondary outcome [4] 303009 0
Post-operative return to normal activity.
Timepoint [4] 303009 0
Indication by non-validated questionnaire developed specifically for this study of day return to normal activity (From days 1-14).
Secondary outcome [5] 303010 0
Post-operative return to normal diet.
Timepoint [5] 303010 0
Indication by non-validated questionnaire developed specifically for this study of day return to normal diet (From days 1-14).

Eligibility
Key inclusion criteria
Participants will be aged 16 years and over, scheduled for elective tonsillectomy between January 2014 and December 2014
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include contraindications to gabapentin, other concurrent procedures, revision or unilateral tonsillectomy, inability to complete the scoring charts, and those with suspected malignancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who fit the inclusion criteria will approached and given information regarding the trial, if they wish to participate then fully informed consent will be obtained. Computer-allocated randomization will allocate participants to groups A or B, the coding for active and placebo will be kept at Dunedin Hospital Pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis
Local data regarding recovery following tonsillectomy, acquired at four different time periods, was used as the basis for a power analysis. Assuming (from that study) the estimated the standard deviation for pain scores will be about 2.4 and the correlation between the follow-up measures will be about 0.8, 40 participants (20 in each arm) will be sufficient to demonstrate a 25% difference in post-operative pain scores between the two groups. For this trial statistical tests will be performed at the two-sided 0.05 level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5067 0
New Zealand
State/province [1] 5067 0
Otago

Funding & Sponsors
Funding source category [1] 287226 0
Charities/Societies/Foundations
Name [1] 287226 0
Royal Australasian College of Surgeons Scholarship Program
Country [1] 287226 0
Australia
Primary sponsor type
University
Name
Department of Surgical Sciences, University of Otago
Address
364 Leith Walk,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 285980 0
Charities/Societies/Foundations
Name [1] 285980 0
Royal Australasian College Surgeons
Address [1] 285980 0
Royal Australasian College of Surgeons
199 Ward Street
NORTH ADELAIDE SA 5006
AUSTRALIA
Country [1] 285980 0
Australia
Other collaborator category [1] 277374 0
Individual
Name [1] 277374 0
Associate Professor Patrick Dawes
Address [1] 277374 0
Department of Otolaryngology- Head and Neck Surgery
Dunedin Hospital,
Great King St,
Dunedin,
9016
Country [1] 277374 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289213 0
Scientific Peer Review Committee
Ethics committee address [1] 289213 0
Department of Surgical Sciences,
University of Otago,
Dunedin School of Medicine
First Floor, Dunedin Hospital
Great King Street
Dunedin 9016
New Zealand
Ethics committee country [1] 289213 0
New Zealand
Date submitted for ethics approval [1] 289213 0
19/03/2013
Approval date [1] 289213 0
08/04/2013
Ethics approval number [1] 289213 0

Summary
Brief summary
The primary purpose of the study is to assess whether gabapentin reduces post-operative pain after tonsillectomy compared to placebo.
The study's hypothesis is that gabapentin reduces post-operative pain after tonsillectomy compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39662 0
A/Prof Patrick Dawes
Address 39662 0
Department of Otolaryngology- Head and Neck Surgery
Dunedin Hospital
Great King St,
Dunedin,
9016
Country 39662 0
New Zealand
Phone 39662 0
+64 3 474 0999
Fax 39662 0
Email 39662 0
[email protected]
Contact person for public queries
Name 39663 0
James Sanders
Address 39663 0
Department of Otolaryngology- Head and Neck Surgery
Dunedin Hospital
Great King St,
Dunedin,
9016
Country 39663 0
New Zealand
Phone 39663 0
+64 3 474 0999
Fax 39663 0
Email 39663 0
[email protected]
Contact person for scientific queries
Name 39664 0
James Sanders
Address 39664 0
Department of Otolaryngology- Head and Neck Surgery
Dunedin Hospital
Great King St,
Dunedin,
9016
Country 39664 0
New Zealand
Phone 39664 0
+64 3 474 0999
Fax 39664 0
Email 39664 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23267Study protocol   
23268Statistical analysis plan   

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Sanders JG, Cameron C, Dawes PJD. Gabapentin in th... [More Details]

Documents added automatically
No additional documents have been identified.