Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000480583
Ethics application status
Approved
Date submitted
4/10/2006
Date registered
23/11/2006
Date last updated
19/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parecoxib for postoperative pain after minor gynaecological surgery
Scientific title
Single dose parecoxib for pain relief following dilatation and curettage and/or hysteroscopy
Secondary ID [1] 281267 0
1282/EP
Universal Trial Number (UTN)
Trial acronym
The COMFIT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain following dilatation and currettage and/or hystersocopy 1457 0
Condition category
Condition code
Reproductive Health and Childbirth 1553 1553 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised double blind placebo-controlled parallel group study of a single intraoperative dose of intravenous parecoxib 40 mg versus saline placebo
Intervention code [1] 1389 0
Treatment: Drugs
Comparator / control treatment
Single intraoperative dose of intravenous saline placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2145 0
0 - 10 cm numerical rating scale pain score with movement
Timepoint [1] 2145 0
At one hour postoperatively
Secondary outcome [1] 3717 0
Pain score
Timepoint [1] 3717 0
at rest 1 hour postop
Secondary outcome [2] 3718 0
Pain score
Timepoint [2] 3718 0
at 2 and 24 hours postop
Secondary outcome [3] 3719 0
Time to first use of postoperative intravenous fentanyl analgesia
Timepoint [3] 3719 0
as occurs up until discharge from hospital
Secondary outcome [4] 3720 0
Time to first use of postoperative oral tramadol analgesia
Timepoint [4] 3720 0
as occurs until discharge from hospital
Secondary outcome [5] 3721 0
Total dose of intravenous fentanyl
Timepoint [5] 3721 0
at discharge from recovery room
Secondary outcome [6] 3722 0
Total dose of oral tramadol
Timepoint [6] 3722 0
at 24 h postop
Secondary outcome [7] 3723 0
Nausea/vomiting incidence
Timepoint [7] 3723 0
at 24 h postop
Secondary outcome [8] 3724 0
Headache incidence
Timepoint [8] 3724 0
at 24 h postop
Secondary outcome [9] 3725 0
Quality of recovery (QoR)score
Timepoint [9] 3725 0
at 24 hour postop
Secondary outcome [10] 3726 0
Health outcomes recovery (H.O.R) questionnaire score
Timepoint [10] 3726 0
at 24 hour postop
Secondary outcome [11] 3727 0
Satisfaction score
Timepoint [11] 3727 0
at 24 h postop

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status classifiaction I or II Undergoing dilatation and curettage +/- hysteroscopy
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal dysfunction Hypertension History of sulphonamide allergy Unsuitable for general anaesthesia with maintenance by inhalational agent Use of suxamethonium Preoperative use of NSAID or opiate analgesics

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple computer derived randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects,assessors and data analysts are blinded
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1693 0
Hospital
Name [1] 1693 0
King Edward Memorial Hospital for Women Department of Anaesthesia and Pain Medicine
Country [1] 1693 0
Australia
Primary sponsor type
Individual
Name
individual (Kate Luscombe)
Address
Department of Anaesthesia and Pain Medicine, king Edward Memorial Hospital for Women, 374 bagot rd Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 1494 0
None
Name [1] 1494 0
nil
Address [1] 1494 0
Country [1] 1494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3144 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 3144 0
Ethics committee country [1] 3144 0
Australia
Date submitted for ethics approval [1] 3144 0
Approval date [1] 3144 0
04/07/2006
Ethics approval number [1] 3144 0
EC06-41

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27616 0
Address 27616 0
Country 27616 0
Phone 27616 0
Fax 27616 0
Email 27616 0
Contact person for public queries
Name 10578 0
Michael Paech
Address 10578 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Country 10578 0
Australia
Phone 10578 0
+61 8 93402222
Fax 10578 0
+61 8 93402260
Email 10578 0
michael.paech@health.wa.gov.au
Contact person for scientific queries
Name 1506 0
Nolan McDonnell
Address 1506 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Country 1506 0
Australia
Phone 1506 0
+61 8 93402222
Fax 1506 0
+61 8 93402260
Email 1506 0
nolan.mcdonnell@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.