Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000345987
Ethics application status
Approved
Date submitted
28/03/2011
Date registered
1/04/2011
Date last updated
16/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Parecoxib and paracetamol for pain relief following minor day stay gynaecological surgery (The PAINFREE Trial)
Scientific title
Early postoperative analgesia from parecoxib, paracetamol or both among patients having minor gynaecological sugery
Secondary ID [1] 259873 0
Nil
Universal Trial Number (UTN)
U1111-1120-3127
Trial acronym
The PAINFREE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia after minor gynaecological surgery 265462 0
Condition category
Condition code
Anaesthesiology 265618 265618 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: single dose intraoperative intravenous parecoxib 40 mg
Arm 2: single dose intraoperative intravenous paracetamol 2 g
Arm 3: single dose intraoperative intravenous parecoxib 40 mg and intravenous paracetamol 2 g
Arm 4: single dose intraoperative intravenous placebos

This 2 x2 factorial design allows efficient evaluation of two treatments and in this case comparison not only of parecoxib versus placebo and paracetomol versus placebo but also the interaction of these two drugs (both versus placebo) and evaluation of all patients receiving each drug eg. Arms 1 & 2 vs Arm 4 and Arms 2 & 3 vs Arm 4.
Intervention code [1] 264294 0
Treatment: Drugs
Comparator / control treatment
Arm 4: Single dose itraoperative intravenous normal saline 200 ml and single dose intraoperative intravenous normal saline 2 ml
Control group
Placebo

Outcomes
Primary outcome [1] 262401 0
0-28 'overall benefit of analgesia score'. This is a validated, scored patient questionnaire consisting of 7 questions each with four response options. The maximum score is 28 and a low score represents high benefit.
Timepoint [1] 262401 0
24 hours postoperatively
Primary outcome [2] 262402 0
0-10 verbal numerical rating pain with movement score. with a minimum value of zero and a maximum value of ten
Timepoint [2] 262402 0
1 hour postoperatively
Secondary outcome [1] 273712 0
Area under the curve pain score with movement
Timepoint [1] 273712 0
24 hours postoperatively
Secondary outcome [2] 273713 0
Area under the curve pain score at rest
Timepoint [2] 273713 0
24 hours postoperatively

Eligibility
Key inclusion criteria
Dilatation and curettage
American Society of Anesthesiologists physical status 1 or 2
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal dysfunction
Hypertension
Ischaemic heart disease
Cerebrovascular disease
Peptic ulcer or gastro-intestinal reflux disease
Aspirin or nonsteroidal anti-inflammatory drug induced asthma
Allergy to paracetamol, parecoxib or sulphonamides
Hepatic dysfunction
Taking analgesic drugs within 24 hours of surgery
Unsuitable for anaesthesia with volatile anaesthetics or requiring intubation
Prophylactic antiemetic therapy indicated

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)
Enrolment in preoperative clinic or ward after written informed consent
Allocation by sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
This study has a 2 x2 factorial design. This 2 x2 factorial design allows efficient evaluation of two treatments and in this case comparison not only of parecoxib versus placebo and paracetomol versus placebo but also the interaction of these two drugs (both versus placebo) and evaluation of all patients receiving each drug eg. Arms 1 & 2 vs Arm 4 and Arms 2 & 3 vs Arm 4
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2011
Actual
19/04/2011
Date of last participant enrolment
Anticipated
Actual
14/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264755 0
Self funded/Unfunded
Name [1] 264755 0
Country [1] 264755 0
Australia
Primary sponsor type
Government body
Name
Women's and Newborn Health Service
Address
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 263876 0
None
Name [1] 263876 0
Address [1] 263876 0
Country [1] 263876 0
Other collaborator category [1] 251903 0
University
Name [1] 251903 0
The University of Western Australia
Address [1] 251903 0
35 Stirling Highway, Crawley WA 6009
Country [1] 251903 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266735 0
Women's and Newborn Health Service Ethics Committee
Ethics committee address [1] 266735 0
Administration
Princess Margaret Hospital
Roberts Rd
Subiaco WA 6008
Ethics committee country [1] 266735 0
Australia
Date submitted for ethics approval [1] 266735 0
Approval date [1] 266735 0
18/03/2011
Ethics approval number [1] 266735 0
1882/EW

Summary
Brief summary
The study objective is to compare the analgesic efficacy and quality of postoperative pain relief following minor gynaecological surgery between four different intra-operative analgesic regimens based on opioid plus either paracetamol, parecoxib, paracetamol and parecoxib in combination or placebo.
The null hypothesis is that there is no difference in the analgesic efficacy and quality of pain relief provided by either paracetamol, parecoxib, paracetamol and parecoxib in combination or placebo in patients undergoing minor gynaecological surgery.
Trial website
Nil
Trial related presentations / publications
Mohamad AH, McDonnell NJ, Bloor M, Nathan EA, Paech MJ. Parecoxib and paracetamol for pain relief following minor day-stay gynaecological surgery. Anaesth Intensive Care 2014;42(1):43-50
Public notes

Contacts
Principal investigator
Name 32400 0
A/Prof Nolan McDonnell
Address 32400 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco
WA 6008
Country 32400 0
Australia
Phone 32400 0
61 8 93402250
Fax 32400 0
Email 32400 0
[email protected]
Contact person for public queries
Name 15647 0
Prof Michael Paech
Address 15647 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd, Subiaco WA 6008
Country 15647 0
Australia
Phone 15647 0
61 8 93402250/00
Fax 15647 0
61 8 9340 2227
Email 15647 0
[email protected]
Contact person for scientific queries
Name 6575 0
Prof Michael Paech
Address 6575 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd, Subiaco WA 6008
Country 6575 0
Australia
Phone 6575 0
61 8 9340 2250/00
Fax 6575 0
61 8 9340 2227
Email 6575 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseMethylnaltrexone to prevent intrathecal morphine-induced pruritus after Caesarean delivery: A multicentre, randomized clinical trial.2015https://dx.doi.org/10.1093/bja/aeu410
N.B. These documents automatically identified may not have been verified by the study sponsor.