Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000786695
Ethics application status
Approved
Date submitted
9/12/2005
Date registered
12/12/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of a single dose of intravenous paracetamol with rectal paracetamol and placebo in the treatment of mild to moderate postoperative pain
Scientific title
Comparison of a single dose of intravenous paracetamol with rectal paracetamol and placebo in the treatment of mild to moderate postoperative pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 945 0
Condition category
Condition code
Other 1014 1014 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of either intravenous or rectal paracetamol prior to induction of anaesthesia
Intervention code [1] 795 0
Treatment: Drugs
Comparator / control treatment
Placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 1352 0
Pain relief by VAS (Visual Analogue Score) in the postoperative period
Timepoint [1] 1352 0
At awakening and at discharge from recovery area
Secondary outcome [1] 2413 0
1. Total dose of rescue analgesia (morphine) required in recovery period.
Timepoint [1] 2413 0
Secondary outcome [2] 2414 0
2. Side effects of iv paracetamol measured by SAQ (Symptom Assessment Questionnaire).
Timepoint [2] 2414 0
Pre and postoperatively.
Secondary outcome [3] 2415 0
3. Paracetamol plasma levels
Timepoint [3] 2415 0
Measured at 30, 60 and 120 min after administration.

Eligibility
Key inclusion criteria
Female patients undergoing minor laparoscopic gynaecological surgeryASA I and II.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to paracetamol and/or morphineHepatic or renal dysfunction.

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)
Numbered containers for iv paracetamol/saline and paracetamol/glycerine suppositories
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
When patients fulfill inclusion criteria they will be randomised to one of 3 groups according to a computer generated randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1118 0
Commercial sector/Industry
Name [1] 1118 0
Bristol-Myers Squibb
Country [1] 1118 0
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Australia
Secondary sponsor category [1] 976 0
None
Name [1] 976 0
Nil
Address [1] 976 0
Country [1] 976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2433 0
Royal Brisbane & women Hospital Human Research Ethics Committee
Ethics committee address [1] 2433 0
Ethics committee country [1] 2433 0
Australia
Date submitted for ethics approval [1] 2433 0
Approval date [1] 2433 0
Ethics approval number [1] 2433 0

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

Contacts
Principal investigator
Name 35298 0
Address 35298 0
Country 35298 0
Phone 35298 0
Fax 35298 0
Email 35298 0
Contact person for public queries
Name 9984 0
Dominique Hopkins
Address 9984 0
Department of Anaesthesia
Royal Brisbane and Women Hospital
Level 4
Ned Hanlon Building
Herston QLD 4026
Country 9984 0
Australia
Phone 9984 0
+61 7 36367135
Fax 9984 0
Email 9984 0
[email protected]
Contact person for scientific queries
Name 912 0
Dominique Hopkins
Address 912 0
Department of Anaesthesia
Royal Brisbane and Women Hospital
Level 4
Ned Hanlon Building
Herston QLD 4026
Country 912 0
Australia
Phone 912 0
+61 7 36367135
Fax 912 0
Email 912 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
No additional documents have been identified.