Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000600640
Ethics application status
Approved
Date submitted
4/10/2005
Date registered
5/10/2005
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of parecoxib on post craniotomy analgesia.
Scientific title
A prospective randomised controlled, double-blind study of Parecoxib versus placebo for postoperative analgesia following craniotomy surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia for craniotomy surgery. 729 0
Condition category
Condition code
Anaesthesiology 806 806 0 0
Pain management
Surgery 807 807 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective randomised controlled, double-blind study has been designed to examine if a single dose of Parecoxib 40mg decreases postoperative pain and morphine requirements for 24 hours following craniotomy surgery.
Intervention code [1] 696 0
Treatment: Drugs
Comparator / control treatment
Saline placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 1034 0
Postoperative pain assessment
Timepoint [1] 1034 0
At 24 hours postop
Primary outcome [2] 1035 0
Morphine requirements
Timepoint [2] 1035 0
At 24 hours postop
Secondary outcome [1] 1924 0
Postoperative measurement of patient sedation, nausea and vomiting and the use of antiemetics 24 hours postop.
Timepoint [1] 1924 0
At 24 hours post op

Eligibility
Key inclusion criteria
Alert and orientated, patients presenting for elective craniotomy.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy or contraindication to NSAID's, sulphonamides or morphine.Combination ACE inhibitors and diuretics OR either an ACE inhibitor or diuretic if over 70 years oldAsthma if aggrevated by NSAID's or never taken NSAID'sSignificamt peptic ulcer diseaseRenal impairmentChronic pain conditions or taking oral morphine or NSAID's taken on day of surgeryNon English speaking or unable to understand Visual Analogue ScoreIschaemic Heart Diseae or Cerebrovascular DiseaseAny preoperative confusion or sedation.

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 envelopes opened at the time of randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer softeware PC-Plan was used to generate random allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 893 0
Self funded/Unfunded
Name [1] 893 0
Country [1] 893 0
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital Melbourne
Address
Fitzroy
Country
Australia
Secondary sponsor category [1] 755 0
None
Name [1] 755 0
No secondary sponsor
Address [1] 755 0
Country [1] 755 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35991 0
Address 35991 0
Country 35991 0
Phone 35991 0
Fax 35991 0
Email 35991 0
Contact person for public queries
Name 9885 0
Ms Simone Said
Address 9885 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 9885 0
Australia
Phone 9885 0
+61 3 92884245
Fax 9885 0
Email 9885 0
[email protected]
Contact person for scientific queries
Name 813 0
Dr Simon Jones
Address 813 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 813 0
Australia
Phone 813 0
+61 3 92884245
Fax 813 0
Email 813 0
[email protected],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.