Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000908235
Ethics application status
Approved
Date submitted
19/10/2009
Date registered
20/10/2009
Date last updated
20/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative oral paracetamol versus intraoperative intravenous paracetamol: plasma levels in the recovery room
Scientific title
Does giving paracetamol intravenously during an operation result in significantly higher plasma paracetamol levels in the early postoperative period than giving the same dose orally as a premedicant?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative plasma paracetamol levels 252026 0
Postoperative pain scores 252031 0
Postoperative analgesia requirements 252032 0
Length of stay in recovery 252033 0
Condition category
Condition code
Anaesthesiology 252219 252219 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 g intravenous (IV) paracetamol given intraoperatively
Intervention code [1] 241426 0
Treatment: Drugs
Comparator / control treatment
1g oral paracetamol given 30-60 minutes preoperatively
Control group
Active

Outcomes
Primary outcome [1] 253089 0
Plasma paracetamol levels from venous blood sample taken from contralateral arm to the drip.
Assay performed by Canterbury Health Laboratories using a colourimetric assay on the c8000 analysers. Units in mcmol/l.
Timepoint [1] 253089 0
30 minutes after arrival in the recovery room
Secondary outcome [1] 257949 0
Postoperative pain scores at 10 minute intervals using a 100mm visual analogue scale (VAS)
Timepoint [1] 257949 0
10 minute intervals until discharge from recovery
Secondary outcome [2] 257950 0
Postoperative rescue analgesia requirements (fentanyl mcg)
Timepoint [2] 257950 0
Total amount required during the patient's stay in recovery
Secondary outcome [3] 257951 0
Duration of stay in recovery ie how long it took for patient to reach standard discharge criteria from recovery
Timepoint [3] 257951 0
Duration of stay in reocvery

Eligibility
Key inclusion criteria
Day case arthroscopies
Suitable for laryngeal mask anaesthesia
American Society of Anaesthesiologists (ASA) 1 & 2
Body mass index (BMI) less than 35
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to paracetamol
BMI over 35
Requiring intubation rather than laryngeal mask airway (LMA) use
Requiring any other intraoperative analgesics other than IV fentanyl

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)
Subjects enrolled by study investigator on the day of admission. Letter explaining trial also sent to patients prior to their surgery.
Oral tablets (either active paracetamol or placebo) administered from sealed numbered envelopes. Placebo identical to active tablets.
Tablets administered by blinded nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised using a computer generated vector (prepared by our statistician).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2270 0
New Zealand
State/province [1] 2270 0
Canterbury

Funding & Sponsors
Funding source category [1] 243897 0
Hospital
Name [1] 243897 0
Christchurch Public Hospital
Country [1] 243897 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Public Hospital
Address
2 Riccarton Avenue
Addington
8011
Christchurch
Country
New Zealand
Secondary sponsor category [1] 251240 0
Hospital
Name [1] 251240 0
Burwood Hospital
Address [1] 251240 0
225 Mairehau Rd
Burwood 8083
Christchurch
Country [1] 251240 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244013 0
Upper South A Ethics Committee
Ethics committee address [1] 244013 0
C/O Ministry of Health
4th floor
250 Oxford Tce
Central Christchurch
8011
PO Box 3877
Ethics committee country [1] 244013 0
New Zealand
Date submitted for ethics approval [1] 244013 0
Approval date [1] 244013 0
12/11/2008
Ethics approval number [1] 244013 0
URA/08/09/060

Summary
Brief summary
Paracetamol is traditionally given by anaesthetists in tablet form around one hour before an operation with the intention of providing good pain relief in the period following the operation. Recently, an IV formulation has become available and can be given during the operation. We compared which of these techniques gave higher levels of paracetamol in the bloodstream after the operation. We also looked at how much extra pain relief was needed in the recovery room, how long patients stayed in the recovery room and how sore they were.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30398 0
Address 30398 0
Country 30398 0
Phone 30398 0
Fax 30398 0
Email 30398 0
Contact person for public queries
Name 13645 0
Dr Christian Brett
Address 13645 0
C/o Department of Anaesthesia
Christchurch Public Hospital
2 Riccarton Ave
Private Bag 4710
8011
Christchurch
Country 13645 0
New Zealand
Phone 13645 0
+64 3 3640288
Fax 13645 0
+64 3 3490420
Email 13645 0
[email protected]
Contact person for scientific queries
Name 4573 0
Dr Christian Brett
Address 4573 0
C/o Department of Anaesthesia
Christchurch Public Hospital
2 Riccarton Ave
8011
Private Bag 4710
Country 4573 0
New Zealand
Phone 4573 0
+64 3 3640288
Fax 4573 0
+64 3 3490420
Email 4573 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.