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Trial registered on ANZCTR


Registration number
ACTRN12615000322538
Ethics application status
Approved
Date submitted
26/03/2015
Date registered
9/04/2015
Date last updated
13/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative plasma and cerebrospinal fluid pharmacokinetics of paracetamol following intravenous and oral administration
Scientific title
Plasma and cerebrospinal fluid concentrations of 1 g intravenous paracetamol compared with 1 g and 1.5 g oral paracetamol in adult surgical patients
Secondary ID [1] 286415 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesic concentrations of paracetamol 294582 0
Condition category
Condition code
Anaesthesiology 294883 294883 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single bolus dose of 1 g intravenous paracetamol given immediately before induction of spinal anaesthesia
Intervention code [1] 291488 0
Treatment: Drugs
Comparator / control treatment
Single bolus dose of 1 g oral paracetamol given immediately before induction of spinal anaesthesia (Arm 1)

Single bolus dose of 1.5 g oral paracetamol given immediately before induction of spinal anaesthesia (Arm 2)
Control group
Dose comparison

Outcomes
Primary outcome [1] 294635 0
Cerebrospinal fluid concentration of paracetamol
Timepoint [1] 294635 0
0, 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes following paracetamol administration
Secondary outcome [1] 313777 0
Plasma concentration of paracetamol
Timepoint [1] 313777 0
0, 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes following paracetamol administration

Eligibility
Key inclusion criteria
1. aged 18 years and over
2. presenting for elective surgery under spinal anaesthesia
3. able to communicate in English
4. no contraindication to paracetamol
5. no paracetamol within previous 12 hours
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. aged <18 years
2. not planned for spinal anaesthesia
3. unable to communicate in English
4. contraindication to paracetamol
5. paracetamol within previous 12 hours

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)
Patients were approached by study staff before surgery and written informed consent was obtained. Randomisation occurred after consent was obtained. Randomisation results were concealed in sequentially numbered opaque envelopes. The appropriate envelope was opened just before paracetamol administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was computer-generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The scientist analysing the plasma and CSF samples was blind to group allocation.
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
The original intention was to use non-compartmental pharmacokinetic analysis techniques to address the study objectives, however, on completion of data collection and visualisation of the data, it was decided to employ population pharmacokinetic analysis techniques (i.e. nonlinear mixed-effects modelling).

The sample size for this trial was based upon the original primary endpoint of the maximum paracetamol concentration (Cmax) in CSF after IV or oral administration. Using information published previously, it was determined that a sample size of 7 patients per group would be sufficient to detect a 2.8 fold difference in CSF Cmax between the IV and oral treatment groups with 80% power and a type I error rate of 5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3608 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 9397 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 290987 0
Hospital
Name [1] 290987 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Address [1] 290987 0
Grattan St, Parkville, VIC, 3050.
Country [1] 290987 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan St, Parkville, VIC, 3050.
Country
Australia
Secondary sponsor category [1] 289667 0
None
Name [1] 289667 0
Address [1] 289667 0
Country [1] 289667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292576 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 292576 0
Grattan St, Parkville, VIC, 3050.
Ethics committee country [1] 292576 0
Australia
Date submitted for ethics approval [1] 292576 0
Approval date [1] 292576 0
05/12/2007
Ethics approval number [1] 292576 0
2007.233

Summary
Brief summary
The primary purpose of this study was to determine the concentrations of the drug paracetamol in the plasma and cerebrospinal fluid after intravenous and oral administration to adult patients having surgery under spinal anaesthesia.
Trial website
Trial related presentations / publications
None yet
Public notes

Contacts
Principal investigator
Name 56050 0
Dr Malcolm Hogg
Address 56050 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Grattan St, Parkville, VIC, 3050
Country 56050 0
Australia
Phone 56050 0
+61-3-93427540
Fax 56050 0
Email 56050 0
malcolm.hogg@mh.org.au
Contact person for public queries
Name 56051 0
Dr Malcolm Hogg
Address 56051 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Grattan St, Parkville, VIC, 3050
Country 56051 0
Australia
Phone 56051 0
+61-3-93427540
Fax 56051 0
Email 56051 0
malcolm.hogg@mh.org.au
Contact person for scientific queries
Name 56052 0
Dr Malcolm Hogg
Address 56052 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Grattan St, Parkville, VIC, 3050
Country 56052 0
Australia
Phone 56052 0
+61-3-93427540
Fax 56052 0
Email 56052 0
malcolm.hogg@mh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary