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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00292214




Registration number
NCT00292214
Ethics application status
Date submitted
13/02/2006
Date registered
15/02/2006
Date last updated
9/03/2007

Titles & IDs
Public title
Comparing Intravenous and Oral Paracetamol for Cholecystectomy
Scientific title
Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
Secondary ID [1] 0 0
2005.138
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Cholecystectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Males and females aged 18-75
* Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
* History of allergy or sensitivity to paracetamol
* Administration of oral paracetamol within previous 8 hours
* American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
* Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
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] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Malcolm Hogg, Anaesthetist
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00292214