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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Paracetamol (acetaminophen)

Treatment: Drugs: Paracetamol (acetaminophen)
Intervention code [1] 0 0
Treatment: Drugs
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
To determine the amount of paracetamol in the blood when given in either intravenous or oral
forms prior to cholecystectomy. The clinical effectiveness of each form will also be
evaluated with pain scores and the use of other pain relief drugs.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00292214
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00292214