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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00292214
Other study ID # 2005.138
Secondary ID
Status Completed
Phase Phase 4
First received February 13, 2006
Last updated March 8, 2007
Start date October 2005
Est. completion date October 2006

Study information

Verified date February 2006
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Males and females aged 18-75

- Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Paracetamol (acetaminophen)


Locations

Country Name City State
Australia Royal Melbourne Hospital Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Secondary Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
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