Comparing Intravenous and Oral Paracetamol for Cholecystectomy

This study has been completed.

First Received: February 13, 2006 Last Updated: March 8, 2007 History of Changes

Sponsored by:	Melbourne Health
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00292214

Purpose

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.

Condition	Intervention	Phase
Laparoscopic Cholecystectomy	Drug: Paracetamol (acetaminophen)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy

Resource links provided by NLM:

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations

Secondary Outcome Measures:

Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.

Estimated Enrollment:	30
Study Start Date:	October 2005
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292214

Locations

Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052

Sponsors and Collaborators

Melbourne Health

Investigators

Principal Investigator:

Malcolm Hogg, Anaesthetist

Melbourne Health

More Information

No publications provided

Study ID Numbers:	2005.138
Study First Received:	February 13, 2006
Last Updated:	March 8, 2007
ClinicalTrials.gov Identifier:	NCT00292214 History of Changes
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Melbourne Health:

paracetamol
acetaminophen
pharmacokinetic
intravenous

oral
analgesia
pain
opioid

Study placed in the following topic categories:

Analgesics, Non-Narcotic
Pain
Peripheral Nervous System Agents
Analgesics
Acetaminophen

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on July 02, 2009