Comparing Intravenous and Oral Paracetamol for Cholecystectomy

This study has been completed.
Information provided by:
Melbourne Health Identifier:
First received: February 13, 2006
Last updated: March 8, 2007
Last verified: February 2006
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy

Resource links provided by NLM:

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

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

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
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Please refer to this study by its identifier: NCT00292214

Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Melbourne Health
Principal Investigator: Malcolm Hogg, Anaesthetist Melbourne Health
  More Information

No publications provided Identifier: NCT00292214     History of Changes
Other Study ID Numbers: 2005.138
Study First Received: February 13, 2006
Last Updated: March 8, 2007
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Melbourne Health:

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015