Comparing Intravenous and Oral Paracetamol for Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292214
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : March 9, 2007
Information provided by:
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Drug: Paracetamol (acetaminophen) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
Study Start Date : October 2005
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292214

Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Melbourne Health
Principal Investigator: Malcolm Hogg, Anaesthetist Melbourne Health Identifier: NCT00292214     History of Changes
Other Study ID Numbers: 2005.138
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: March 9, 2007
Last Verified: February 2006

Keywords provided by Melbourne Health:

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs