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Comparing Intravenous and Oral Paracetamol for Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292214
First Posted: February 15, 2006
Last Update Posted: March 9, 2007
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.
Information provided by:
Melbourne Health
  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 4

Study Type: Interventional
Study Design: 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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00292214     History of Changes
Other Study ID Numbers: 2005.138
First Submitted: February 13, 2006
First Posted: February 15, 2006
Last Update Posted: March 9, 2007
Last Verified: February 2006

Keywords provided by Melbourne Health:
paracetamol
acetaminophen
pharmacokinetic
intravenous
oral
analgesia
pain
opioid

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