Comparing Intravenous and Oral Paracetamol for Cholecystectomy

March 8, 2007 updated by: Melbourne Health

Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melbourne Health

Investigators

  • Principal Investigator: Malcolm Hogg, Anaesthetist, Melbourne Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

March 9, 2007

Last Update Submitted That Met QC Criteria

March 8, 2007

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005.138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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