Comparing Intravenous and Oral Paracetamol for Cholecystectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

February 13, 2006

Last Updated Date

March 8, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00292214 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparing Intravenous and Oral Paracetamol for Cholecystectomy

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Laparoscopic Cholecystectomy

Intervention ^ICMJE

Drug: Paracetamol (acetaminophen)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00292214

Responsible Party

Study ID Numbers ^ICMJE

2005.138

Study Sponsor ^ICMJE

Melbourne Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Malcolm Hogg, Anaesthetist

Melbourne Health

Information Provided By

Melbourne Health

Verification Date

February 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP