Comparing Intravenous and Oral Paracetamol for Cholecystectomy

NCT ID: NCT00292214

Last Updated: 2007-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Paracetamol (acetaminophen)

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melbourne Health

OTHER

Sponsor Role lead

Principal Investigators

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Malcolm Hogg, Anaesthetist

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

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Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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2005.138

Identifier Type: -

Identifier Source: org_study_id

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