Comparing Intravenous and Oral Paracetamol for Cholecystectomy

Phase 4

Completed

• Conditions: Laparoscopic Cholecystectomy

• Registration Number: NCT00292214
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Status Verified: 2006-02
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-15
• Study Completion: 2006-10
• Last Update Submitted: 2007-03-08
• Last Update Posted: 2007-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia