Comparing Intravenous and Oral Paracetamol for Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292214
• Other study ID #: 2005.138
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2006
• Last updated: March 8, 2007
• Start date: October 2005
• Est. completion date: October 2006

Study information

• Verified date: February 2006
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• Paracetamol (acetaminophen)

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Secondary	Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.