Comparing Intravenous and Oral Paracetamol for Cholecystectomy
Information source: Melbourne Health
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laparoscopic Cholecystectomy
Intervention: Paracetamol (acetaminophen) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Melbourne Health Official(s) and/or principal investigator(s):
Malcolm Hogg, Anaesthetist, Principal Investigator, Affiliation: Melbourne Health
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.
Clinical Details
Official title: Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Secondary outcome: Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Royal Melbourne Hospital, Melbourne, Victoria 3052, Australia
Additional Information
Starting date: October 2005
Ending date: October 2006
Last updated: March 8, 2007
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