Comparing Intravenous and Oral Paracetamol for Cholecystectomy
This study has been completed.
Information provided by:
First received: February 13, 2006
Last updated: March 8, 2007
Last verified: February 2006
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.
Drug: Paracetamol (acetaminophen)
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
||Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
Primary Outcome Measures:
- Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Secondary Outcome Measures:
- Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males and females aged 18-75
- Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia
- 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00292214
|Royal Melbourne Hospital
|Melbourne, Victoria, Australia, 3052 |
||Malcolm Hogg, Anaesthetist
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 13, 2006
||March 8, 2007
||Australia: National Health and Medical Research Council
Keywords provided by Melbourne Health:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents