Comparing Intravenous and Oral Paracetamol for Cholecystectomy

Melbourne Health30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Laparoscopic Cholecystectomy

Interventions

Paracetamol (acetaminophen)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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