A comparison of two different durations of the antidote acetylcysteine for paracetamol overdose.

Phase 4

Recruiting

• Conditions: Paracetamol toxicity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Mental Health - Suicide

• Registration Number: ACTRN12616001617459
• Lead Sponsor: Colin Page

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1.Single immediate release paracetamol overdoses of 30g or less with an initial paracetamol concentration above but less than twice the nomogram line (paracetamol ratio <2)
2.Acetylcysteine can be safely commenced within 8 hours of ingestion.
3.Informed consent can be obtained.

The paracetamol ratio is the first paracetamol concentration taken between four and 16 hours post ingestion divided by the paracetamol concentration on the 150mg/L at four-hour standard nomogram line at the same time point.

Exclusion Criteria

1. Staggered or repeated immediate release paracetamol overdoses.
2. Single, staggered or repeated overdoses of sustained release paracetamol.
3. Repeated supratherapeutic ingestion of paracetamol.
4. Late presentation i.e. >8 hours since ingestion timea.
5. >30g paracetamolb or paracetamol ratio >2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be a comparison between the standard and the experimental arm of the absolute difference between the alanine aminotransferase (ALT) on admission and 24 hours post ingestion. The ALT is measured by serum assay.[On admission to hospital and at 24 hours post ingestion of paracetamol.]