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Paracetamol pilot study - Oral Vs Intravenous antidotes

Phase 1
Recruiting
Conditions
iver cell injury in paracetamol overdose
Registration Number
SLCTR/2017/036
Lead Sponsor
South Asian Clinical Toxicology Research Collaboration (SACTRC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Patients >16 years of age with acute paracetamol poisoning. i.e who present within 10 hours of ingestion and whose plasma paracetamol levels falls above Prescott normogram line.

Exclusion Criteria

1. Patients presenting more than 10 hours after poisoning.
2. Patients who have already received an antidote (possible in other hospitals prior to transfer).
3. Patients who have received charcoal (which would interfere with oral antidotes).
4. Patients under the age of 16.
5. Patients who are unable to give the amount of paracetamol ingested and the time of ingestion
6. Patients who are institutionalized for any mental health condition.
7. Patients with known cognitive impairment (e.g. dementia).
8. Patients with an unrelated life threatening illness (e.g. terminal cancer).
9. Patients who are known to be pregnant or breast feeding.
(This is simply a practical decision. There are no known risks these patients will be subjected to by being treated with these antidotes)
10. Patients who have had a paracetamol overdose in the previous 4 weeks or have taken a significant dose of any other toxic substance in addition to paracetamol.
11. Patients who are on warfarin.
12. Patients who have taken a staggered dose of paracetamol (over more than a 2-hour period).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rise of ALT to more than 50% of the baseline value within 24 hours. [On admission and at 8, 16, 24, and 36 hours post ingestion, and thereafter daily until discharge.]<br>
Secondary Outcome Measures
NameTimeMethod
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