A randomised controlled trial on the efficacy of activated charcoal in lowering blood paracetamol concentrations in paracetamol overdose patients.

A randomised controlled trial of the efficacy of activated charcoal in paracetamol overdose

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2019/011

Enrollment

Unknown

Registered

2019-03-15

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paracetamol overdose

Interventions

1. Study Setting: Emergency Treatment Unit and the Medical Wards of Teaching Hospital, Anuradhapura. 2. Method of Randomisation: Simple randomization. 3. Activated Charcoal 50g dissolved in 100ml wate

Eligibility

Inclusion criteria

Inclusion criteria: All patients (>16y) with paracetamol overdoses (>5g) presenting within 8h of ingestion.

Exclusion criteria

Exclusion criteria: Staggered paracetamol overdoses and late presentations (>8h).

Design outcomes

Primary

Measure	Time frame
The primary outcome will be a clinically significant reduction in the Area Under Curve (AUC) of in patients receiving charcoal compared to those not receiving charcoal. Area Under the Curve (AUC) = [Dose] * [Fraction Absorbed (F)] / [Clearance (CL)]. The AUC will be estimated by first modelling the data using population analysis techniques to determine the best fit to all of the data for patients taking paracetamol in the trial. Once a final model is established this will be used to estimate the individual predicted AUC for each patient which will then be compared between those receiving and not receiving charcoal. A 20% reduction in the AUC/dose will be regarded as clinically significant based on previous pharmacokinetic-pharmacodynamic studies [The blood samples will be collected in all patients (both groups) on following time points after the ingestion of paracetamol. 1.Time of admission 2.4hours 3.8hours 4.12hours 5.24hours 6.48hours 7.72hours 8.96hours 9.120hours AUC will be calculated based on the paracetamol concentration data of all the blood samples, after the trial has finished. ]	—

Measure

Time frame

The primary outcome will be a clinically significant reduction in the Area Under Curve (AUC) of in patients receiving charcoal compared to those not receiving charcoal. Area Under the Curve (AUC) = [Dose] * [Fraction Absorbed (F)] / [Clearance (CL)]. The AUC will be estimated by first modelling the data using population analysis techniques to determine the best fit to all of the data for patients taking paracetamol in the trial. Once a final model is established this will be used to estimate the individual predicted AUC for each patient which will then be compared between those receiving and not receiving charcoal. A 20% reduction in the AUC/dose will be regarded as clinically significant based on previous pharmacokinetic-pharmacodynamic studies [The blood samples will be collected in all patients (both groups) on following time points after the ingestion of paracetamol. 1.Time of admission 2.4hours 3.8hours 4.12hours 5.24hours 6.48hours 7.72hours 8.96hours 9.120hours AUC will be calculated based on the paracetamol concentration data of all the blood samples, after the trial has finished. ]

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Secondary

Measure	Time frame
(1) Reduction of the apparent half-life of elimination (t1/2?) in patients receiving charcoal compared to those not receiving charcoal.The decline of the Paracetamol plasma concentration is not due to elimination alone. Other factors such as absorption rate or distribution rate influence the declining of plasma concentration. In such conditions, the observed half-life is not a true elimination half-life hence called apparent half-life of elimination (time taken for paracetamol concentration to become 50% of the initial concentration. (2) Proportion of patients with a ALT >150IU/L after 24 hours of ingestion. (3) Proportion of patients who have their on-admission ALT values doubled by 24 hours. (4) Proportion of patients with an ALT >1000IU/L (hepatotoxicity) (5) Proportion of patients with adverse effects of charcoal such as vomiting and aspiration pneumonitis. (6) Reduction in other biomarkers of hepatotoxicity at 24 hours (miRNA-122 and INR at 24h.) [(1) 4,8,12,24,48,72,96,120 hours post ingestion (2) 24 hours post ingestion (3) 24 hours post ingestion (4) 48 hours post ingestion (5) 24 hours post ingestion (6) 24 hours post ingestion]	—

Measure

Time frame

(1) Reduction of the apparent half-life of elimination (t1/2?) in patients receiving charcoal compared to those not receiving charcoal.The decline of the Paracetamol plasma concentration is not due to elimination alone. Other factors such as absorption rate or distribution rate influence the declining of plasma concentration. In such conditions, the observed half-life is not a true elimination half-life hence called apparent half-life of elimination (time taken for paracetamol concentration to become 50% of the initial concentration. (2) Proportion of patients with a ALT >150IU/L after 24 hours of ingestion. (3) Proportion of patients who have their on-admission ALT values doubled by 24 hours. (4) Proportion of patients with an ALT >1000IU/L (hepatotoxicity) (5) Proportion of patients with adverse effects of charcoal such as vomiting and aspiration pneumonitis. (6) Reduction in other biomarkers of hepatotoxicity at 24 hours (miRNA-122 and INR at 24h.) [(1) 4,8,12,24,48,72,96,120 hours post ingestion (2) 24 hours post ingestion (3) 24 hours post ingestion (4) 48 hours post ingestion (5) 24 hours post ingestion (6) 24 hours post ingestion]

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Countries

Sri Lanka

Contacts

Public ContactN. K. Anjana Silva

Senior Lecturer

nkanjanasilva@gmail.com0252226388

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026