What is the safe dose of diazepam that can be used as an effective adjunct treatment in organophosphate poisoning?

A dose-finding phase II study of diazepam in adult patients presenting with signs or symptoms of acute organophosphate poisoning

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64727867

Enrollment

Registered

2009-01-28

Start date

2008-11-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Organophosphate poisoning Injury, Occupational Diseases, Poisoning Toxic effect of pesticides

Interventions

The dose escalation relates to a course of diazepam. The first three doses are single doses of 2.5 mg, 5 mg, and 10 mg. The fourth group will receive a dose of 10 mg - and then two subsequent doses of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients (aged 16 to 60 years, either sex) with symptomatic acute OP poisoning

Exclusion criteria

Exclusion criteria: 1. Patients who do not consent 2. Aged less than 16 years or greater than 60 years 3. Pregnant women and lactating mothers 4. Unavailability of ventilator 5. Patients in whom endotracheal (ET) intubation is likely to be difficult 6. Have a Glasgow Coma Score (GCS) less than 12 at the time of recruitment 7. Ingested benzodiazepines in addition to OP 8. Have established renal or hepatic failure 9. Have indications for therapeutic diazepam 10. Patients who have respiratory failure requiring ventilatory support 11. Patients who have systolic blood pressure of less than 90 mmHg within 2 hours of administration of diazepam

Design outcomes

Primary

Measure	Time frame
Number of patients that exhibit possible adverse effects such as: 1. A decrease in level of consciousness (measured using the Glasgow Coma Scale) 2. Respiratory depression (measured by a respiratory rate less than 10, and a tidal volume of less than 180 ml/breath using a Wright's spirometer) 3. Hypotension (blood pressure [BP] less than 90/60 mmHg, or a drop of greater than 20 mmHg systolic in a normotensive patient, i.e. systolic BP less than 140 mmHg) Monitored every 15 minutes for the first 2 hours of administration of diazepam or placebo and then monitored hourly for the next 3 hours, and thereafter 4-hourly if the patient is clinically well, or more frequently if there are any clinical concerns.	—

Measure

Time frame

Number of patients that exhibit possible adverse effects such as: 1. A decrease in level of consciousness (measured using the Glasgow Coma Scale) 2. Respiratory depression (measured by a respiratory rate less than 10, and a tidal volume of less than 180 ml/breath using a Wright's spirometer) 3. Hypotension (blood pressure [BP] less than 90/60 mmHg, or a drop of greater than 20 mmHg systolic in a normotensive patient, i.e. systolic BP less than 140 mmHg) Monitored every 15 minutes for the first 2 hours of administration of diazepam or placebo and then monitored hourly for the next 3 hours, and thereafter 4-hourly if the patient is clinically well, or more frequently if there are any clinical concerns.

—

Secondary

Measure	Time frame
1. Number of patients that required ventilation 2. Changes in electroencephalogram (EEG), arterial blood gas (ABG), tidal volume and capnography 3. Patients who had seizures or died Monitored at baseline, 1 hour, 12 hours, 24 hours and daily. Continuous capnographic recording shall also be performed.	—

Countries

Sri Lanka

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026