Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

Study Overview
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Brief Summary
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This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.

Official Title
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Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines

Conditions
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Anticholinesterase Insecticide Poisoning, Pesticide Poisoning

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Nimodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine. Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp. Patients who ingest combination products containing OP or carbamate insecticides will also be included. Inhibited blood cholinesterase activity as shown by routine clinical bedside test Exclusion Criteria: Children aged <16 years. Patients who do not require atropine and have not had it prior to presentation during this episode. Normal blood cholinesterase activity Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response) Known occupational and homicidal poisoning Past medical history of severely impaired renal function Hypersensitivity to magnesium and its salts Patients who have had a myocardial infarction or unstable angina in the last month Patients with traumatic subarachnoid haemorrhage Lack of informed consent (unaccompanied unconscious patients and others)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard therapy | |
| Active Comparator: Magnesium sulfate<br>Standard therapy plus magnesium sulfate | Drug: Magnesium Sulfate<br>* Treatment in addition to standard therapy<br>|
| Active Comparator: Nimodipine<br>Standard therapy plus nimodipine | Drug: Nimodipine<br>* Treatment in addition to standard therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Whether dead or alive at hospital discharge | through to hospital discharge, median 1 week |