Title

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

    Phase 3
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    3243
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.
Study Started
Dec 11
2020
Primary Completion
Jun 30
2024
Anticipated
Study Completion
Jun 30
2024
Anticipated
Last Update
Sep 29
2023

Drug Magnesium Sulfate

Treatment in addition to standard therapy

Drug Nimodipine

Treatment in addition to standard therapy

Magnesium sulfate Active Comparator

Standard therapy plus magnesium sulfate

Control No Intervention

Standard therapy

Nimodipine Active Comparator

Standard therapy plus nimodipine

Criteria

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)
No Results Posted