The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers

Bispebjerg Hospital42 enrolled

Overview

The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Organophosphate Poisoning

Interventions

OrganophosphateOTHER

Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous

PlaceboOTHER

Multineem, WHO Class U: Unlikely to present acute hazard in normal use

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * male * minimum age 18 years * hand pressured backpack sprayer usage * used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification Exclusion Criteria: * usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho) * unwilling to stay pesticide-free seven days prior to each of the two spray sessions * medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)

Outcomes

Primary Outcomes

Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up

Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning.

Time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session

Change in Plasma Cholinesterase (PchE) activity from baseline to follow up

PchE activity was measured with a blood test using a Test-mate Che Cholinesterase System (Model 400) with a PchE Plasma Cholinesterase Assay Kit (Model 470).

Time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session

Data from ClinicalTrials.gov

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