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Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?

Study Effect of WHO Recommended Dose of Pralidoxime in the Treatment of Organophosphorus Poisoning

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02040350
Enrollment
100
Registered
2014-01-20
Start date
2012-04-30
Completion date
2013-11-30
Last updated
2014-01-20

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

Conditions

Deaths

Keywords

Pralidoxime, atropine, organophosphorous poisoning.

Brief summary

To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

Detailed description

The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.

Interventions

Pralidoxime was compared to placebo to study the effects of the drug on mortatlity

Sponsors

Sheri Kashmir Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

history of alleged organophosphorus intake age \> 14 years \< 60 years clinical signs and symptoms of organophosphorus poisoning.

Exclusion criteria

\< 14 years or \> 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses ≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.

Design outcomes

Primary

MeasureTime frame
mortality rateupto one year

Secondary

MeasureTime frame
duration of ventilationupto one year

Other

MeasureTime frame
duration of ICU stayupto one year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026