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

S

Sheri Kashmir Institute of Medical Sciences

Status and phase

Completed
Phase 1

Conditions

Deaths

Treatments

Drug: Pralidoxime

Study type

Interventional

Funder types

Other

Identifiers

NCT02040350
U1111-1151-9883

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

14 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo was given to compare the effects
Treatment:
Drug: Pralidoxime
Pralidoxime
Active Comparator group
Description:
Pralidoxime for treating organophosphorous poisoning patients
Treatment:
Drug: Pralidoxime

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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