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

Information source: Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Deaths

Intervention: Pralidoxime (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sheri Kashmir Institute of Medical Sciences

Official(s) and/or principal investigator(s):
Showkat Gurcoo, MD, Study Director, Affiliation: SKIMS

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: mortality rate

Secondary outcome: duration of ventilation

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.

Eligibility

Minimum age: 14 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Sheri kashmir insititute of medical sciences, Srinagar, Srinagar Kashmir 190006, India
Additional Information

Related publications:

Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. Review.

Starting date: April 2012
Last updated: January 16, 2014

Page last updated: August 23, 2015

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