Status:
WITHDRAWN
Scopolamine Treatment for Patients With Organophosphate Poisoning
Lead Sponsor:
Assaf-Harofeh Medical Center
Collaborating Sponsors:
Israeli MOH
International Diabetes Federation
Conditions:
Neurotoxicity Syndromes
Eligibility:
All Genders
2-60 years
Phase:
NA
Brief Summary
Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause o...
Detailed Description
Objective: to determine whether adding scopolamine to the standard treatment of atropine and oximes improve the outcome of patients with OP poisoning and CNS manifestations. Design: A multi-center, ra...
Eligibility Criteria
Inclusion
- Age: 2- 60 years
- At least two of the following three criteria:
- Known exposure to an organophosphate or carbamate insecticide in the last 72 hours.
- Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix
- Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range )
- CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria
- Major criteria for CNS involvement:
- Seizures
- Extrapyramidal or Parkinson like symptoms
- Decreased level of consciousness (GCS\< 12)
- Minor criteria for CNS involvement:
- GCS 14-12
- Confusion
- Hallucinations
Exclusion
- Hypersensitivity to scopolamine
- Glaucoma, narrow-angle (angle-closure)
- Tachyarrhythmias, congestive heart failure
- Obstructive gastrointestinal disease
- Myasthenia Gravis
- Reflux esophagitis
- Ulcerative colitis
- Known obstructive uropathy
- Pregnancy
- Patient or legal guardian unable to give informed consent (see comment under ethics)
- Severe co-morbidity (multi-trauma, advanced cancer, etc)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00389259
Start Date
October 1 2007
End Date
December 1 2009
Last Update
April 5 2011
Active Locations (1)
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1
Rambam Hospital
Haifa, Israel