Scopolamine Treatment for Patients With Organophosphate Poisoning
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ClinicalTrials.gov Identifier: NCT00389259 |
Recruitment Status :
Withdrawn
First Posted : October 18, 2006
Last Update Posted : April 5, 2011
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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 of death among people who commit suicide in developing countries. OPs poisoning also frequently occurs after accidental exposure to agricultural OPs and in children as a result of unintentional ingestion.
The use of competitive inhibitors of acetylcholine other than atropine for patient with organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the blood brain barrier is better than atropine, it has been suggested that scopolamine should be used OP poisoned patients who have central nervous system (CNS) manifestations. However there is controversy regarding its potential benefit in the treatment of organophosphate poisoning in humans. To the best of our knowledge there are no randomised controlled studies on the use of scopolamine in humans. This prospective randomised controlled study is aimed to determine whether adding scopolamine to the standard treatment of atropine and oximes in patients with CNS symptoms of OP poisoning improve the outcome.
Condition or disease | Intervention/treatment | Phase |
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Neurotoxicity Syndromes | Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized, Double Blind, Placebo-Controlled Study. |
Study Start Date : | October 2007 |
Estimated Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
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Experimental: A
IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h
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Drug: Placebo
IV placebo q4h |
Placebo Comparator: B
IV Look alike drug Q 4h
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Drug: Placebo
IV placebo q4h |
- Improvement in neurological status as measured by the Glasgow Coma Scale [ Time Frame: 1 week ]
- Duration of seizures. [ Time Frame: 1 week ]
- Number of days on ventilator [ Time Frame: 1 week ]
- Total cumulative dose of atropine [ Time Frame: 1 week ]
- Need for benzodiazepines [ Time Frame: 1 week ]
- Number of days in the ICU [ Time Frame: 2 weeks ]
- Adverse effects and complications [ Time Frame: 2 weeks ]
- Neurological assessment at discharge [ Time Frame: 2 weeks ]
- Neurological assessment 3 month after the exposure [ Time Frame: 3 month ]
- Neuro-cognitive assessment at 3 month [ Time Frame: 3 month ]
- Survival at 24 hours [ Time Frame: 24 hours ]
- Survival to discharge [ Time Frame: 4 weeks ]
- Number of days in hospital [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 2 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 2- 60 years
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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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389259
Israel | |
Rambam Hospital | |
Haifa, Israel |
Principal Investigator: | Eran Kozer, MD | Assaf-Harofeh Medical Center |
ClinicalTrials.gov Identifier: | NCT00389259 |
Other Study ID Numbers: |
70/04*1 |
First Posted: | October 18, 2006 Key Record Dates |
Last Update Posted: | April 5, 2011 |
Last Verified: | March 2010 |
Insecticides Organophosphate Scopolamine randomized control study Organophosphate or carbamate intoxication |
Neurotoxicity Syndromes Poisoning Organophosphate Poisoning Chemically-Induced Disorders Nervous System Diseases |