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Scopolamine Treatment for Patients With Organophosphate Poisoning

Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neurotoxicity Syndromes

Intervention: Placebo (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Assaf-Harofeh Medical Center

Official(s) and/or principal investigator(s):
Eran Kozer, MD, Principal Investigator, Affiliation: Assaf-Harofeh Medical Center

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 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.

Clinical Details

Official title: Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized, Double Blind, Placebo-Controlled Study.

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

Primary outcome:

Improvement in neurological status as measured by the Glasgow Coma Scale

Duration of seizures.

Number of days on ventilator

Secondary outcome:

Total cumulative dose of atropine

Need for benzodiazepines

Number of days in the ICU

Adverse effects and complications

Neurological assessment at discharge

Neurological assessment 3 month after the exposure

Neuro-cognitive assessment at 3 month

Survival at 24 hours

Survival to discharge

Number of days in hospital

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, randomized, double blind, placebo controlled study. Setting: Emergency

Departments & Intensive Care Units in Israel. Participants: Patients 2 - 60 years old with

acute OP poisoning and CNS manifestations. Interventions: In addition to standard treatment with atropine and obidoxime, eligible patients will be randomly assigned to one of two treatment groups, scopolamine group, and placebo group (both given in the same volume). Scopolamine will be given IM or IV in a dose of 0. 25mg for adults and 0. 006mg/kg for children every 4 hours. At least three doses of scopolamine (or placebo) will be given. The medical staff will be blinded to the treatment given. Main outcome measures: Improvement in neurological status, duration of seizures and number of days on ventilator. Data analysis: The main outcome measures, will be compared using the Student's t-test or the Mann-Whitney tests as appropriate. The *2 or Fisher Exact tests, as appropriate, will be used for comparisons of categorical variables. We will use multiple logistic regression to examine the extent to which variables predict success or failure of the treatment.

Eligibility

Minimum age: 2 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 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)

Locations and Contacts

Rambam Hospital, Haifa, Israel
Additional Information

Starting date: October 2007
Last updated: April 4, 2011

Page last updated: August 23, 2015

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