Scopolamine Treatment for Patients With Organophosphate Poisoning

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Collaborators: International Diabetes Federation; Israeli MOH
• Treatments: Butylscopolammonium Bromide; Scopolamine Hydrobromide

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)