Clinical Trial: Scopolamine Treatment for Patients With Organophosphate Poisoning

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 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.


Detailed Summary: 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.
Sponsor: Assaf-Harofeh Medical Center

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • Improvement in neurological status as measured by the Glasgow Coma Scale
  • Duration of seizures.
  • Number of days on ventilator


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Total cumulative dose of atropine
  • Need for benzodiazapines
  • 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 one month and 3 month
  • Survival at 24 hours
  • Survival to discharge
  • Number of days in hospital


Information By: Assaf-Harofeh Medical Center

Dates:
Date Received: October 17, 2006
Date Started: October 2007
Date Completion: December 2009
Last Updated: April 4, 2011
Last Verified: March 2010