Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389259
Status:
WITHDRAWN
Last Update Posted:
2011-04-05
First Post:
2006-10-17
Brief Title:
Scopolamine Treatment for Patients With Organophosphate Poisoning
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized Double Blind Placebo-Controlled Study
Status:
WITHDRAWN
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 025mg for adults and 0006mgkg 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 Students 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None