Scopolamine Treatment for Patients With Organophosphate Poisoning
关键词
抽象
描述
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.
日期
| 最后验证: | 02/28/2010 |
| 首次提交: | 10/16/2006 |
| 提交的预估入学人数: | 10/16/2006 |
| 首次发布: | 10/17/2006 |
| 上次提交的更新: | 04/03/2011 |
| 最近更新发布: | 04/04/2011 |
| 实际学习开始日期: | 09/30/2007 |
| 预计完成日期: | 11/30/2009 |
状况或疾病
干预/治疗
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: A IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h | |
| Placebo Comparator: B IV Look alike drug Q 4h |
资格标准
| 有资格学习的年龄 | 2 Years 至 2 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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) |
结果
主要结果指标
1. Improvement in neurological status as measured by the Glasgow Coma Scale [1 week]
2. Duration of seizures. [1 week]
3. Number of days on ventilator [1 week]
次要成果指标
1. Total cumulative dose of atropine [1 week]
2. Need for benzodiazepines [1 week]
3. Number of days in the ICU [2 weeks]
4. Adverse effects and complications [2 weeks]
5. Neurological assessment at discharge [2 weeks]
6. Neurological assessment 3 month after the exposure [3 month]
7. Neuro-cognitive assessment at 3 month [3 month]
8. Survival at 24 hours [24 hours]
9. Survival to discharge [4 weeks]
10. Number of days in hospital [4 weeks]
