Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
关键词
抽象
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 03/09/2017 |
| 提交的预估入学人数: | 03/19/2017 |
| 首次发布: | 03/26/2017 |
| 上次提交的更新: | 06/01/2020 |
| 最近更新发布: | 06/03/2020 |
| 实际学习开始日期: | 03/29/2017 |
| 预计主要完成日期: | 07/30/2020 |
| 预计完成日期: | 07/30/2020 |
状况或疾病
干预/治疗
Drug: Physostigmine
Drug: Lorazepam
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Physostigmine Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours. | Drug: Physostigmine Administration of physostigmine bolus followed by an infusion |
| Experimental: Lorazepam Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours. | Drug: Lorazepam Administration of lorazepam bolus followed by normal saline infusion |
资格标准
| 有资格学习的年龄 | 10 Years 至 10 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age >=10 and < 18 years - Present to the Emergency Department or Intensive Care Unit for an antimuscarinic toxidrome from either a pharmaceutical agent such as antihistamine overdose, or natural toxins or products such as Datura stramonium - Antimuscarinic toxidrome will be defined with at least one central nervous system agitation effect (agitation, delirium, visual hallucinations, mumbling incomprehensible speech), and at least 2 peripheral nervous system adverse effect (mydriasis, dry mucus membranes, dry axillae, tachycardia, decreased bowel sounds). - Patients will also be required to have a RASS score of +2 to +4 on initial assessment. Exclusion Criteria: - History of seizures or seizure during acute clinical course - History of asthma or wheezing during clinical course Bradycardia (Heart Rate <60) - Concomitant use of atropine or choline ester or depolarizing neuromuscular blocker during present illness and hospital course - Diabetes gangrene, known intestinal obstruction or urogenital tract, vagotonic state - QRS interval > 120 ms on electrocardiogram - Known to be pregnant at the time of enrollment - Known ward of the state |
结果
主要结果指标
1. Comparison of RASS score between physostigmine and lorazepam. [Before and after each bolus, and hourly for 5 hours]
2. Comparison of the effectiveness in control of delirium between physostigmine and lorazepam. [Before and after each bolus, and hourly for 5 hours]
次要成果指标
1. Safety and effectiveness of Physostigmine infusion in the setting of antimuscarinic toxidrome. [Before and after each bolus, and hourly for 4 hours]
