Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Ključne riječi
Sažetak
Datumi
| Posljednja provjera: | 05/31/2020 |
| Prvo podneseno: | 03/09/2017 |
| Predviđena prijava poslana: | 03/19/2017 |
| Prvo objavljeno: | 03/26/2017 |
| Posljednje ažuriranje poslano: | 06/01/2020 |
| Posljednje ažuriranje objavljeno: | 06/03/2020 |
| Stvarni datum početka studija: | 03/29/2017 |
| Procijenjeni datum primarnog završetka: | 07/30/2020 |
| Procijenjeni datum završetka studije: | 07/30/2020 |
Stanje ili bolest
Intervencija / liječenje
Drug: Physostigmine
Drug: Lorazepam
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| 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 |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 10 Years Do 10 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | 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 |
Ishod
Primarne mjere ishoda
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]
Sekundarne mjere ishoda
1. Safety and effectiveness of Physostigmine infusion in the setting of antimuscarinic toxidrome. [Before and after each bolus, and hourly for 4 hours]
