Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT03090620
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT03090620
Study Brief:
Protocol Section:
NCT03090620