Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

Completed · Phase 4

Conditions studied: Anticholinergics Toxicity

In brief

Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis, decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or benzodiazepines. Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly despite evidence of safety and efficacy. To demonstrate the utility and safety of physostigmine, the investigators propose a randomized clinical trial of physostigmine compared to benzodiazepine for antimuscarinic toxicity.

Key facts

Study ID

NCT03090620

Run by

University of Colorado, Denver

People needed

19

Starts

2017-03-30

Expected to finish

2020-08-31

Last updated by the study team

2021-08-23

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Colorado Anschutz Medical Campus, Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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