Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
United States19 participantsStarted 2017-03-30
Plain-language summary
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.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus
Timeframe: Baseline, immediately before bolus
2
Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus
Timeframe: Immediately after bolus, up to 10 minutes post-Baseline
3
Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours
Timeframe: 4 hours
4
Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus
Timeframe: Baseline, immediately before bolus
5
Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus
Timeframe: Immediately after bolus, up to 10 minutes post-Baseline
6
Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours