Phase 4
N=19
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Anticholinergics Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT03090620 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus — 1.5; 1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Physostigmine (Drug); Lorazepam (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus |
1.5; 1 | — |
| PRIMARY Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus |
0; 1 | — |
| PRIMARY Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours |
0; 0.25 | — |
| PRIMARY Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus |
9; 9 | — |
| PRIMARY Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus |
4; 10 | — |
| PRIMARY Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours |
2; 10 | — |
| SECONDARY Safety and Effectiveness of Physostigmine Infusion in the Setting of Antimuscarinic Toxidrome. |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >=10 and 120 ms on electrocardiogram
- Known to be pregnant at the time of enrollment
- Known ward of the state
Data sourced from ClinicalTrials.gov (NCT03090620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.