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Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

NCT03090620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-08-23

Study results available
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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.

Conditions

  • Anticholinergics Toxicity

Interventions

DRUG

Physostigmine

Administration of physostigmine bolus followed by an infusion

DRUG

Lorazepam

Administration of lorazepam bolus followed by normal saline infusion

Sponsors & Collaborators

  • American Academy of Clinical Toxicology

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • George S Wang, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2020-07-31
Completion
2020-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090620 on ClinicalTrials.gov