Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome (TAAT)
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|ClinicalTrials.gov Identifier: NCT03090620|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Anticholinergics Toxicity||Drug: Physostigmine Drug: Lorazepam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial Comparing Physostigmine vs Lorazepam for Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome|
|Actual Study Start Date :||March 30, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.
Administration of physostigmine bolus followed by an infusion
Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.
Administration of lorazepam bolus followed by normal saline infusion
- Comparison of RASS score between physostigmine and lorazepam. [ Time Frame: Before and after each bolus, and hourly for 5 hours ]Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol.
- Comparison of the effectiveness in control of delirium between physostigmine and lorazepam. [ Time Frame: Before and after each bolus, and hourly for 5 hours ]Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study.
- Safety and effectiveness of Physostigmine infusion in the setting of antimuscarinic toxidrome. [ Time Frame: Before and after each bolus, and hourly for 4 hours ]Evaluation of clinical antimuscarinic symptoms, along with presence of any adverse effects, during the infusion to report tolerability, safety profile, and effectiveness of the infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090620
|Contact: George S Wang, MDfirstname.lastname@example.org|
|Contact: Kathleen Griceemail@example.com|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus, Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: George S Wang 303-724-9967 firstname.lastname@example.org|
|Contact: Kathleen Grice 303-724-3285 email@example.com|
|Principal Investigator:||George S Wang, MD||University of Colorado, Denver|