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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
Sponsor:
Collaborator:
American Academy of Clinical Toxicology
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.


Condition or disease Intervention/treatment Phase
Anticholinergics Toxicity Drug: Physostigmine Drug: Lorazepam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physostigmine
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.
Drug: Physostigmine
Administration of physostigmine bolus followed by an infusion

Experimental: Lorazepam
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.
Drug: Lorazepam
Administration of lorazepam bolus followed by normal saline infusion




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: George S Wang, MD 303-724-9967 george.wang@childrenscolorado.org
Contact: Kathleen Grice 303-724-3285 kathleen.grice@childrenscolorado.org

Locations
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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    george.wang@childrenscolorado.org   
Contact: Kathleen Grice    303-724-3285    kathleen.grice@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
American Academy of Clinical Toxicology
Investigators
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Principal Investigator: George S Wang, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03090620     History of Changes
Other Study ID Numbers: 16-1730
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lorazepam
Physostigmine
Cholinergic Antagonists
Muscarinic Antagonists
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Miotics