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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

Tracking Information
First Submitted Date  ICMJE March 10, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE March 30, 2017
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03090620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Official Title  ICMJE A Randomized Trial Comparing Physostigmine vs Lorazepam for Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anticholinergics Toxicity
Intervention  ICMJE
  • Drug: Physostigmine
    Administration of physostigmine bolus followed by an infusion
  • Drug: Lorazepam
    Administration of lorazepam bolus followed by normal saline infusion
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Physostigmine
  • 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.
    Intervention: Drug: Lorazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2017)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: George S Wang, MD 303-724-9967 george.wang@childrenscolorado.org
Contact: Kathleen Grice 303-724-3285 kathleen.grice@childrenscolorado.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03090620
Other Study ID Numbers  ICMJE 16-1730
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE American Academy of Clinical Toxicology
Investigators  ICMJE
Principal Investigator: George S Wang, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP