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Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

Ainult registreeritud kasutajad saavad artikleid tõlkida
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Link salvestatakse lõikelauale
StaatusVärbamine
Sponsorid
University of Colorado, Denver
Kaastöötajad
American Academy of Clinical Toxicology

Märksõnad

Abstraktne

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.

Kuupäevad

Viimati kinnitatud: 05/31/2020
Esmalt esitatud: 03/09/2017
Hinnanguline registreerumine on esitatud: 03/19/2017
Esmalt postitatud: 03/26/2017
Viimane värskendus on esitatud: 06/01/2020
Viimati värskendus postitatud: 06/03/2020
Õppe tegelik alguskuupäev: 03/29/2017
Eeldatav esmane lõpetamise kuupäev: 07/30/2020
Eeldatav uuringu lõpetamise kuupäev: 07/30/2020

Seisund või haigus

Anticholinergics Toxicity

Sekkumine / ravi

Drug: Physostigmine

Drug: Lorazepam

Faas

Faas 4

Käerühmad

ArmSekkumine / ravi
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

Abikõlblikkuse kriteeriumid

Õppimiseks sobivad vanused 10 Years To 10 Years
Uuringuks kõlblikud soodAll
Võtab vastu tervislikke vabatahtlikkeJah
Kriteeriumid

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

Tulemus

Esmased tulemusnäitajad

1. Comparison of RASS score between physostigmine and lorazepam. [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. [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.

Sekundaarsed tulemusmõõdud

1. Safety and effectiveness of Physostigmine infusion in the setting of antimuscarinic toxidrome. [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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