Trial intelligence / Profile preview

Low-Dose Atropine and Bradycardia in Infants

NCT01819064Phase 4

Key facts

Status
Completed
Start
Feb 2013
Primary completion
Jul 2013
Countries
1
Sponsor
University at Buffalo
Modality
Classical Binding Small Molecules
Conditions
bradycardia
01

Overview

Phase 4, open-label, single-arm trial of atropine in bradycardia, sponsored by University at Buffalo. Primary endpoint: Incidence of Bradycardia at 5 minutes. Started Feb 2013; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Experimental

    Infants <15kg receiving 0.005 mg/kg atropine

03

Who it enrols

Infants 0-2 years old, weighing <15kg (and <95th percentile), ASA I-II, undergoing elective surgery. Excludes history of heart disease, arrhythmia predisposition, use of heart rate influencing meds or routine anti-cholinergics, anticipated succinylcholine use, rapid sequence intubation, or known difficult airway.

04

Endpoints

Primary

  • Incidence of Bradycardia

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