None listed
Conditions
Interventions
Group A Type of group
Amiodarone l.V. HCI at a dose of 1 mg / kg for 10 minutes as a slow bolus infusion, followed by a rest for 5 minutes. To maintain the blind, three placebo infusions will be administered below. Each of these infusions will be given in slow bolus for 10 minutes followed by a rest of 5 minutes (1 mg / kg in total in the first hour).
Group name:Group C Type of group
Amiodarone l.V. HCI in four equal divided doses of 2.5 mg / kg. Each dose is administered for 10 minutes as a slow bolus infusion followed by a 5 minute rest (10 mg / kg in total in the first hour).
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Pediatric male and female patients between 30 days and 16 years of age, who suffer any incessant supraventricular and / or ventricular arrhythmia, patients suffering from TEN, if the nodal rate is> 95th percentile for age (see Appendix III) , Heart rates in children) • Weight between> 2 kg and 8 years of age • Immediate availability of transcutaneous pacemaker
Exclusion criteria
Exclusion criteria: • Use of amiodarone in the previous three months • History of optic neuritis / optic neuropathy • Antecedents of transplant • Confirmed hypersensitivity to amiodarone or its components (eg iodine) • Cardiogenic shock or acute pulmonary edema • Second or third degree AV block, unless a pacemaker is available • Confirmation or suspicion of clinically significant hepatic impairment • Current enrollment in other research studies, unless they involve a surgical device or technique • Imminent death from other causes / active resuscitation from cardiac arrest • Confirmed congenital long Q-T syndrome • Torsades de pointes • Pulseless electrical activity • Known arrhythmias induced by drug, metabolically, or by electrolytes • Establishment of hypothermic treatment for arrhythmia at <35 ° C body temperature in the 3 hours prior to admission in the study (induced hypothermia for surgery is allowed) • Pregnancy • Confirmation or suspected toxicity of antiarrhythmic drugs • Patients undergoing extracorporeal membrane oxygenation treatment (EGMO)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• return to sustained sinus rhythm (> 10 minutes), or • in patients with TEN, a 20% reduction in baseline heart rate, and a heart rate ten minutes. Measure:Time to success Timepoints:More than 10 minutes after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Time until the cessation of arrhythmia Timepoints:During the treatment ; Outcome name:Clinical evaluation Measure:Time to the first rescue bolus Timepoints:During the treatment ; Outcome name:Clinical evaluation Measure:Frequency of patients whose arrhythmias stop Timepoints:During the treatment ; Outcome name:Number of rescue boluses required Measure:Frequency of patients requiring rescue bolus and Average number of rescue boluses Timepoints:At the end of the treatment ; Outcome name:Recurrence for patients with TEN is defined as an increase> 10 beats in the heart rate above the level of heart rate required to define success of> 30 seconds in duration Measure:Frequency of patients with recurrent arrhythmia of> 30 seconds each hour of the remaining 48 hours of blind treatment Timepoints:Every hour of the remaining 48 hours of blind treatment ; Outcome name:Clinical evaluation Measure:Hospitalization rate due to recurrent arrhythmia during the observation period of 30 days after the discontinuation of the blind treatment, oral treatment has been initiated or not Timepoints:During the observation period of 30 days after the discontinuation of the blind treatment ; Outcome name:Discontinuations due to lack of efficacy / experiences or adverse events Measure:Treatment failure Timepoints:At the ed of the treatment | — |
Outcome results
None listed