864
Participants
Start Date
December 13, 2018
Primary Completion Date
January 7, 2025
Study Completion Date
May 21, 2025
Oral dexamethasone
Two doses of oral dexamethasone, 0.6 mg/kg (maximum single dose 10 mg). One at the time of emergency department enrolment immediately prior to first nebulized treatment and one at approximately 24 hour later
Nebulized Epinephrine
Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
Oral placebo
Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.
Nebulized normal saline
Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
MDI Epinephrine
Two doses of Epinephrine given by MDI plus spacer at 625 mcg (5 actuations of 125mcg) 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
MDI placebo
Two doses of inhaled placebo given by MDI plus spacer, 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
Starship Children's Hospital, Auckland
Kidz First Hospital, Auckland
Monash Medical Centre, Melbourne
Waikato Hospital, Hamilton
Women and Children's Hospital, Adelaide
Perth Children's Hospital, Perth
Children's Hospital of Alberta, Calgary
Stollery Children's Hospital, Edmonton
Childrens Hospital at London Health Sciences, London
Children's Hospital of Eastern Ontario, Ottawa
CHU Sainte-Justines Hospital, Montreal
Children's Hospital of Winnipeg, Sherbrook
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Children's Hospital Research Institute of Manitoba
OTHER
Research Manitoba
OTHER
Women and Children's Health Research Institute, University of Alberta
UNKNOWN
Alberta Children's Hospital Research Institute
OTHER
The Hospital for Sick Children
OTHER
Department of Pediatrics, Western University
UNKNOWN
St. Justine's Hospital
OTHER
Children's Hospital of Eastern Ontario
OTHER