drugset / Trial / NCT03493503

Status Asthmaticus on the PICU; Intravenous Salbutamol

NCT03493503

Phase 4 Completed 58 enrolled Erasmus Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.

Timeline

Start
2017-04-05
Primary completion
2019-05-21
Completion
2019-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 15 ug/kg Intravenous

Indications