NCT03493503

Status Asthmaticus on the PICU; Intravenous Salbutamol

Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Asthma With Status Asthmaticus

Interventions

Type	Name	Description
DRUG	Salbutamol	Intravenous Salbutamol loading dose
DRUG	Sodium Chloride 0.9%	10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Timeline

• Start date: 2017-04-05
• Primary completion: 2019-05-21
• Completion: 2019-05-21
• First posted: 2018-04-10
• Last updated: 2020-07-30

Locations

1 site across 1 country: Netherlands