Dosing of Steroids for Acute Asthma Given in the Emergency Department - a Pilot Randomised Feasibility Trial of Dexamethasone in Children
Recruiting · NCT07402707 · Interventional (participants receive a specific treatment) · Lead sponsor: Sheffield Children's NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Steroids given by mouth are an important first line treatment for children presenting with asthma attacks. Dexamethasone is the steroid used in some emergency departments (EDs) because of the need for a single dose and as it is well tolerated. The dose of dexamethasone in treating asthma attacks is not clearly established. This study compares two different doses of dexamethasone in children presenting with an asthma attack. Investigators will compare the effect of two different doses in reducing the need for a repeat prescription of steroids for an asthma attack in the 2 weeks after the first treatment. The investigators will also look at how often children attend the ED or their GP after being given treatment as well as the acceptability to parents and children. Although this study may provide an answer to the question of whether the different doses have the same effect, the investigators believe that a larger study will be needed to provide robust generalisable evidence, as well as to ensure that the outcomes are truly what matters to parents, children and healthcare professionals. This study will provide valuable information to enable a larger study to be undertaken.
Who can take part
Inclusion criteria
- Children aged 4-15 years (inclusive) presenting to the ED with an asthma exacerbation, where oral steroids are recommended by Trust/National guidelines.
- Children whose parents/carers do not speak English will also be eligible provided they speak one of the common languages where an interpreter and Information Sheets are available (Slovakian, Arabic and Urdu).
Exclusion criteria
- Children who have been treated with oral or IV steroids in the last 2 weeks.
- Hypersensitivity to the study drug.
- Children who have concomitant stridor.
- First episode of wheezing (not previously diagnosed as asthma).
- Children with known difficult asthma who receive longer courses of steroids as standard.
- Life threatening episode of asthma.
- Children with other conditions that require them to have steroids when unwell.
- Children who are involved in current research or have recently been involved in research prior to recruitment
Where it is running
1 location listed.
- Sheffield Children's NHS Foundation Trust - Sheffield, United Kingdom