Dexamethasone dosing for children with acute asthma in the emergency department

Dosing of Steroids for Acute Asthma Given in the Emergency Department - a Pilot Randomised Feasibility Trial of Dexamethasone in Children

This study tests whether two different single doses of dexamethasone given in the emergency department help children aged 4–15 during an asthma attack.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 4 Years to 15 Years
• Sex: All
• Sponsor: Sheffield Children's NHS Foundation Trust (other)
• Locations: 1 site (Sheffield)
• Trial ID: NCT07402707 on ClinicalTrials.gov

What this trial studies

This randomized pilot compares two single oral doses of dexamethasone given in the ED to children aged 4–15 presenting with an asthma exacerbation. Investigators will compare the need for a repeat steroid prescription within two weeks after treatment and will record subsequent ED or GP visits and parent/child acceptability. Dexamethasone is used because it is well tolerated and can be given as a single dose rather than a multi-day course. As a feasibility trial, results will inform the design and size of a larger definitive study if needed.

Who should consider this trial

Good fit: Children aged 4–15 who present to the Sheffield Children's ED with an asthma exacerbation where oral steroids are recommended and whose family can use available language support are ideal candidates.

Not a fit: Children with life‑threatening asthma, first‑time wheeze, recent steroid use, concomitant stridor, known difficult asthma, other conditions requiring steroids, or current involvement in other research are not eligible and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could identify a single dexamethasone dose that reduces repeat steroid prescriptions and makes emergency treatment simpler and better tolerated for children.

How similar studies have performed: Previous trials and systematic reviews have found dexamethasone to be at least as effective as prednisolone for paediatric asthma exacerbations and better tolerated, so this dosing comparison builds on existing evidence.

Eligibility criteria

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 this trial is running

Sheffield

• Sheffield Children's NHS Foundation Trust — Sheffield, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Judith Gilchrist — Sheffield Children's NHS Foundation Trust
• Study coordinator: Meena Balasubramanian

Conditions: Acute Asthma, Dexamethasone