Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation (R2D2)

Geoffrey W Jara-Almonte

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Dexamethasone; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02725008

714220-1

Details and patient eligibility

About

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Full description

A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.

Enrollment: 99 patients

Sex: All

Ages: 18 months to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Exclusion criteria

• pregnancy
• severe chronic cardiac, respiratory, neurological or neuromuscular disease
• complete resolution of symptoms after one treatment of beta agonists
• severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit

Treatment:

Drug: Dexamethasone

Investigational

Experimental group

Description:

Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit

Treatment:

Drug: placebo

Drug: Dexamethasone