Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup

Arooj Khan

Status: Completed

Conditions: Laryngotracheobronchitis; Croup

Treatments: Drug: intramuscular dexamethasone; Drug: oral dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06959407

410/DME/KMC

Details and patient eligibility

About

Croup (laryngotracheobronchitis) is a viral infection of the upper airway that causes throat swelling, leading to a barking cough, stridor, and hoarseness. It mainly affects children aged 6 months to 12 years, peaking at around 2 years. Most cases are mild and self-limiting. Emergency treatments include cool mist, nebulized epinephrine, and steroids. Steroid therapy, particularly dexamethasone (oral or intramuscular), is commonly used, with recent studies suggesting intramuscular dexamethasone may be more effective. However, most research has focused on hospitalized patients, and there is a lack of local data for mild cases. This study aims to address that gap and improve patient counseling and future research

Enrollment: 200 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age 2 to 12 years
• Both genders
• Diagnosed with croup as operational definitions

Exclusion criteria

• Patients with chronic pulmonary disease like tuberculosis,
• Allergy or contraindication of corticosteroid (history of tuberous sclerosis, history of varicella infection during the past three weeks), to corticosteroids,
• history of corticosteroid administration during the last four weeks,
• foreign body
• patients with immunodeficiency disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Group A (oral dexamethasone )

Active Comparator group

Description:

Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose

Treatment:

Drug: oral dexamethasone

Group B (intramuscular dexamethasone )

Active Comparator group

Description:

Patients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose

Treatment:

Drug: intramuscular dexamethasone