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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-03-01

Brief Summary

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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

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Detailed Description

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Conditions

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Laryngotracheobronchitis Croup

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A (oral dexamethasone )

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

Group Type ACTIVE_COMPARATOR

oral dexamethasone

Intervention Type DRUG

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

Group B (intramuscular dexamethasone )

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

Group Type ACTIVE_COMPARATOR

intramuscular dexamethasone

Intervention Type DRUG

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

Interventions

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oral dexamethasone

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

Intervention Type DRUG

intramuscular dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No