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OpenTrials
Completed

NCT Number: NCT06959407

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

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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Key information

Conditions

Laryngotracheobronchitis Croup Laryngeal Diseases Laryngitis Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral dexamethasone

Drug

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

intramuscular dexamethasone

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

Primary outcomes

  1. Settlement of symptoms of Croup

    Time frame: within 24 hours

    complete or partial settlement of symptoms i.e barking cough, inspiratory stridor, difficulty in breathing and hoarseness of voice.

Sponsors and collaborators

Lead sponsor

Arooj Khan

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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