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

January 28, 2026 updated by: Arooj Khan
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Khyber Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (oral dexamethasone )
Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose
Drug: oral dexamethasone
Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arooj Khan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 410/DME/KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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