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Nebulized Ketamine for Severe Asthma Attacks in Children
Nebulized Ketamine for Severe Asthma Attacks in Children

NCT07728851

Not Yet RecruitingPhase 2

Sponsor: Sultan Qaboos University

Conditions: Asthma Acute, Exacerbation of Allergic Asthma

Interventions: Ketamine (1 mg/kg), Placebo

Countries: Oman

This is a double-blinded, randomised, placebo-controlled trial enrolling 60 children aged 1 to 13 years with severe asthma exacerbation. All participants will receive standard therapy. Children not responding to standard therapy will be randomised to intervention arms. Randomization will occur in a 1:1 ratio using a computer-generated Excel sequence with permuted blocks of four, stratified by age (1-5 and 6-13 years). Patients will receive either nebulized ketamine (1 mg/kg every 6 hours for 24 hours) or 0.9% normal saline placebo. Randomization codes will be maintained by the hospital pharmacy, which will prepare identical numbered packs. During working hours, the pharmacist will dispense the allocated medication; at nights and weekends, pre-prepared packs will be stored securely in the PHDU/PICU under the supervision of the nursing in-charge. Blinding will be maintained for patients, clinicians, and outcome assessors. PRAM scores will be recorded at baseline and at 20, 60, 90, and 120 minutes post-dose. The primary outcome is pediatric respiratory assessment measure (PRAM) score change. Secondary outcomes include need for NIV or intubation and HDU/PICU length of stay.

Eligibility overview

Sex: ALL

Age: 1 Year to 13 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Children aged 1 to 13 years.
* Diagnosis of severe asthma exacerbation (PRAM score 8-12)
* Prior treatment with standard first-line management (beta-2 agonist, corticosteroid, magnesium sulfate)

Exclusion Criteria:

* Known allergy or adverse reaction to ketamine
* Significant hemodynamic instability
* Systemic hypertension \>95th percentile for age
* Cardiac arrhythmias
* Congestive heart failure
* Obstructive sleep apnea with AHI \>5
Locations (1)
  • Muscat, Oman