Nebulized Ketamine for Severe Asthma Attacks in Children

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-13
SponsorSultan Qaboos University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Known allergy or adverse reaction to ketamine

Significant hemodynamic instability

Systemic hypertension >95th percentile for age

Cardiac arrhythmias

Trial design

Treatments tested in this trial

  • Ketamine (1 mg/kg)
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators