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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Group A (Ketamine) * Nebulised ketamine 1 mg/kg per dose every 6 hours for 24 hours (4 doses total). * Ketamine solution (e.g. 10 mg/mL) diluted with 0.9% saline to a total volume of 3-5 mL. Nebulisation will be delivered via jet nebuliser with oxygen flow 6-8 L/min using a mask. A dose will be considered complete when the nebuliser chamber is dry.
Nebulised 0.9% saline, 3-5 mL per dose, every 6 hours for 24 hours. Nebulisation will be delivered via jet nebuliser with oxygen flow 6-8 L/min using a mask. A dose will be considered complete when the nebuliser chamber is dry.
Sultan Qaboos University Hospital
Muscat, Oman
Change in Pediatric Respiratory Assessment Measure (PRAM) score.
Mean difference in the change in Pediatric Respiratory Assessment Measure (PRAM) score within 60 minutes of treatment between the nebulized ketamine and placebo groups. The PRAM is a validated clinical asthma severity score ranging from 0 to 12, where higher scores indicate more severe respiratory distress (a worse outcome) and a greater reduction indicates clinical improvement.
Time frame: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)
Proportion of participants requiring non-invasive ventilation (NIV) or mechanical ventilation
Number and percentage of participants who require escalation to non-invasive ventilation (NIV) or invasive mechanical ventilation during the treatment period.
Time frame: Up to 24 hours after first dose
Length of stay in the HDU/PICU
Duration of stay in the High Dependency Unit (HDU) or Pediatric Intensive Care Unit (PICU), measured in days.
Time frame: Through study completion, an average of 5 days
Change in heart rate
Change in heart rate (beats per minute) from baseline, monitored to assess therapeutic response and possible hemodynamic effects of the study medication. Unit: beats per minute
Time frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
Change in respiratory rate
Change in respiratory rate (breaths per minute) from baseline as a marker of clinical improvement. Unit: breaths per minute
Time frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
Change in oxygen saturation
Change in peripheral oxygen saturation (SpO2, %) from baseline as a marker of clinical improvement. Unit: percentage (%)
Time frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
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