Health Trials

Nebulized Ketamine for Severe Asthma Attacks in Children

ConditionsAsthma AcuteExacerbation of Allergic Asthma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ketamine (1 mg/kg)

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A (Ketamine)Active comparator 1 intervention
Group B: Group B (Placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sultan Qaboos University

Lead sponsor

Source ClinicalTrials.gov

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