Nebulized Ketamine for Severe Asthma Attacks in Children (NCT07728851) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nebulized Ketamine for Severe Asthma Attacks in Children
Oman60 participantsStarted 2027-01-01
Plain-language summary
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.
Who can participate
Age range
1 Year – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing nebulized ketamine specifically for severe asthma attacks in children and is still in Phase 2, what does my doctor think is currently known about its safety profile in kids, and what gaps does this trial still need to fill?
2The trial measures improvement using something called the PRAM score — can my doctor explain what that score tracks and whether it's a good reflection of how my child actually feels and breathes during a severe attack?
3Since the trial is not yet recruiting, my child may need treatment soon — what standard treatments would be used in the meantime, and how do those compare to what this trial is testing?
4Ketamine is already used in some emergency settings, but nebulizing it for asthma attacks in children is still being studied — can my doctor walk me through what the known risks of inhaled ketamine are for a child my child's age?
5If this trial eventually opens and my child might be eligible, what would participation actually look like during a severe asthma attack — would my child be enrolled in the ER, and how would that affect the care they receive in that urgent moment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pediatric Respiratory Assessment Measure (PRAM) score.
Timeframe: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)