Nebulized Ketamine for Children With Severe Asthma Attacks
Tests nebulized ketamine against a placebo in children with severe asthma attacks.
Plain-language title generated from the registry record
Registry title: Nebulized Ketamine for Severe Asthma Attacks in Children
Key facts
- Where
- Muscat, OmanSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 13 years old?
Source: NCT07728851, who can take part
Where in Oman
- Sultan Qaboos University HospitalMuscat, OmanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sultan Qaboos University
- Trial code
- NCT07728851
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
Effectiveness and Safety of Nebulized Ketamine in Severe Pediatric Asthma: a Phase-2, Double-blind, Randomized, Placebo-controlled Pilot 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.
Inclusion: 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: Known allergy or adverse reaction to ketamine; Cardiac arrhythmias; Congestive heart failure; Systemic hypertension >95th percentile for age; Significant hemodynamic instability; Obstructive sleep apnea with AHI >5.