Sultan Qaboos University Hospital
Muscat, Oman
Location contact
Raghad Al Abdawani
CONTACT
Raghad Al Abdwani
SUB_INVESTIGATOR
Zahraa Al Lawati
PRINCIPAL_INVESTIGATOR
Zahraa Ali Al Lawati
CONTACT
NCT Number: NCT07728851
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.
Trial opening soon.
Get Notified1 year–13 year
All sexes
Interventional
Phase 2
Muscat, Oman
Raghad Al Abdawani
CONTACT
Raghad Al Abdwani
SUB_INVESTIGATOR
Zahraa Al Lawati
PRINCIPAL_INVESTIGATOR
Zahraa Ali Al Lawati
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group A (Ketamine)
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.
Time frame: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)
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: Up to 24 hours after first dose
Number and percentage of participants who require escalation to non-invasive ventilation (NIV) or invasive mechanical ventilation during the treatment period.
Time frame: Through study completion, an average of 5 days
Duration of stay in the High Dependency Unit (HDU) or Pediatric Intensive Care Unit (PICU), measured in days.
Time frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
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 (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 peripheral oxygen saturation (SpO2, %) from baseline as a marker of clinical improvement.
Unit: percentage (%)
Contact information is provided by the study sponsor or research team.
Sultan Qaboos University
Other
Effectiveness and Safety of Nebulized Ketamine in Severe Pediatric Asthma: a Phase-2, Double-blind, Randomized, Placebo-controlled Pilot Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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