A Phase 2 interventional study of Ketamine (1 mg/kg) and Placebo in Asthma Acute and Exacerbation of Allergic Asthma, sponsored by Sultan Qaboos University. Not yet recruiting at 1 site in Oman. Open to participants aged 1 Year to 13 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Sultan Qaboos University · Phase 2, Interventional, and Treatment
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Sultan Qaboos University is the lead sponsor of 50 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nebulised ketamine 1 mg/kg per dose every 6 hours for 24 hours (4 doses total).
Drug: Ketamine (1 mg/kg)
Nebulised 0.9% saline, 3-5 mL per dose, every 6 hours for 24 hours.
Drug: Placebo
Drug page: Ketamine
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.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) for all primary and secondary outcome measures will be made available to qualified researchers upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available beginning 6 months and ending 5 years following publication of the main results.
Access criteria: Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to Zlawati@squ.edu.om. Requestors will need to sign a data access agreement.
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
Of 61 non-industry phase 2 interventional studies under Asthma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's planned 23 months is below that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
Sultan Qaboos University