Asthma AcutePhase 2NCT07728851
Nebulized Ketamine for Severe Asthma Attacks in Children
A Phase 2 study testing Ketamine (1 mg/kg) in people with Asthma Acute and Exacerbation of Allergic Asthma, run by Sultan Qaboos University at 1 site in Oman.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Asthma Acute, Exacerbation of Allergic Asthma
- What is being tested?
- Ketamine (1 mg/kg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteOman
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site
Sultan Qaboos University Hospital
Muscat
Zahraa Ali Al Lawati, +96892347374, zlawati@squ.edu.om
Raghad Al Abdawani, +96899203929, raghadabdwani@gmail.com
About this study
Official title: 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.
- Conditions
- Asthma Acute, Exacerbation of Allergic Asthma
- Being tested
- Ketamine (1 mg/kg), Placebo
- Keywords
- Asthma, Ketamine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Ketamine) | Active comparator | Nebulised ketamine 1 mg/kg per dose every 6 hours for 24 hours (4 doses total). Receives: Drug: Ketamine (1 mg/kg) |
| Group B (Placebo) | Placebo comparator | Nebulised 0.9% saline, 3-5 mL per dose, every 6 hours for 24 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase-2 pilot designed to estimate effect size/variance, characterise safety, and assess feasibility. A total of 60 participants (30 per arm) will provide adequate precision around the mean difference in PRAM change and around AE rates to inform a future definitive phase-3 trial. Sample size of 60 (30 in each arm). The basis of sample size calculation is based on an assumption that mean change in PRAM at 60 minutes is -3.5 in ketamine arm vs -2 points in placebo hence between-group difference of 1.5 points favoring ketamine with assumed SD 2. Given that the expected number of patients with \>=3 points drop in PRAM in ketamine group is 33 and in placebo 17 with a study power 80% at level of error 5%. Minimum sample size required is 46 (23 in each arm)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zahraa Al Lawati, Sultan Qaboos University
- Investigators
- Zahraa Ali Al Lawati, Principal investigator, College of Medicine and Health Sciences , Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728851
- Sponsor's protocol ID
- SQU-EC/ 207\2025 MREC#3805
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) for all primary and secondary outcome measures will be made available to qualified researchers upon reasonable request.
Publications
Nguyen T, Mai M, Choudhary A, Gitelman S, Drapkin J, Likourezos A, Kabariti S, Hossain R, Kun K, Gohel A, Niceforo P, Silver M, Motov S. Comparison of Nebulized Ketamine to Intravenous Subdissociative Dose Ketamine for Treating Acute Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind, Double-Dummy Controlled Trial. Ann Emerg Med. 2024 Oct;84(4):354-362. doi: 10.1016/j.annemergmed.2024.03.024. Epub 2024 May 2.
PubMed 38703175Elkoundi A, Bentalha A, El Koraichi A, El Kettani SE. Nebulized ketamine to avoid mechanical ventilation in a pediatric patient with severe asthma exacerbation. Am J Emerg Med. 2018 Apr;36(4):734.e3-734.e4. doi: 10.1016/j.ajem.2018.01.027. Epub 2018 Jan 6.
PubMed 29321114Farshadfar K, Sohooli M, Shekouhi R, Taherinya A, Qorbani M, Rezaei-Kojani M. The effects of nebulized ketamine and intravenous magnesium sulfate on corticosteroid resistant asthma exacerbation; a randomized clinical trial. Asthma Res Pract. 2021 Nov 30;7(1):15. doi: 10.1186/s40733-021-00081-1.
PubMed 34847965Binsaeedu AS, Prabakar D, Ashkar M, Joseph C, Alsabri M. Evaluating the Safety and Efficacy of Ketamine as a Bronchodilator in Pediatric Patients With Acute Asthma Exacerbation: A Review. Cureus. 2023 Jun 22;15(6):e40789. doi: 10.7759/cureus.40789. eCollection 2023 Jun.
PubMed 37485092Trottier ED, Chan K, Allain D, Chauvin-Kimoff L. Managing an acute asthma exacerbation in children. Paediatr Child Health. 2021 Nov 11;26(7):438-439. doi: 10.1093/pch/pxab058. eCollection 2021 Nov.
PubMed 34777663Al-Riyami BMS, Al-Rawas OAS, Al-Riyami AA, Jasim LG, Mohammed AJ. Prevalence of asthma symptoms in Omani schoolchildren. J Sci Res Med Sci. 2001 Apr;3(1):21-27.
PubMed 28811724