Nebulized ketamine added to standard care for moderate to severe asthma attacks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial will compare nebulized ketamine plus standard asthma care to placebo nebulization plus standard care in adults presenting to the emergency department with moderate to severe exacerbations. Participants will receive the assigned nebulized treatment and standard asthma therapy, with breathing measured by peak flow before and after treatment and ongoing monitoring for 60 minutes to assess symptoms, vital signs, and any side effects. The aim is to determine if inhaled ketamine improves lung function and is safe in this setting. The study uses a randomized, placebo-controlled design to evaluate both efficacy and safety in an acute care environment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 years or older presenting to the Emergency Department with a clinical diagnosis of moderate to severe asthma exacerbation based on SIGN (Scottish Intercollegiate Guidelines Network) criteria.
2. PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter.
3. Stable vital signs as deemed by the treating physician
4. Alert and oriented, able to understand the study purpose and provide informed consent.
5. Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation.

Exclusion Criteria:

1. Known hypersensitivity or allergy to ketamine or any component of the nebulized solution.
2. History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders.
3. Uncontrolled hypertension, defined as systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg on two consecutive readings at least 5 minutes apart, despite initial ED management.
4. Hemodynamic instability, including persistent hypotension (SBP \< 90 mmHg) or tachyarrhythmias requiring urgent treatment.
5. Significant chronic lung disease, including:

   * COPD with frequent exacerbations or baseline FEV₁ \< 50% predicted
   * Interstitial lung disease (ILD)
   * Clinically significant bronchiectasis with baseline productive cough or infection
6. Pregnancy or currently breastfeeding.
7. Home BiPAP use or requirement for non-invasive ventilation (e.g., BiPAP/CPAP) during the ED visit (Note: isolated home CPAP for sleep apnea without daytime symptoms is acceptable).
8. Current intubation or imminent need for mechanical ventilation based on clinical judgment.
9. Severe cardiac disease, including decompensated heart failure, recent myocardial infarction (\<6 weeks), or known severe valvular disease.
10. Any other medical, surgical, or psychiatric condition that in the opinion of the investigator would place the patient at undue risk from study participation or interfere with the interpretation of study results.

Where it's running

• Sultan Qaboos University Hospital
  Muscat, Alkhoudh, Oman Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.