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NCT07112456

PHASE2

Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations

Sponsor: Oman Medical Speciality Board

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if nebulized ketamine helps treat moderate to severe asthma attacks in adults in the emergency department. It will also learn about the safety of ketamine when inhaled through a nebulizer. The main questions it aims to answer are: * Does nebulized ketamine improve breathing more than standard treatment alone? * What side effects, if any, do participants experience after receiving nebulized ketamine? Researchers will compare nebulized ketamine to a placebo (a saltwater mist with no medication) to see how well it works and how safe it is. Participants will: * Receive either nebulized ketamine or a placebo mist, along with standard asthma treatment * Have their breathing checked before and after treatment using a peak flow meter * Be monitored for 60 minutes and have their symptoms, vital signs, and any side effects recorded

Official title: Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations: A Randomized Clinical Trial (KET-AIR Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09-01

Completion Date

2029-08-31

Last Updated

2025-08-08

Healthy Volunteers

Conditions

Asthma Acute Asthma Attack Asthma Exacerbations

Interventions

DRUG

Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare

\*\*Intervention Description:\*\* Nebulized ketamine is administered as a single dose of 0.5 mg/kg of ketamine hydrochloride diluted in 0.9% normal saline to a total volume of 5ml. The solution is delivered via a standard jet nebulizer over approximately 15-20minutes. This intervention is given once at the time of enrollment in the emergency department, in addition to standard asthma care. The ketamine used is in injectable solution form (typically 50 mg/mL concentration), drawn and diluted immediately prior to nebulization. Participants are monitored continuously for 60 minutes after administration to assess changes in peak expiratory flow rate (PEFR), symptom relief, and adverse events. The goal is to evaluate the bronchodilatory effect and safety of nebulized ketamine in adults with moderate to severe asthma exacerbation who present to the emergency department.

DRUG

Placebo nebulization (5 mL normal saline) plus standard asthma care

\*\*Intervention Description (Control Group):\*\* Participants in the control group will receive a single nebulized dose of 5 mL of 0.9% normal saline, delivered using a standard jet nebulizer over approximately 10-15 minutes. This placebo intervention is administered once at the time of enrollment in the emergency department, after standard asthma care. Standard care includes repeated doses of nebulized salbutamol and ipratropium, systemic corticosteroids (oral or intravenous), and supplemental oxygen as needed. The placebo solution is identical in appearance and volume to the active ketamine solution used in the intervention group to maintain blinding. All participants will be monitored for 60 minutes after nebulization to assess changes in peak expiratory flow rate (PEFR), symptom relief using a visual analog scale (VAS), and the occurrence of any adverse events.

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.

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Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations

Summary

Key Details

Conditions

Interventions

Eligibility Criteria