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

Not Applicable

Not yet recruiting

• Conditions: Asthma Acute; Asthma Exacerbations; Asthma Attack
• Interventions: Drug: Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare; Drug: Placebo nebulization (5 mL normal saline) plus standard asthma care

• Registration Number: NCT07112456
• Lead Sponsor: Oman Medical Speciality Board

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2026-09-01
• Primary Completion: 2029-08-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized ketamine (0.5 mg/kg) + standard care for moderate to severe asthma exacerbation	Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare	Participants in the intervention arm will receive a single dose of nebulized ketamine at 0.5 mg/kg, diluted in normal saline to a total volume of 5ml, administered via a standard jet nebulizer. This will be given after standard asthma care, which includes salbutamol, ipratropium bromide, systemic corticosteroids (e.g., oral prednisolone or IV hydrocortisone), and supplemental oxygen as needed. The goal is to assess whether adding nebulized ketamine improves respiratory function, measured by peak expiratory flow rate (PEFR), compared to standard care alone. Participants will be monitored for 60 minutes after treatment for changes in PEFR, symptom relief, and any adverse effects. The intervention is non-invasive and administered in the emergency department for adult patients with moderate to severe asthma exacerbations.
Placebo nebulization (normal saline) + standard care for moderate to severe asthma exacerbation	Placebo nebulization (5 mL normal saline) plus standard asthma care	Participants in the control arm will receive a placebo nebulization consisting of 5 mL of normal saline, administered via a standard jet nebulizer. This will be given in addition to standard asthma care, which includes salbutamol, ipratropium bromide, systemic corticosteroids (e.g., oral prednisolone or IV hydrocortisone), and supplemental oxygen as needed. The placebo is indistinguishable in appearance and administration method from the active treatment to maintain blinding. This arm is designed to evaluate the effects of standard care alone on peak expiratory flow rate (PEFR), symptom relief, and adverse events, and will be compared to the intervention group receiving nebulized ketamine. All participants will be monitored for 60 minutes following treatment in the emergency department setting.

Primary Outcome Measures

Name	Time	Method
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention	Baseline (0 minutes) and 60 minutes post-intervention	PEFR will be measured using a peak flow meter at baseline (0 minutes) and at 60 minutes after administration of the intervention. The change in PEFR will be calculated to assess the intervention effect.

Secondary Outcome Measures

Name	Time	Method
• Incidence of adverse effects	60 minutes
Change in PEFR at 30 minutes	30 minutes
Incidence of intravenous magnesium sulfate administration	60 minutes	The proportion of participants who receive intravenous magnesium sulfate as part of escalation of care after 60 minutes post-intervention.
Incidence of ICU admission	60 minutes	The proportion of participants who require transfer to an intensive care unit (ICU) after 60 minutes post-intervention.
Incidence of endotracheal intubation	60 minutes	The proportion of participants who undergo endotracheal intubation after 60 minutes post-intervention due to clinical deterioration.
Incidence of non-invasive ventilation (BiPAP) initiation	60 minutes	The proportion of participants who require initiation of bilevel positive airway pressure (BiPAP) after 60 minutes post-intervention as part of escalation of care.
Disposition plan (discharged, admitted, or transferred)	60 minutes
Length of stay (if admitted)	60 minutes
Type of admission bed (e.g., ward vs. ICU)	60 minutes
Change in dyspnea severity as measured by the Visual Analogue Scale (VAS)	60 minutes	Patient-reported breathlessness will be assessed using the Visual Analogue Scale (VAS), a 10-centimeter horizontal line ranging from 0 to 10. A score of 0 represents "no breathlessness," and a score of 10 represents "worst imaginable breathlessness." The change in VAS score from baseline to 60 minutes post-intervention will be recorded.