A Phase 2 interventional study of Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare and Placebo nebulization (5 mL normal saline) plus standard asthma care in Asthma Acute, Asthma Attack and Asthma Exacerbations, sponsored by Oman Medical Speciality Board. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Oman Medical Speciality Board · Phase 2, Interventional, and Treatment
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:
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:
Exclusion Criteria:
Significant chronic lung disease, including:
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.
Drug: Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare
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.
Drug: Placebo nebulization (5 mL normal saline) plus standard asthma care
\*\*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.
\*\*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.
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 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.
Time frame: Baseline (0 minutes) and 60 minutes post-intervention
Change in PEFR at 30 minutes
Time frame: 30 minutes
• Incidence of adverse effects
Time frame: 60 minutes
Incidence of intravenous magnesium sulfate administration
The proportion of participants who receive intravenous magnesium sulfate as part of escalation of care after 60 minutes post-intervention.
Time frame: 60 minutes
Incidence of ICU admission
The proportion of participants who require transfer to an intensive care unit (ICU) after 60 minutes post-intervention.
Time frame: 60 minutes
Incidence of endotracheal intubation
The proportion of participants who undergo endotracheal intubation after 60 minutes post-intervention due to clinical deterioration.
Time frame: 60 minutes
Incidence of non-invasive ventilation (BiPAP) initiation
The proportion of participants who require initiation of bilevel positive airway pressure (BiPAP) after 60 minutes post-intervention as part of escalation of care.
Time frame: 60 minutes
Disposition plan (discharged, admitted, or transferred)
Time frame: 60 minutes
Length of stay (if admitted)
Time frame: 60 minutes
Type of admission bed (e.g., ward vs. ICU)
Time frame: 60 minutes
Change in dyspnea severity as measured by the Visual Analogue Scale (VAS)
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.
Time frame: 60 minutes
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Oman Medical Speciality Board