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

Official title

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

Overview

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

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 imme
• 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

Primary outcome measures

• Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention [Time frame: Baseline (0 minutes) and 60 minutes post-intervention]

Secondary outcome measures (10)

• Change in PEFR at 30 minutes [Time frame: 30 minutes]
• • Incidence of adverse effects [Time frame: 60 minutes]
• Incidence of intravenous magnesium sulfate administration [Time frame: 60 minutes]
• Incidence of ICU admission [Time frame: 60 minutes]
• Incidence of endotracheal intubation [Time frame: 60 minutes]
• Incidence of non-invasive ventilation (BiPAP) initiation [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) [Time frame: 60 minutes]

Eligibility criteria

Inclusion criteria

• 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.
• PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter.
• Stable vital signs as deemed by the treating physician
• Alert and oriented, able to understand the study purpose and provide informed consent.
• Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation.

Exclusion criteria

• Known hypersensitivity or allergy to ketamine or any component of the nebulized solution.
• History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders.
• 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.
• Hemodynamic instability, including persistent hypotension (SBP < 90 mmHg) or tachyarrhythmias requiring urgent treatment.
• 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
• Pregnancy or currently breastfeeding.
• 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).
• Current intubation or imminent need for mechanical ventilation based on clinical judgment.
• Severe cardiac disease, including decompensated heart failure, recent myocardial infarction (<6 weeks), or known severe valvular disease.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07112456 · OMSB24030

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗