Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOman Medical Speciality Board
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare
- Placebo nebulization (5 mL normal saline) plus standard asthma care
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov