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

ConditionsAsthma AcuteAsthma AttackAsthma 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Drug

    \*\*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.

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

    Drug

    \*\*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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Nebulized ketamine (0.5 mg/kg) + standard care for moderate to severe asthma exacerbationExperimental treatment 1 intervention
Group B: Placebo nebulization (normal saline) + standard care for moderate to severe asthma exacerbationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Change in PEFR at 30 minutes

Time frame
30 minutes
2

• Incidence of adverse effects

Time frame
60 minutes
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Medical Speciality Board

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: