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

NCT07112456 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-08

No results posted yet for this study

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

Conditions

  • Asthma Acute
  • Asthma Attack
  • Asthma Exacerbations

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 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.

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 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.

Sponsors & Collaborators

  • Oman Medical Speciality Board

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-08-31
Completion
2029-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07112456 on ClinicalTrials.gov