Nebulized Ketamine for Severe Asthma Attacks in Children

July 23, 2026 updated by: Dr. Zahraa Al Lawati, Sultan Qaboos University

Effectiveness and Safety of Nebulized Ketamine in Severe Pediatric Asthma: a Phase-2, Double-blind, Randomized, Placebo-controlled Pilot Trial

This is a double-blinded, randomised, placebo-controlled trial enrolling 60 children aged 1 to 13 years with severe asthma exacerbation. All participants will receive standard therapy. Children not responding to standard therapy will be randomised to intervention arms. Randomization will occur in a 1:1 ratio using a computer-generated Excel sequence with permuted blocks of four, stratified by age (1-5 and 6-13 years). Patients will receive either nebulized ketamine (1 mg/kg every 6 hours for 24 hours) or 0.9% normal saline placebo. Randomization codes will be maintained by the hospital pharmacy, which will prepare identical numbered packs. During working hours, the pharmacist will dispense the allocated medication; at nights and weekends, pre-prepared packs will be stored securely in the PHDU/PICU under the supervision of the nursing in-charge. Blinding will be maintained for patients, clinicians, and outcome assessors. PRAM scores will be recorded at baseline and at 20, 60, 90, and 120 minutes post-dose. The primary outcome is pediatric respiratory assessment measure (PRAM) score change. Secondary outcomes include need for NIV or intubation and HDU/PICU length of stay.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Oman
      • Muscat, Oman
        • Sultan Qaboos University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zahraa Al Lawati
        • Sub-Investigator:
          • Raghad Al Abdwani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 1 to 13 years.
  • Diagnosis of severe asthma exacerbation (PRAM score 8-12)
  • Prior treatment with standard first-line management (beta-2 agonist, corticosteroid, magnesium sulfate)

Exclusion Criteria:

  • Known allergy or adverse reaction to ketamine
  • Significant hemodynamic instability
  • Systemic hypertension >95th percentile for age
  • Cardiac arrhythmias
  • Congestive heart failure
  • Obstructive sleep apnea with AHI >5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Ketamine)
Nebulised ketamine 1 mg/kg per dose every 6 hours for 24 hours (4 doses total).
Drug: Ketamine (1 mg/kg)

Group A (Ketamine)

  • Nebulised ketamine 1 mg/kg per dose every 6 hours for 24 hours (4 doses total).
  • Ketamine solution (e.g. 10 mg/mL) diluted with 0.9% saline to a total volume of 3-5 mL.

Nebulisation will be delivered via jet nebuliser with oxygen flow 6-8 L/min using a mask. A dose will be considered complete when the nebuliser chamber is dry.
Placebo Comparator: Group B (Placebo)
Nebulised 0.9% saline, 3-5 mL per dose, every 6 hours for 24 hours.
Drug: Placebo

Nebulised 0.9% saline, 3-5 mL per dose, every 6 hours for 24 hours.

Nebulisation will be delivered via jet nebuliser with oxygen flow 6-8 L/min using a mask. A dose will be considered complete when the nebuliser chamber is dry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Respiratory Assessment Measure (PRAM) score.
Time Frame: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)
Mean difference in the change in Pediatric Respiratory Assessment Measure (PRAM) score within 60 minutes of treatment between the nebulized ketamine and placebo groups. The PRAM is a validated clinical asthma severity score ranging from 0 to 12, where higher scores indicate more severe respiratory distress (a worse outcome) and a greater reduction indicates clinical improvement.
Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants requiring non-invasive ventilation (NIV) or mechanical ventilation
Time Frame: Up to 24 hours after first dose
Number and percentage of participants who require escalation to non-invasive ventilation (NIV) or invasive mechanical ventilation during the treatment period.
Up to 24 hours after first dose
Length of stay in the HDU/PICU
Time Frame: Through study completion, an average of 5 days
Duration of stay in the High Dependency Unit (HDU) or Pediatric Intensive Care Unit (PICU), measured in days.
Through study completion, an average of 5 days
Change in heart rate
Time Frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

Change in heart rate (beats per minute) from baseline, monitored to assess therapeutic response and possible hemodynamic effects of the study medication.

Unit: beats per minute
Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
Change in respiratory rate
Time Frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

Change in respiratory rate (breaths per minute) from baseline as a marker of clinical improvement.

Unit: breaths per minute
Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours
Change in oxygen saturation
Time Frame: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

Change in peripheral oxygen saturation (SpO2, %) from baseline as a marker of clinical improvement.

Unit: percentage (%)
Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Qaboos University

Investigators

  • Principal Investigator: Zahraa Ali Al Lawati, College of Medicine and Health Sciences , Sultan Qaboos University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQU-EC/ 207\2025 MREC#3805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) for all primary and secondary outcome measures will be made available to qualified researchers upon reasonable request.

IPD Sharing Time Frame

Data will be available beginning 6 months and ending 5 years following publication of the main results.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to Zlawati@squ.edu.om. Requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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