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Nebulized Ketamine for Severe Asthma Attacks in Children

NCT07728851 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-27

No results posted yet for this study

Summary

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.

Conditions

  • Asthma Acute
  • Exacerbation of Allergic Asthma

Interventions

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.

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.

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Principal Investigators

  • Zahraa Ali Al Lawati · College of Medicine and Health Sciences , Sultan Qaboos University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Oman

Study Locations

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Entities

Drugs

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 NCT07728851 on ClinicalTrials.gov