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NCT Number: NCT07728851

Nebulized Ketamine for Severe Asthma Attacks in Children

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.

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Key information

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine (1 mg/kg)

Drug

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

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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 (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Zahra Ali Al Lawati

CONTACT

[email protected]

+96892347374

Sponsors and collaborators

Lead sponsor

Sultan Qaboos University

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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