Nebulized Ketamine for Severe Asthma Attacks in Children

NCT07728851 | Not Yet Recruiting Phase 2

• 1 other identifier: SQU-EC/ 207\2025 MREC#3805
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Asthma; Ketamine

Outcome Measures

Primary Outcomes (1)

• Change in Pediatric Respiratory Assessment Measure (PRAM) score.

  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 Outcomes (5)

• Proportion of participants requiring non-invasive ventilation (NIV) or mechanical ventilation

  Up to 24 hours after first dose

• Length of stay in the HDU/PICU

  Through study completion, an average of 5 days

• Change in heart rate

  Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

• Change in respiratory rate

  Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

• Change in oxygen saturation

  Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours

Study Arms (2)

Group A (Ketamine)

ACTIVE COMPARATOR

Nebulised ketamine 1 mg/kg per dose every 6 hours for 24 hours (4 doses total).

Drug: Ketamine (1 mg/kg)

Group B (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Group A (Ketamine)

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.

Group B (Placebo)

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, Oman

Location

Related Publications (6)

• Nguyen T, Mai M, Choudhary A, Gitelman S, Drapkin J, Likourezos A, Kabariti S, Hossain R, Kun K, Gohel A, Niceforo P, Silver M, Motov S. Comparison of Nebulized Ketamine to Intravenous Subdissociative Dose Ketamine for Treating Acute Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind, Double-Dummy Controlled Trial. Ann Emerg Med. 2024 Oct;84(4):354-362. doi: 10.1016/j.annemergmed.2024.03.024. Epub 2024 May 2.

  PMID: 38703175 BACKGROUND

• Elkoundi A, Bentalha A, El Koraichi A, El Kettani SE. Nebulized ketamine to avoid mechanical ventilation in a pediatric patient with severe asthma exacerbation. Am J Emerg Med. 2018 Apr;36(4):734.e3-734.e4. doi: 10.1016/j.ajem.2018.01.027. Epub 2018 Jan 6.

  PMID: 29321114 BACKGROUND

• Farshadfar K, Sohooli M, Shekouhi R, Taherinya A, Qorbani M, Rezaei-Kojani M. The effects of nebulized ketamine and intravenous magnesium sulfate on corticosteroid resistant asthma exacerbation; a randomized clinical trial. Asthma Res Pract. 2021 Nov 30;7(1):15. doi: 10.1186/s40733-021-00081-1.

  PMID: 34847965 BACKGROUND

• Binsaeedu AS, Prabakar D, Ashkar M, Joseph C, Alsabri M. Evaluating the Safety and Efficacy of Ketamine as a Bronchodilator in Pediatric Patients With Acute Asthma Exacerbation: A Review. Cureus. 2023 Jun 22;15(6):e40789. doi: 10.7759/cureus.40789. eCollection 2023 Jun.

  PMID: 37485092 BACKGROUND

• Trottier ED, Chan K, Allain D, Chauvin-Kimoff L. Managing an acute asthma exacerbation in children. Paediatr Child Health. 2021 Nov 11;26(7):438-439. doi: 10.1093/pch/pxab058. eCollection 2021 Nov.

  PMID: 34777663 BACKGROUND

• Al-Riyami BMS, Al-Rawas OAS, Al-Riyami AA, Jasim LG, Mohammed AJ. Prevalence of asthma symptoms in Omani schoolchildren. J Sci Res Med Sci. 2001 Apr;3(1):21-27.

  PMID: 28811724 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Zahraa Ali Al Lawati

  College of Medicine and Health Sciences , Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Ali Al Lawati

CONTACT

+96892347374; zlawati@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: An independent statistician will generate a computer-based allocation list with variable permuted blocks, stratified by age group (1-5 vs 6-13 years). The hospital pharmacy will prepare 60 sequentially numbered, identical medication packs (001-060) containing either ketamine or 0.9% saline according to this concealed list. Packs will be visually indistinguishable (same volume and appearance); only the pack number will appear on the label. At enrolment, the bedside team will request the next available pack in sequence. Investigators, treating clinicians, parents/guardians, outcome assessors, and statisticians will remain blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a phase-2 pilot designed to estimate effect size/variance, characterise safety, and assess feasibility. A total of 60 participants (30 per arm) will provide adequate precision around the mean difference in PRAM change and around AE rates to inform a future definitive phase-3 trial. Sample size of 60 (30 in each arm). The basis of sample size calculation is based on an assumption that mean change in PRAM at 60 minutes is -3.5 in ketamine arm vs -2 points in placebo hence between-group difference of 1.5 points favoring ketamine with assumed SD 2. Given that the expected number of patients with \>=3 points drop in PRAM in ketamine group is 33 and in placebo 17 with a study power 80% at level of error 5%. Minimum sample size required is 46 (23 in each arm)

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 5 years following publication of the main results.
• 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.

Locations

OM (1)