Nebulized Ketamine for Severe Asthma Attacks in Children

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in Pediatric Respiratory Assessment Measure (PRAM) score. [Срок оценки: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)]

Вторичные конечные точки (5)

• Proportion of participants requiring non-invasive ventilation (NIV) or mechanical ventilation [Срок оценки: Up to 24 hours after first dose]
• Length of stay in the HDU/PICU [Срок оценки: Through study completion, an average of 5 days]
• Change in heart rate [Срок оценки: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours]
• Change in respiratory rate [Срок оценки: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours]
• Change in oxygen saturation [Срок оценки: Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Oman · 1 центр

• Sultan Qaboos University Hospital — Muscat

Публикации

• 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 PMID 38703175
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07728851 · SQU-EC/ 207\2025 MREC#3805

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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