Status:
WITHDRAWN
The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus
Lead Sponsor:
Augusta University
Conditions:
Status Asthmaticus
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
The purpose of this investigation is to perform a pilot study assessing the safety and utility of intravenous ketamine as an adjuvant therapy in the emergency department setting for pediatric patients...
Detailed Description
This is a pilot study of a cohort of 20 subjects to assess the feasibility, safety and efficacy of ketamine in status asthmaticus. The study will take place at the Augusta University's pediatric emer...
Eligibility Criteria
Inclusion
- Pediatric patients (≥2 years and ≤ 18 years old)
- Patients presenting in status asthmaticus:
- Patients with a CAS of greater than or equal to 10 on presentation that have received at least two (appropriately dosed based on weight) albuterol treatments prior to arrival
- OR
- Patients with a CAS of greater than or equal to 10 that have not received treatment prior to arrival and after 1 hour of treatment per the severe asthma pathway do not have a decrease in CAS of greater than 2
- OR
- Patients with a CAS above 6 but less than 10 as measured 1 hour after initiation of standard treatment per AU's moderate asthma pathway
Exclusion
- Pregnancy
- Congestive Heart Failure or prior diagnosis of cardiovascular disease (congenital or acquired)
- Chronic lung disease outside of a previous diagnosis of Asthma
- Seizure disorder
- Liver disease
- History of hypertension greater than 95% for age
- Obstructive Sleep Apnea with AHI greater than 5
- History of allergic or serious reaction to Ketamine
- Significant history of psychiatric illness defined as any patient with a diagnosis of psychiatric illness meeting the Diagnostic and Statistical Manual of Mental Disorders V criteria (severe Autism)
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03338205
Start Date
January 1 2020
End Date
January 1 2022
Last Update
February 6 2024
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