The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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 in acute status asthmaticus who have failed standard emergency therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)