Clinical trial NCT03338205: The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus
Official title: The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Status Asthmaticus
Keywords: ketamine
pediatric status asthmaticus
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

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 in acute status asthmaticus who have failed standard emergency therapy.

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 emergency department 24 hours a day. The attending physician who is clinically treating the patient will identify the patient as a potential study candidate (see inclusion criteria). Study team members will then be notified and obtain informed consent for potential participants who meet the inclusion/exclusion criteria.

Once a patient in the Augusta University Children's Hospital of Georgia Pediatric Emergency Department is deemed a potential study subject, informed consent will be obtained by the research study team members. The patient and their parents will be provided with all the required information about the study including potential risks and benefits associated with participation. The information will be presented in a private setting in a language the patient understands. The patient and/or their parent/guardian will have opportunities to ask questions and will be given enough time to consider participation before providing consent. A document will be given to obtain assent/consent that reiterates all the information about the study (including reason for the study, risks, benefits, etc.)

Study team members that will be actively involved in the study will be either pediatric emergency medicine faculty or pediatric emergency medicine fellows that are on staff.

Patients that meet the inclusion and exclusion criteria will have ketamine 1 mg/kg IV bolus administered once informed consent has been obtained.

Eligibility 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)

Primary outcomes:
measure: Efficacy of ketamine in status asthmaticus by assessing change in clinical asthma score (CAS)
timeFrame: prior to intervention, 30 minutes and 60 minutes after administration of ketamine
Secondary outcomes:
Other outcomes:
Locations:
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