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

NCT03338205 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 51152
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Status Asthmaticus

Keywords

ketamine; pediatric status asthmaticus

Outcome Measures

Primary Outcomes (1)

• Efficacy of ketamine in status asthmaticus by assessing change in clinical asthma score (CAS)

  CAS will be documented on admission, prior to intervention, 30 minutes and 60 minutes after administration of ketamine. The CAS is a scoring system to assess the severity of asthma used by Augusta University and is based on physiological measurements and clinical appearance.

  prior to intervention, 30 minutes and 60 minutes after administration of ketamine

Study Arms (1)

Ketamine Treatment

EXPERIMENTAL

Everyone enrolled in study presenting in status asthmaticus to pediatric emergency department at Augusta University will receive a ketamine treatment, who include: * Patients with a Clinical Asthma SCore (CAS) of greater than or equal to 10 on presentation and 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 receiving 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 when as measured 1 hour after initiation of standard treatment per Augusta University's moderate asthma pathway

Drug: Ketamine

Interventions

Ketamine DRUG

1 mg/kg ketamine bolus IV

Ketamine Treatment

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Augusta University: lead

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 9, 2017
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02