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

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ClinicalTrials.gov Identifier: NCT03338205
Recruitment Status : Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Augusta University

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date July 16, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Efficacy of ketamine in status asthmaticus by assessing change in clinical asthma score (CAS) [ Time Frame: prior to intervention, 30 minutes and 60 minutes after administration of ketamine ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus
Official Title  ICMJE The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Status Asthmaticus
Intervention  ICMJE Drug: Ketamine
1 mg/kg ketamine bolus IV
Study Arms  ICMJE Experimental: Ketamine Treatment

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
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aimee E Baer Ellington, MD 770-354-2112 abaerellington@augusta.edu
Contact: Lorna Bell, MD 7065332910 lbell@augusta.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03338205
Other Study ID Numbers  ICMJE 51152
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Augusta University
Study Sponsor  ICMJE Augusta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Augusta University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP