The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03338205|
Recruitment Status : Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Status Asthmaticus||Drug: Ketamine||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot study|
|Masking:||None (Open Label)|
|Official Title:||The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||January 2022|
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:
1 mg/kg ketamine bolus IV
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338205
|Contact: Aimee E Baer Ellington, MDfirstname.lastname@example.org|
|Contact: Lorna Bell, MDemail@example.com|