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Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT03043430
Recruitment Status : Suspended (Research manpower shortage)
First Posted : February 6, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Michael D. April, Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 6, 2017
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
Change in mYPAS [ Time Frame: Change in score between initial measurement versus 5 minutes pre-procedure ]
Modified Yale preoperative anxiety scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • Change in sedation scale [ Time Frame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge ]
    University of Michigan sedation scale
  • Change in pain rating (Wong-Baker Pain Faces Rating Scale) [ Time Frame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge ]
    Wong-Baker Pain Faces Rating Scale
  • Change in anxiety score (Visual analogue scale) [ Time Frame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge ]
    Visual analogue scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients
Official Title  ICMJE Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
Brief Summary Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).
Detailed Description The intranasal route of drug delivery is commonly used in Emergency Departments (ED) in pediatric patients. Multiple trials have shown the safety of administration of intranasal ketamine, including studies performed in the ED to treat pain in pediatric patients. The use of ketamine for anxiolysis has not been directly studied; however, ketamine has been shown to have anxiolytic effect at low doses as secondary outcomes when studied. Midazolam has been established as an effective medication to provide analgesia and anxiolysis. Investigators plan to conduct a randomized, double-blinded, controlled study in the Emergency Department. Pediatric patients presenting to the ED with the need for minor procedures who meet the inclusion and exclusion criteria will be consented, and if amenable, will be enrolled. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). Patients will be tracked for symptom improvement within the Emergency Department. The primary outcome will be change in anxiety from initial measurement to measurement 5 minutes pre-procedure using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes will include sedation level, adverse events, need for additional medications, change in pain rating, patient and/or parent/guardian satisfaction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized to one of two treatment arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Medication (ketamine versus midazolam) will be drawn up in unmarked syringe and applied to the patient by mucosal atomization device by a nurse not directly involved in the investigation or the patient's care.
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety
  • Pediatric ALL
  • Procedural Anxiety
Intervention  ICMJE
  • Drug: Ketamine 100 MG/ML
    Administer ketamine via mucosal atomization device
  • Drug: Midazolam 5 MG/ML
    Administer midazolam via mucosal atomization device
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device.
    Intervention: Drug: Ketamine 100 MG/ML
  • Active Comparator: Midazolam
    Midazolam 5 mg/mL concentration administered in a single administered in a single 0.3 mg/kg dose with a maximum of 5mg intranasal via mucosal atomization device.
    Intervention: Drug: Midazolam 5 MG/ML
Publications *

*   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 Suspended
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients age 2 to 12 years who present to the ED
  • Requiring intravenous access
  • Requiring laceration repairs
  • Requiring incision and drainage of abscesses
  • Requiring digital nerve blocks
  • Requiring radiological imaging
  • Requiring bladder catheterization
  • Requiring foreign body removal.

Exclusion Criteria:

  • Vital sign abnormalities greater than 20% deviation from age-normalized ranges
  • Altered mental status/delirium or intoxication
  • Patient or patient's parent/guardian are unwilling to participate or provide informed consent
  • Any allergy to ketamine or midazolam
  • Patient is female with history of menarche
  • Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
  • Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
  • Presence of intracranial mass or vascular lesion.
  • Presence of a history of psychosis or hallucinations
  • Weight greater than 100kg
  • History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
  • Non-English speaking/reading parent/guardian and/or patients
  • Patient is acutely psychotic
  • Provider feels that patient currently or likely will require chemical and/or physical restraints
  • History of prolonged QT-interval
  • Nasal trauma
  • Epistaxis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03043430
Other Study ID Numbers  ICMJE C.2016.021
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael D. April, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadia M Pearson, MD Faculty Physician
PRS Account Brooke Army Medical Center
Verification Date July 2019

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