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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

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).

Condition or disease Intervention/treatment Phase
Anxiety Pediatric ALL Procedural Anxiety Drug: Ketamine 100 MG/ML Drug: Midazolam 5 MG/ML Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
Actual Study Start Date : May 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
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.
Drug: Ketamine 100 MG/ML
Administer ketamine via mucosal atomization device

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.
Drug: Midazolam 5 MG/ML
Administer midazolam via mucosal atomization device




Primary Outcome Measures :
  1. Change in mYPAS [ Time Frame: Change in score between initial measurement versus 5 minutes pre-procedure ]
    Modified Yale preoperative anxiety scale


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03043430


Locations
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United States, Texas
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Nadia M Pearson, MD Faculty Physician

Publications:
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Responsible Party: Michael D. April, Assistant Program Director for Research, EM Residency, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03043430     History of Changes
Other Study ID Numbers: C.2016.021
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Emergencies
Anxiety Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents