Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Ketamine

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).

Intervention / Treatment

Subjects will be randomized to one of two treatment arms.
  • Ketamine 100 MG/ML (DRUG)
    Administer ketamine via mucosal atomization device
  • Midazolam 5 MG/ML (DRUG)
    Administer midazolam via mucosal atomization device

Condition or Disease

  • Anxiety
  • Pediatric ALL
  • Procedural Anxiety

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 2 Years to 12 Years
    Enrollment: 10 (ACTUAL)
    Funded by: U.S. Fed
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    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.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 01, 2016 ACTUAL
    Primary Completion: Apr 01, 2023 ACTUAL
    Completion Date: Apr 01, 2023 ACTUAL
    Study First Posted: Feb 06, 2017 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 23, 2023

    Sponsors / Collaborators

    Lead Sponsor: Brooke Army Medical Center
    Responsible Party: N/A

    Location

    Fort Sam Houston, Texas, USA

    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.

    Participant Groups

    • Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Modified Yale preoperative anxiety scale

    Secondary Outcomes

    • University of Michigan sedation scale

    • Wong-Baker Pain Faces Rating Scale

    • Visual analogue scale

    More Details

    NCT Number: NCT03043430
    Other IDs: C.2016.021
    Study URL: https://clinicaltrials.gov/study/NCT03043430
    Last updated: Sep 29, 2023