Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial

Conditions
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Anxiety, Pediatric ALL, Procedural Anxiety

Intervention / Treatment
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* Drug: Ketamine 100 MG/ML
* Drug: Midazolam 5 MG/ML


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to one of two treatment arms.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>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<br>* Administer ketamine via mucosal atomization device<br>|
| Active Comparator: Midazolam<br>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<br>* Administer midazolam via mucosal atomization device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mYPAS | Modified Yale preoperative anxiety scale | Change in score between initial measurement versus 5 minutes pre-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedation scale | University of Michigan sedation scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | 
| Change in pain rating (Wong-Baker Pain Faces Rating Scale) | Wong-Baker Pain Faces Rating Scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | 
| Change in anxiety score (Visual analogue scale) | Visual analogue scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge |