Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Phase 4

Terminated

• Conditions: Anxiety; Pediatric ALL; Procedural Anxiety
• Interventions: Drug: Midazolam 5 MG/ML; Drug: Ketamine 100 MG/ML

• Registration Number: NCT03043430
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Status Verified: 2023-04
• Primary Completion: 2023-04
• Study Completion: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Midazolam 5 MG/ML	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.
Ketamine	Ketamine 100 MG/ML	Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device.

Primary Outcome Measures

Name	Time	Method
Change in mYPAS	Change in score between initial measurement versus 5 minutes pre-procedure	Modified Yale preoperative anxiety scale

Secondary Outcome Measures

Name	Time	Method
Change in pain rating (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	Wong-Baker Pain Faces Rating Scale
Change in anxiety score (Visual analogue scale)	Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge	Visual analogue scale
Change in sedation scale	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

Trial Locations

Locations (1)

San Antonio Military Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States