Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Brooke Army Medical Center

Status and phase: Terminated; Phase 4

Conditions: Pediatric ALL; Procedural Anxiety; Anxiety

Treatments: Drug: Ketamine 100 MG/ML; Drug: Midazolam 5 MG/ML

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03043430

C.2016.021

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Ketamine

Experimental group

Description:

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

Treatment:

Drug: Ketamine 100 MG/ML

Midazolam

Active Comparator group

Description:

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.

Treatment:

Drug: Midazolam 5 MG/ML