Overview

Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Status:
Suspended
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brooke Army Medical Center
Treatments:
Ketamine
Midazolam
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