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