Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Stopped early · Phase 4

Conditions studied: Anxiety, Pediatric ALL, Procedural Anxiety

In brief

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).

Key facts

Study ID

NCT03043430

Run by

Brooke Army Medical Center

People needed

10

Starts

2016-05-01

Expected to finish

2023-04-01

Last updated by the study team

2023-04-25

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• San Antonio Military Medical Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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