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TerminatedPhase 4

Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

NCT03043430 · Brooke Army Medical Center

Closed to entry
Status
Not accepting participants
Phase 4
Phase
10
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in mYPAS

    Measured over Change in score between initial measurement versus 5 minutes pre-procedure

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

2 Years to 12 Years
Ages
All
Sex
Not accepted
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

Where

1 study site

FacilityCityRegionCountry
San Antonio Military Medical CenterFort Sam HoustonTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03043430 on ClinicalTrials.gov →

Last updated in the registry 2023-04-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits