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Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

NCT03043430 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-04-25

No results posted yet for this study

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).

Conditions

  • Anxiety
  • Pediatric ALL
  • Procedural Anxiety

Interventions

DRUG

Ketamine 100 MG/ML

Administer ketamine via mucosal atomization device

DRUG

Midazolam 5 MG/ML

Administer midazolam via mucosal atomization device

Sponsors & Collaborators

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Nadia M Pearson, MD · Faculty Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043430 on ClinicalTrials.gov