TerminatedPhase 4ketamine

Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Sponsored by Brooke Army Medical Center

NCT ID
NCT03043430
Target Enrollment
10 participants
Start Date
2016-05
Est. Completion
2023-04

About This Study

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 Studied

AnxietyPediatric ALLProcedural Anxiety

Interventions

  • Ketamine 100 MG/ML
  • Midazolam 5 MG/ML

Eligibility

Age:2 Years - 12 Years
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

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

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source