Anxiety, Pediatric ALL, Procedural Anxiety
Conditions
Brief 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).
Detailed description
The intranasal route of drug delivery is commonly used in Emergency Departments (ED) in pediatric patients. Multiple trials have shown the safety of administration of intranasal ketamine, including studies performed in the ED to treat pain in pediatric patients. The use of ketamine for anxiolysis has not been directly studied; however, ketamine has been shown to have anxiolytic effect at low doses as secondary outcomes when studied. Midazolam has been established as an effective medication to provide analgesia and anxiolysis. Investigators plan to conduct a randomized, double-blinded, controlled study in the Emergency Department. Pediatric patients presenting to the ED with the need for minor procedures who meet the inclusion and exclusion criteria will be consented, and if amenable, will be enrolled. 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). Patients will be tracked for symptom improvement within the Emergency Department. The primary outcome will be change in anxiety from initial measurement to measurement 5 minutes pre-procedure using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes will include sedation level, adverse events, need for additional medications, change in pain rating, patient and/or parent/guardian satisfaction.
Interventions
Administer ketamine via mucosal atomization device
Administer midazolam via mucosal atomization device
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Medication (ketamine versus midazolam) will be drawn up in unmarked syringe and applied to the patient by mucosal atomization device by a nurse not directly involved in the investigation or the patient's care.
Intervention model description
Subjects will be randomized to one of two treatment arms.
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mYPAS | Change in score between initial measurement versus 5 minutes pre-procedure | Modified Yale preoperative anxiety scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sedation scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | University of Michigan sedation scale |
| Change in pain rating (Wong-Baker Pain Faces Rating Scale) | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | Wong-Baker Pain Faces Rating Scale |
| Change in anxiety score (Visual analogue scale) | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | Visual analogue scale |
Countries
United States
Outcome results
None listed