Clinical trial NCT03043430: Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients
Official title: Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anxiety
Pediatric ALL
Procedural Anxiety
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to one of two treatment arms.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in mYPAS
timeFrame: Change in score between initial measurement versus 5 minutes pre-procedure
Secondary outcomes:
measure: Change in sedation scale
timeFrame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
measure: Change in pain rating (Wong-Baker Pain Faces Rating Scale)
timeFrame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
measure: Change in anxiety score (Visual analogue scale)
timeFrame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Faculty Physician
name: Nadia M Pearson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosseini Jahromi SA, Hosseini Valami SM, Adeli N, Yazdi Z. Comparison of the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety: a prospective randomized clinical trial. J Anesth. 2012 Dec;26(6):878-82. doi: 10.1007/s00540-012-1422-6. Epub 2012 Jun 12.
citation: Roelofse JA, Shipton EA, de la Harpe CJ, Blignaut RJ. Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison. Anesth Prog. 2004;51(4):114-21.
citation: Narendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison of intranasal ketamine and intranasal midazolam for pediatric premedication. Anesth Essays Res. 2015 May-Aug;9(2):213-8. doi: 10.4103/0259-1162.154051.
citation: Khatavkar SS, Bakhshi RG. Comparison of nasal Midazolam with Ketamine versus nasal Midazolam as a premedication in children. Saudi J Anaesth. 2014 Jan;8(1):17-21. doi: 10.4103/1658-354X.125904.