Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

NCT03043430 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: C.2016.021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Pediatric ALL; Procedural Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in mYPAS

  Modified Yale preoperative anxiety scale

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

Secondary Outcomes (3)

• Change in sedation scale

  Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge

• 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

• 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

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device.

Drug: Ketamine 100 MG/ML

Midazolam

ACTIVE COMPARATOR

Midazolam 5 mg/mL concentration administered in a single administered in a single 0.3 mg/kg dose with a maximum of 5mg intranasal via mucosal atomization device.

Drug: Midazolam 5 MG/ML

Interventions

Ketamine 100 MG/ML DRUG

Administer ketamine via mucosal atomization device

Ketamine

Midazolam 5 MG/ML DRUG

Administer midazolam via mucosal atomization device

Midazolam

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (4)

• 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.

  PMID: 22688444 BACKGROUND

• 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.

  PMID: 15675259 BACKGROUND

• 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.

  PMID: 26417129 BACKGROUND

• 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.

  PMID: 24665234 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nadia M Pearson, MD

  Faculty Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Program Director for Research, EM Residency

Model Details: Subjects will be randomized to one of two treatment arms.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: May 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)