Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Ketamine

Brief Summary

The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

Intervention / Treatment

Children who meet inclusion and exclusion criteria will be approached for participation in the study.
  • Ketamine Hcl 100Mg/Ml Inj (DRUG)
    10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation

Condition or Disease

  • Failed Moderate Sedation During Procedure
  • Ketamine Adverse Reaction

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 2 Years to 7 Years
    Enrollment: 10 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Sep 21, 2017 ACTUAL
    Primary Completion: Jan 22, 2019 ACTUAL
    Completion Date: Jan 22, 2019 ACTUAL
    Study First Posted: Mar 01, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 24, 2019

    Sponsors / Collaborators

    Lead Sponsor: University of Arizona
    Responsible Party: N/A

    Location

    Tucson, Arizona, USA

    Participant Groups

    • 10mg/kg intranasal ketamine administered one time

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 7
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
    * Body weight of 20kg or less (actual, estimated, or measured)
    * NPO for four hours or more
    * Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.

    Exclusion Criteria:

    * Discretion of parents
    * Discretion of provider
    * Body weight greater than 20kg (actual, estimated, or measured)
    * Starting Aldrete score \<9/10
    * Known or suspected psychosis
    * Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure
    * Significant elevation in blood pressure
    * Known hypersensitivity to ketamine
    * Non-English or Spanish speaking

    Primary Outcomes

    • Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

    More Details

    NCT Number: NCT03067974
    Other IDs: 1705414419
    Study URL: https://clinicaltrials.gov/study/NCT03067974
    Last updated: Sep 29, 2023