Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03067974
Recruitment Status : Terminated (Initial results did not show benefit.)
First Posted : March 1, 2017
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Vivienne Ng, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Failed Moderate Sedation During Procedure Ketamine Adverse Reaction Drug: Ketamine Hcl 100Mg/Ml Inj Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Children who meet inclusion and exclusion criteria will be approached for participation in the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intranasal ketamine arm
10mg/kg intranasal ketamine administered one time
Drug: Ketamine Hcl 100Mg/Ml Inj
10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation




Primary Outcome Measures :
  1. Successful procedural sedation [ Time Frame: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior). ]
    Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067974


Locations
Layout table for location information
United States, Arizona
Banner Univsersity Medical Center Tucson
Tucson, Arizona, United States, 85719
Sponsors and Collaborators
University of Arizona
Investigators
Layout table for investigator information
Principal Investigator: Vivienne Ng, MD, MPH University of Arizona

Layout table for additonal information
Responsible Party: Vivienne Ng, Physician, University of Arizona
ClinicalTrials.gov Identifier: NCT03067974     History of Changes
Other Study ID Numbers: 1705414419
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Vivienne Ng, University of Arizona:
ketamine
pediatric
procedural sedation

Additional relevant MeSH terms:
Layout table for MeSH terms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action