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Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

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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

Tracking Information
First Submitted Date  ICMJE February 11, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date January 28, 2019
Actual Study Start Date  ICMJE September 21, 2017
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
Official Title  ICMJE Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Failed Moderate Sedation During Procedure
  • Ketamine Adverse Reaction
Intervention  ICMJE Drug: Ketamine Hcl 100Mg/Ml Inj
10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation
Study Arms  ICMJE Experimental: Intranasal ketamine arm
10mg/kg intranasal ketamine administered one time
Intervention: Drug: Ketamine Hcl 100Mg/Ml Inj
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 22, 2019
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03067974
Other Study ID Numbers  ICMJE 1705414419
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vivienne Ng, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vivienne Ng, MD, MPH University of Arizona
PRS Account University of Arizona
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP