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Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

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: NCT01170247
Recruitment Status : Terminated (lack of enrollment)
First Posted : July 27, 2010
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Brett A Faine, University of Iowa

Tracking Information
First Submitted Date  ICMJE July 21, 2010
First Posted Date  ICMJE July 27, 2010
Results First Submitted Date  ICMJE March 16, 2017
Results First Posted Date  ICMJE July 2, 2017
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2017)
Onset of Sedation [ Time Frame: Every 60 seconds through study completion ]
Minutes it takes until the patient is cooperative enough for the procedure
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
  • Efficacy of sedation (Observation Scale of Behavioral Distress-Revised) [ Time Frame: Up to 60 minutes ]
  • Onset of sedation [ Time Frame: Minutes it take until the patient is cooperative enough for th procedure ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
  • Time to awakening [ Time Frame: Up to 60 minutes after completion of the procedure ]
  • Time to discharge [ Time Frame: From the time when the procedure is completed until the patient is discharged home ]
  • Patient satisfaction survey [ Time Frame: Approximately 24 hours after the completion of the procedure ]
  • Healthcare provider satisfaction survey [ Time Frame: 30 minutes after the procdure ]
    Rate their satisfaction for the following questions: patient toleration of the medication, onset of sedation, comfort of patient during procedure, and adverse effects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients
Official Title  ICMJE Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study
Brief Summary The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sedation
Intervention  ICMJE
  • Drug: Ketamine
    Intranasal Ketamine (100 mg/mL)
  • Drug: Ketamine
    Intramuscular Ketamine
Study Arms  ICMJE
  • Experimental: Intranasal Ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: Intramuscular Ketamine
    Intervention: Drug: Ketamine
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: June 3, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2010)
50
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • pediatric patients age 2 to 17 years old
  • have a laceration of 4 cm on the face or 7 cm on the remainder of the body
  • Require procedural sedation to repair the laceration

Exclusion Criteria:

  • Patients with abnormal nasal physiology which would not allow for adequate medication delivery
  • Unable to have a guardian present to consent on their behalf
  • Allergy to ketamine
  • Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
  • Presenting with a head injury associated with possible intracranial hypertension
  • Pregnancy
  • Lacerations that require repair from a consult service
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01170247
Other Study ID Numbers  ICMJE 201006786
University of Iowa
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brett A Faine, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Hogrefe, MD University of Iowa
Principal Investigator: Brett Faine, Pharm.D. University of Iowa
Principal Investigator: Andrew Nugent, MD University of Iowa
PRS Account University of Iowa
Verification Date June 2017

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