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Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

This study is currently recruiting participants.
Verified January 2011 by University of Iowa
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01170247
First received: July 21, 2010
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Sedation
 Drug: Ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Efficacy of sedation (Observation Scale of Behavioral Distress-Revised) [ Time Frame: Up to 60 minutes ] [ Designated as safety issue: No ]
  • Onset of sedation [ Time Frame: Minutes it take until the patient is cooperative enough for th procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to awakening [ Time Frame: Up to 60 minutes after completion of the procedure ] [ Designated as safety issue: No ]
  • Time to discharge [ Time Frame: From the time when the procedure is completed until the patient is discharged home ] [ Designated as safety issue: No ]
  • Patient satisfaction survey [ Time Frame: Approximately 24 hours after the completion of the procedure ] [ Designated as safety issue: No ]
  • Healthcare provider satisfaction survey [ Time Frame: 30 minutes after the procdure ] [ Designated as safety issue: No ]
    Rate their satisfaction for the following questions: patient toleration of the medication, onset of sedation, comfort of patient during procedure, and adverse effects.


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal Ketamine Drug: Ketamine
Intranasal Ketamine (100 mg/mL)
Active Comparator: Intramuscular Ketamine Drug: Ketamine
Intramuscular Ketamine

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170247

Contacts
Contact: Christopher Hogrefe, MD 319-384-6511 christopher-hogrefe@uiowa.edu
Contact: Brett Faine, Pharm.D. 319-356-2233 brett-faine@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Christopher Hogrefe, MD            
Principal Investigator: Brett Faine, Pharm.D.            
Sponsors and Collaborators
University of Iowa
Investigators
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
  More Information

No publications provided

Responsible Party: Christopher Hogrefe, MD, University of Iowa Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT01170247     History of Changes
Other Study ID Numbers: 201006786, University of Iowa
Study First Received: July 21, 2010
Last Updated: January 6, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Iowa:
Procedural Sedation

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

ClinicalTrials.gov processed this record on October 17, 2012