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Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

This study has been terminated.
(lack of enrollment)
Information provided by (Responsible Party):
Brett A Faine, University of Iowa Identifier:
First received: July 21, 2010
Last updated: December 11, 2012
Last verified: December 2012
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
Drug: Ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

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 ]
  • Onset of sedation [ Time Frame: Minutes it take until the patient is cooperative enough for th procedure ]

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 50
Study Start Date: January 2011
Study Completion Date: January 2012
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


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01170247

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
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

Responsible Party: Brett A Faine, Clinical Pharmacy Specialist, University of Iowa Identifier: NCT01170247     History of Changes
Other Study ID Numbers: 201006786
University of Iowa
Study First Received: July 21, 2010
Last Updated: December 11, 2012

Keywords provided by University of Iowa:
Procedural Sedation

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017