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Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Brett A Faine, University of Iowa
ClinicalTrials.gov Identifier:
NCT01170247
First received: July 21, 2010
Last updated: June 3, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: 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 Brett A Faine, University of Iowa:

Primary Outcome Measures:
  • Onset of Sedation [ Time Frame: Every 60 seconds through study completion ]
    Minutes it takes until the patient is cooperative enough for the procedure


Enrollment: 3
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

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT01170247

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
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

Responsible Party: Brett A Faine, Clinical Pharmacy Specialist, University of Iowa
ClinicalTrials.gov Identifier: NCT01170247     History of Changes
Other Study ID Numbers: 201006786
University of Iowa
Study First Received: July 21, 2010
Results First Received: March 16, 2017
Last Updated: June 3, 2017

Keywords provided by Brett A Faine, University of Iowa:
Procedural Sedation

Additional relevant 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

ClinicalTrials.gov processed this record on July 19, 2017