Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

June 3, 2017 updated by: Brett A Faine, University of Iowa

Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal Ketamine
Drug: Ketamine
Intranasal Ketamine (100 mg/mL)
Drug: Ketamine
Intramuscular Ketamine
Active Comparator: Intramuscular Ketamine
Drug: Ketamine
Intranasal Ketamine (100 mg/mL)
Drug: Ketamine
Intramuscular Ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of Sedation
Time Frame: Every 60 seconds through study completion
Minutes it takes until the patient is cooperative enough for the procedure
Every 60 seconds through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Brett Faine, Pharm.D., University of Iowa
  • Principal Investigator: Andrew Nugent, MD, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201006786
  • University of Iowa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedation

Clinical Trials on Ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe