Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

Not Applicable

Terminated

• Conditions: Sedation
• Interventions: Drug: Ketamine

• Registration Number: NCT01170247
• Lead Sponsor: University of Iowa

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 available

Study Timeline

• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-27
• Study Start: 2011-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2017-03-16
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-03
• Last Update Submitted: 2017-06-03
• Results First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Ketamine	Ketamine	-
Intramuscular Ketamine	Ketamine	-

Primary Outcome Measures

Name	Time	Method
Onset of Sedation	Every 60 seconds through study completion	Minutes it takes until the patient is cooperative enough for the procedure

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States