Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

University of Iowa

Status: Terminated

Conditions: Sedation

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01170247

201006786

University of Iowa

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups

Intranasal Ketamine

Experimental group

Treatment:

Drug: Ketamine

Drug: Ketamine

Intramuscular Ketamine

Active Comparator group

Treatment:

Drug: Ketamine

Drug: Ketamine