Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intranasal Ketamine

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Intranasal Ketamine (100 mg/mL)

Intramuscular Ketamine

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Intramuscular Ketamine

Interventions

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Ketamine

Intranasal Ketamine (100 mg/mL)

Intervention Type DRUG

Ketamine

Intramuscular Ketamine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes