Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

Official Title
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Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Conditions
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Failed Moderate Sedation During Procedure, Ketamine Adverse Reaction

Intervention / Treatment
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* Drug: Ketamine Hcl 100Mg/Ml Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus Body weight of 20kg or less (actual, estimated, or measured) NPO for four hours or more Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure. Exclusion Criteria: Discretion of parents Discretion of provider Body weight greater than 20kg (actual, estimated, or measured) Starting Aldrete score <9/10 Known or suspected psychosis Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure Significant elevation in blood pressure Known hypersensitivity to ketamine Non-English or Spanish speaking

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Children who meet inclusion and exclusion criteria will be approached for participation in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal ketamine arm<br>10mg/kg intranasal ketamine administered one time | Drug: Ketamine Hcl 100Mg/Ml Inj<br>* 10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful procedural sedation | Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication. | The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, pediatric, procedural sedation