Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Study Overview
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Brief Summary
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This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.

Detailed Description
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The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.

Official Title
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Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Conditions
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Trauma, Fractures, Closed, Children, Only, Deep Sedation, Ketamine

Intervention / Treatment
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* Drug: Intravenous Ketamine
* Drug: Intranasal Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 1-18 years of age. American Society of Anesthesiologists (ASA) I or II Non-operative fracture requiring reduction Body weight less than or equal to 25 kg as measured by standard weighing scale Exclusion Criteria: ASA classification III or above Age less than 1 year History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder Prior allergy to ketamine Unavailable parent or guardian to provide consent Non-English speaking

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous ketamine<br>Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. | Drug: Intravenous Ketamine<br>* Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.<br>|
| Experimental: Intranasal ketamine<br>Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. | Drug: Intranasal Ketamine<br>* Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Adequate Sedation. | Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation. | Induction up to 10 minutes | 
| Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications. | From induction to discharge from sedation by emergency physician, up to 3 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Non-serious Adverse Events. | Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations. | From induction to discharge from the emergency department. | 
| Duration of Sedation Using Modified Ramsay Sedation Scale. | Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation. | From induction to discharge from sedation by the emergency physician. | 
| Duration of Emergency Department Stay. | Measured from time of arrival to emergency department to discharge order. | From arrival to emergency department to discharge order entered by emergency physician. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procedural sedation, ketamine, pediatric, fracture, intranasal, intravenous, emergency department