Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Study Overview
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Brief Summary
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There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Detailed Description
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There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Official Title
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Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Conditions
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Conscious Sedation Failure During Procedure

Intervention / Treatment
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* Drug: ketamine and midazolam
* Drug: etomidate, fentanyl, and lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 5-18 years extremity fracture requiring reduction with sedation in emergency department Exclusion Criteria: allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine multi-system trauma history of psychosis pregnancy illicit drug use developmental delay non-english speaker

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: ketamine and midazolam<br>ketamine and midazolam | Drug: ketamine and midazolam<br>* ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg<br>|
| Active Comparator: etomidate and fentanyl and lidocaine<br>etomidate and fentanyl and lidocaine | Drug: etomidate, fentanyl, and lidocaine<br>* etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSBD-r | Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert satisfaction scale | Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. | immediate | 
| procedural recall | Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procedural sedation, fracture reduction, pediatric emergency medicine, etomidate, ketamine, analgesia