IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

Detailed Description
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Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes. Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.

Official Title
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IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures. Timmons Z MD, Feudale B MD Children Presenting to the ED With Distal Forearm Extremity Fractures Often Require Re-alignment Under Conscious Sedation. The Objective of This Study is to Evaluate the Sedative, and Analgesic Effects of Intranasal (IN) Dexmedetomidine (DEX) Who Undergo Conscious Sedation for Reduction of Closed Distal Forearm Fractures When Compared to Those Receiving the Standard of Care Intravenous (IV) Ketamine

Conditions
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Conscious Sedation, Distal Radius Fracture

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment. Exclusion Criteria: Under age 2 years old or patients > 18 years old Multiple Fractures Significant multisystem trauma Glasgow Coma Scale (GCS < 15) Complex fractures that aren't deemed reducible in ED Reported Allergy to Alpha -2-agonists Pregnancy Intoxication Baseline Hypotension as < 70mm Hg + 2 x age or < 90mm Hg for patients > 11 years of age Patients with prior reductions attempted at outside facilities Aberrant nasal anatomy that precludes IN medications Chronic Health issues that can affect DEX metabolism History of adverse reactions to anesthesia Patients transferred from outside facilities Open fractures

Ages Eligible for Study
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Minimum Age: 2 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
Interventional Model Description: This will be a feasibility pilot study, and as such, will be non-blinded, and utilize a convenience sample of children aged 2-18 years old requiring closed reduction under conscious sedation for distal forearm fractures. 20 children recruited in IN Dex arm and 20 children in Ketamine arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Dexmedetomidine<br>Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg) | Drug: Dexmedetomidine<br>* Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine<br>* Other names: Precedex;|
| Active Comparator: IV Ketamine<br>Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg) | Drug: Ketamine<br>* Evaluate sedative and analgesic effects of Intravenous Ketamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine | The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system. | 12 months | 
| Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine | The analgesic effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation using either the Wong-Baker scale (FACES) or Visual Analogue Scale (VAS) depending on patient age and developmental status | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare each sedation technique for time to sedation onset | Time in minutes and seconds from administration of sedative agent until Michigan Sedation Scoring (MSS) is 3 or higher. | 12 months | 
| Compare each sedation technique for length of sedation | Time in minutes and seconds from when Michigan Sedation Scoring (MSS) is 3 or higher until MSS is less than 3. | 12 months | 
| Compare each sedation technique for length of ED stay | Time in minutes and seconds from presentation to ED to discharge | 12 months | 
| Compare each sedation technique for need for additional doses of medications for analgesia or sedation | Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm. | 12 months | 
| Compare each sedation technique for Vital sign abnormalities | Review vital signs following administration of either study drug to see if any vital signs were abnormal. Abnormal vital signs will be defined as hear rate, respiratory rate, or blood pressure above or below one standard deviation for age derived norms. | 12 months | 
| Compare each sedation technique for need for respiratory interventions | Measure if any respiratory interventions were required during the patient's ED stay. Respiratory interventions defined as need for oxygen by any device. | 12 months | 
| Compare each sedation technique for rate of vomiting | Describe the incidence (yes/no) of vomiting at any point after administration of either study drug to ED discharge. | 12 months | 
| Compare each sedation technique for procedural success rate | Describe the successful reduction of orthopedic injuries in each study arm. Successful reduction defined as patient able to be discharged and not requiring admission, surgery, or secondary reduction attempts. | 12 months | 
| Compare each sedation technique for patient family satisfaction | Describe the family satisfaction with each conscious sedation technique. Measured by brief survey given to the family upon consent for the study. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal dexmedetomidine