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

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ClinicalTrials.gov Identifier: NCT03466242
Recruitment Status : Unknown
Verified March 2018 by Zebulon Timmons, Phoenix Children's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Zebulon Timmons, Phoenix Children's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Conscious Sedation Distal Radius Fracture Drug: Dexmedetomidine Drug: Ketamine Early Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intranasal Dexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)
 Drug: Dexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
Other Name: Precedex
Active Comparator: IV Ketamine
Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)
 Drug: Ketamine
Evaluate sedative and analgesic effects of Intravenous Ketamine


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine [ Time Frame: 12 months ]
    The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system.

  2. Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Compare each sedation technique for time to sedation onset [ Time Frame: 12 months ]
    Time in minutes and seconds from administration of sedative agent until Michigan Sedation Scoring (MSS) is 3 or higher.

  2. Compare each sedation technique for length of sedation [ Time Frame: 12 months ]
    Time in minutes and seconds from when Michigan Sedation Scoring (MSS) is 3 or higher until MSS is less than 3.

  3. Compare each sedation technique for length of ED stay [ Time Frame: 12 months ]
    Time in minutes and seconds from presentation to ED to discharge

  4. Compare each sedation technique for need for additional doses of medications for analgesia or sedation [ Time Frame: 12 months ]
    Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm.

  5. Compare each sedation technique for Vital sign abnormalities [ Time Frame: 12 months ]
    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.

  6. Compare each sedation technique for need for respiratory interventions [ Time Frame: 12 months ]
    Measure if any respiratory interventions were required during the patient's ED stay. Respiratory interventions defined as need for oxygen by any device.

  7. Compare each sedation technique for rate of vomiting [ Time Frame: 12 months ]
    Describe the incidence (yes/no) of vomiting at any point after administration of either study drug to ED discharge.

  8. Compare each sedation technique for procedural success rate [ Time Frame: 12 months ]
    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.

  9. Compare each sedation technique for patient family satisfaction [ Time Frame: 12 months ]
    Describe the family satisfaction with each conscious sedation technique. Measured by brief survey given to the family upon consent for the study.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. Under age 2 years old or patients > 18 years old
  2. Multiple Fractures
  3. Significant multisystem trauma
  4. Glasgow Coma Scale (GCS < 15)
  5. Complex fractures that aren't deemed reducible in ED
  6. Reported Allergy to Alpha -2-agonists
  7. Pregnancy
  8. Intoxication
  9. Baseline Hypotension as < 70mm Hg + 2 x age or < 90mm Hg for patients > 11 years of age
  10. Patients with prior reductions attempted at outside facilities
  11. Aberrant nasal anatomy that precludes IN medications
  12. Chronic Health issues that can affect DEX metabolism
  13. History of adverse reactions to anesthesia
  14. Patients transferred from outside facilities
  15. Open fractures
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466242


Contacts
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Contact: Zebulon Timmons, MD 602-933-1910 ztimmons@phoenixchildrens.com
Contact: Brent Feudale, MD 602-933-1910 bfeudale@phoenixchildrens.com

Locations
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United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Contact: Zebulon Timmons, MD    602-933-1910    ztimmons@phoenixchildrens.com   
Contact: Brent Feudale, MD    602-933-1910    bfeudale@phoenixchildrens.com   
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
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Principal Investigator: Zebulon Timmons, MD Phoenix Children's Hospital
More Information
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Publications of Results:

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Responsible Party: Zebulon Timmons, Zebulon Timmons, MD Vice section Chair of Emergency, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT03466242    
Other Study ID Numbers: 17-193
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zebulon Timmons, Phoenix Children's Hospital:
intranasal dexmedetomidine
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents