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

Sponsor
Phoenix Children's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03466242
Collaborator
(none)
40
1
2
12
3.3

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 armThis 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
Anticipated Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
May 1, 2019

Arms and Interventions

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 Names:
  • 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

    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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Locations

    Site City State Country Postal Code
    1 Phoenix Children's Hospital Phoenix Arizona United States 85016

    Sponsors and Collaborators

    • Phoenix Children's Hospital

    Investigators

    • Principal Investigator: Zebulon Timmons, MD, Phoenix Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Mar 15, 2018
    Last Update Posted:
    Mar 15, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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, Zebulon Timmons, MD Vice section Chair of Emergency, Phoenix Children's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2018