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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

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 15, 2018
Last Update Posted Date March 15, 2018
Estimated Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • 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.
  • 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.
  • Compare each sedation technique for length of ED stay [ Time Frame: 12 months ]
    Time in minutes and seconds from presentation to ED to discharge
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Conscious Sedation
  • Distal Radius Fracture
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
    Other Name: Precedex
  • Drug: Ketamine
    Evaluate sedative and analgesic effects of Intravenous Ketamine
Study Arms  ICMJE
  • Experimental: Intranasal Dexmedetomidine
    Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: IV Ketamine
    Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)
    Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03466242
Other Study ID Numbers  ICMJE 17-193
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zebulon Timmons, Phoenix Children's Hospital
Study Sponsor  ICMJE Phoenix Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zebulon Timmons, MD Phoenix Children's Hospital
PRS Account Phoenix Children's Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP