search
Back to results

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

Primary Purpose

Conscious Sedation, Distal Radius Fracture

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
Sponsored by
Phoenix Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conscious Sedation focused on measuring intranasal dexmedetomidine

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Phoenix Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intranasal Dexmedetomidine

IV Ketamine

Arm Description

Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)

Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.
Compare each sedation technique for length of ED stay
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
Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm.
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.
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.
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.
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.
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.

Full Information

First Posted
March 1, 2018
Last Updated
March 8, 2018
Sponsor
Phoenix Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03466242
Brief Title
IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Children's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conscious Sedation, Distal Radius Fracture
Keywords
intranasal dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Dexmedetomidine
Arm Type
Experimental
Arm Description
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)
Arm Title
IV Ketamine
Arm Type
Active Comparator
Arm Description
Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Evaluate sedative and analgesic effects of Intravenous Ketamine
Primary Outcome Measure Information:
Title
Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine
Description
The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system.
Time Frame
12 months
Title
Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compare each sedation technique for time to sedation onset
Description
Time in minutes and seconds from administration of sedative agent until Michigan Sedation Scoring (MSS) is 3 or higher.
Time Frame
12 months
Title
Compare each sedation technique for length of sedation
Description
Time in minutes and seconds from when Michigan Sedation Scoring (MSS) is 3 or higher until MSS is less than 3.
Time Frame
12 months
Title
Compare each sedation technique for length of ED stay
Description
Time in minutes and seconds from presentation to ED to discharge
Time Frame
12 months
Title
Compare each sedation technique for need for additional doses of medications for analgesia or sedation
Description
Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm.
Time Frame
12 months
Title
Compare each sedation technique for Vital sign abnormalities
Description
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.
Time Frame
12 months
Title
Compare each sedation technique for need for respiratory interventions
Description
Measure if any respiratory interventions were required during the patient's ED stay. Respiratory interventions defined as need for oxygen by any device.
Time Frame
12 months
Title
Compare each sedation technique for rate of vomiting
Description
Describe the incidence (yes/no) of vomiting at any point after administration of either study drug to ED discharge.
Time Frame
12 months
Title
Compare each sedation technique for procedural success rate
Description
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.
Time Frame
12 months
Title
Compare each sedation technique for patient family satisfaction
Description
Describe the family satisfaction with each conscious sedation technique. Measured by brief survey given to the family upon consent for the study.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zebulon Timmons, MD
Phone
602-933-1910
Email
ztimmons@phoenixchildrens.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brent Feudale, MD
Phone
602-933-1910
Email
bfeudale@phoenixchildrens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zebulon Timmons, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zebulon Timmons, MD
Phone
602-933-1910
Email
ztimmons@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Brent Feudale, MD
Phone
602-933-1910
Email
bfeudale@phoenixchildrens.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9165435
Citation
Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.
Results Reference
result
PubMed Identifier
24279813
Citation
Gausche-Hill M, Brown KM, Oliver ZJ, Sasson C, Dayan PS, Eschmann NM, Weik TS, Lawner BJ, Sahni R, Falck-Ytter Y, Wright JL, Todd K, Lang ES. An Evidence-based Guideline for prehospital analgesia in trauma. Prehosp Emerg Care. 2014;18 Suppl 1:25-34. doi: 10.3109/10903127.2013.844873. Epub 2013 Nov 26.
Results Reference
result
PubMed Identifier
17067720
Citation
Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25.
Results Reference
result
PubMed Identifier
23110295
Citation
Litke J, Pikulska A, Wegner T. Management of perioperative stress in children and parents. Part I--the preoperative period. Anaesthesiol Intensive Ther. 2012 Jul-Sep;44(3):165-9.
Results Reference
result
PubMed Identifier
27212773
Citation
Bhat R, Santhosh MC, Annigeri VM, Rao RP. Comparison of intranasal dexmedetomidine and dexmedetomidine-ketamine for premedication in pediatrics patients: A randomized double-blind study. Anesth Essays Res. 2016 May-Aug;10(2):349-55. doi: 10.4103/0259-1162.172340.
Results Reference
result
PubMed Identifier
27380603
Citation
Miller K, Tan X, Hobson AD, Khan A, Ziviani J, O'Brien E, Barua K, McBride CA, Kimble RM. A Prospective Randomized Controlled Trial of Nonpharmacological Pain Management During Intravenous Cannulation in a Pediatric Emergency Department. Pediatr Emerg Care. 2016 Jul;32(7):444-51. doi: 10.1097/PEC.0000000000000778.
Results Reference
result
PubMed Identifier
3670868
Citation
Fowler-Kerry S, Lander JR. Management of injection pain in children. Pain. 1987 Aug;30(2):169-175. doi: 10.1016/0304-3959(87)91072-4.
Results Reference
result
PubMed Identifier
12472704
Citation
Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002 Oct;12(8):685-9. doi: 10.1046/j.1460-9592.2002.00918.x.
Results Reference
result
PubMed Identifier
21318594
Citation
Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.
Results Reference
result
PubMed Identifier
18162008
Citation
Phan H, Nahata MC. Clinical uses of dexmedetomidine in pediatric patients. Paediatr Drugs. 2008;10(1):49-69. doi: 10.2165/00148581-200810010-00006.
Results Reference
result
PubMed Identifier
28337075
Citation
Behrle N, Birisci E, Anderson J, Schroeder S, Dalabih A. Intranasal Dexmedetomidine as a Sedative for Pediatric Procedural Sedation. J Pediatr Pharmacol Ther. 2017 Jan-Feb;22(1):4-8. doi: 10.5863/1551-6776-22.1.4.
Results Reference
result
PubMed Identifier
20645951
Citation
Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.
Results Reference
result
PubMed Identifier
22950484
Citation
Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
Results Reference
result
PubMed Identifier
26883963
Citation
Miller JW, Divanovic AA, Hossain MM, Mahmoud MA, Loepke AW. Dosing and efficacy of intranasal dexmedetomidine sedation for pediatric transthoracic echocardiography: a retrospective study. Can J Anaesth. 2016 Jul;63(7):834-41. doi: 10.1007/s12630-016-0617-y. Epub 2016 Feb 16.
Results Reference
result
PubMed Identifier
26917547
Citation
Reynolds J, Rogers A, Capehart S, Manyang P, Watcha MF. Retrospective Comparison of Intranasal Dexmedetomidine and Oral Chloral Hydrate for Sedated Auditory Brainstem Response Exams. Hosp Pediatr. 2016 Mar;6(3):166-71. doi: 10.1542/hpeds.2015-0152.
Results Reference
result
PubMed Identifier
27307665
Citation
Malhotra PU, Thakur S, Singhal P, Chauhan D, Jayam C, Sood R, Malhotra Y. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial. Contemp Clin Dent. 2016 Apr-Jun;7(2):186-92. doi: 10.4103/0976-237X.183058.
Results Reference
result
PubMed Identifier
26936022
Citation
Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.
Results Reference
result
PubMed Identifier
10702460
Citation
Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
Results Reference
result
PubMed Identifier
10910487
Citation
Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016.
Results Reference
result
PubMed Identifier
17767643
Citation
Olutoye O, Kim T, Giannoni C, Stayer S. Dexmedetomidine as an analgesic for pediatric tonsillectomy and adenoidectomy. Paediatr Anaesth. 2007 Oct;17(10):1007-8. doi: 10.1111/j.1460-9592.2007.02234.x. No abstract available.
Results Reference
result
PubMed Identifier
24237879
Citation
Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
Results Reference
result
PubMed Identifier
23432384
Citation
Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br J Clin Pharmacol. 2014 Feb;77(2):357-67. doi: 10.1111/bcp.12094.
Results Reference
result
PubMed Identifier
21760813
Citation
Lightdale JR, Mitchell PD, Fredette ME, Mahoney LB, Zgleszewski SE, Scharff L, Fox VL. A Pilot Study of Ketamine versus Midazolam/Fentanyl Sedation in Children Undergoing GI Endoscopy. Int J Pediatr. 2011;2011:623710. doi: 10.1155/2011/623710. Epub 2011 May 16.
Results Reference
result
PubMed Identifier
25142291
Citation
Rasmussen KG. Psychiatric side effects of ketamine in hospitalized medical patients administered subanesthetic doses for pain control. Acta Neuropsychiatr. 2014 Aug;26(4):230-3. doi: 10.1017/neu.2013.61.
Results Reference
result
PubMed Identifier
28971157
Citation
Parvizrad R, Pakniyat A, Malekianzadeh B, Almasi-Hashiani A. Comparing the analgesic effect of intranasal with intravenous ketamine in isolated orthopedic trauma: A randomized clinical trial. Turk J Emerg Med. 2017 Jun 23;17(3):99-103. doi: 10.1016/j.tjem.2017.05.006. eCollection 2017 Sep.
Results Reference
result
PubMed Identifier
28979762
Citation
Jonkman K, Dahan A, van de Donk T, Aarts L, Niesters M, van Velzen M. Ketamine for pain. F1000Res. 2017 Sep 20;6:F1000 Faculty Rev-1711. doi: 10.12688/f1000research.11372.1. eCollection 2017.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs