NCT03466242

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

March 1, 2018

Last Update Submit

November 19, 2025

Conditions

Conscious SedationDistal Radius Fracture

Keywords

intranasal dexmedetomidine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Compare each sedation technique for time to sedation onset

    12 months

  • Compare each sedation technique for length of sedation

    12 months

  • Compare each sedation technique for length of ED stay

    12 months

  • Compare each sedation technique for need for additional doses of medications for analgesia or sedation

    12 months

  • Compare each sedation technique for Vital sign abnormalities

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Intranasal Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

IV Ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

DexmedetomidineDRUG

Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine

Also known as: Precedex
Intranasal Dexmedetomidine
KetamineDRUG

Evaluate sedative and analgesic effects of Intravenous Ketamine

IV Ketamine

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Related Publications (26)

  • Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.

    PMID: 9165435RESULT

  • 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.

    PMID: 24279813RESULT

  • 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.

    PMID: 17067720RESULT

  • 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.

    PMID: 23110295RESULT

  • 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.

    PMID: 27212773RESULT

  • 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.

    PMID: 27380603RESULT

  • 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.

    PMID: 3670868RESULT

  • 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.

    PMID: 12472704RESULT

  • 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.

    PMID: 21318594RESULT

  • Phan H, Nahata MC. Clinical uses of dexmedetomidine in pediatric patients. Paediatr Drugs. 2008;10(1):49-69. doi: 10.2165/00148581-200810010-00006.

    PMID: 18162008RESULT

  • 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.

    PMID: 28337075RESULT

  • 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.

    PMID: 20645951RESULT

  • 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.

    PMID: 22950484RESULT

  • 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.

    PMID: 26883963RESULT

  • 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.

    PMID: 26917547RESULT

  • 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.

    PMID: 27307665RESULT

  • 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.

    PMID: 26936022RESULT

  • 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.

    PMID: 10702460RESULT

  • 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.

    PMID: 10910487RESULT

  • 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.

    PMID: 17767643RESULT

  • 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.

    PMID: 24237879RESULT

  • 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.

    PMID: 23432384RESULT

  • 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.

    PMID: 21760813RESULT

  • 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.

    PMID: 25142291RESULT

  • 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.

    PMID: 28971157RESULT

  • 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.

    PMID: 28979762RESULT

MeSH Terms

Conditions

Wrist Fractures

Interventions

DexmedetomidineKetamine

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Zebulon Timmons, MD

    Phoenix Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 15, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations

US(1)