IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures
NCT ID: NCT03466242
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2017-01-01
2020-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intranasal Dexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)
Dexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
IV Ketamine
Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)
Ketamine
Evaluate sedative and analgesic effects of Intravenous Ketamine
Interventions
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Dexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
Ketamine
Evaluate sedative and analgesic effects of Intravenous Ketamine
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
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
2 Years
18 Years
ALL
Yes
Sponsors
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Phoenix Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Zebulon Timmons, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Children's Hospital
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Countries
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References
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Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.
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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.
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Phan H, Nahata MC. Clinical uses of dexmedetomidine in pediatric patients. Paediatr Drugs. 2008;10(1):49-69. doi: 10.2165/00148581-200810010-00006.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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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.
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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.
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.
Other Identifiers
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17-193
Identifier Type: -
Identifier Source: org_study_id
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