Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment
NCT ID: NCT03827408
Last Updated: 2020-01-22
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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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2017-11-27
2019-12-22
Brief Summary
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Detailed Description
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Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Midazolam group (MDZ)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
Midazolam group (MDZ)
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
Dexmedetomidine group (DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
Dexmedetomidine group (DEX)
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
Interventions
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Midazolam group (MDZ)
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
Dexmedetomidine group (DEX)
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
Eligibility Criteria
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Inclusion Criteria
* Frankl scale score 2.
* ASA I or II physical status.
* Dental intervention under local anesthesia not requiring more than 30 minutes.
* No previous dental experience.
* Parent/guardian"s written consent.
Exclusion Criteria
* Presence of facial deformities.
* History of neurological or cognitive alterations.
* Mouth breathers.
4 Years
6 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Clinical Instructor
Principal Investigators
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Amira A El-Khatib, MSc
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Nadia A Wahba, PhD
Role: STUDY_DIRECTOR
Alexandria University
Karin ML Dowidar, PhD
Role: STUDY_DIRECTOR
Alexandria University
Tamer AM Ghoneim, PhD
Role: STUDY_DIRECTOR
Faculty of Medicine, Alexandria Univerity
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.
Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct 15;38(5):77-106.
Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.
Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.
Singh C, Pandey RK, Saksena AK, Chandra G. A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study. Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.
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.
Harbuz DK, O'Halloran M. Techniques to administer oral, inhalational, and IV sedation in dentistry. Australas Med J. 2016 Feb 29;9(2):25-32. doi: 10.4066/AMJ.2015.2543. eCollection 2016.
Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9.
Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.
Silva FC, Thuler LC. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr (Rio J). 2008 Jul-Aug;84(4):344-9. doi: 10.2223/JPED.1809.
Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.
Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
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.
Canpolat DG, Yildirim MD, Aksu R, Kutuk N, Alkan A, Cantekin K. Intravenous ketamine, propofol and propofol-ketamine combination used for pediatric dental sedation: A randomized clinical study. Pak J Med Sci. 2016 May-Jun;32(3):682-7. doi: 10.12669/pjms.323.9834.
Related Links
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American Society of Anesthesiologists. ASA Physical Status Classification System.
Other Identifiers
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IORG0008839
Identifier Type: -
Identifier Source: org_study_id
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