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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.
Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam group (MDZ) | Active Comparator | Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam. |
|
| Dexmedetomidine group (DEX) | Experimental | Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine. |
|
| Combination of Midazolam and Dexmedetomidine (MDZ/DEX) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam group (MDZ) | Drug | IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facemask acceptance during drug delivery | It will be evaluated according to Zanaty & Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily) | during the sedation procedure |
| Effect of sedation on children's future behavior | Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4) | after one week in the follow-up session |
| The 'ease of treatment completion' sing separate five-point scales. | This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered. | immediately after completion of the dental treatment procedures. |
| Post-operative effects of the sedation | This will be assessed according to Modified Vernon et al. | immediately after completion of the dental treatment procedures. |
| Analgo-sedative effect of each drug | Onset of Sedation from drug administration until the onset of satisfactory sedation | during the sedation procedure (time taken from drug administration till reaching satisfactory sedation) |
| Analgo-sedative effect of each drug | Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amira A El-Khatib, MSc | Alexandria University | Principal Investigator |
| Nadia A Wahba, PhD | Alexandria University | Study Director |
| Karin ML Dowidar, PhD | Alexandria University | Study Director |
| Tamer AM Ghoneim, PhD | Faculty of Medicine, Alexandria Univerity | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25822924 | Background | 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. | |
| 28399933 | Background | 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. |
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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.
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The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.
| Dexmedetomidine group (DEX) | Drug | IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA. |
|
| Combination of Midazolam and Dexmedetomidine (MDZ/DEX) | Drug | Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.( |
|
| during the sedation procedure (after drug administration until reaching satisfactory sedation) |
| Analgo-sedative effect of each drug | The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | during local anesthesia injection to start the operative procedure |
| Analgo-sedative effect of each drug | The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry. | during the sedation procedure (from its onset till meeting discharge criteria) |
| Analgo-sedative effect of each drug. | Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded. | during the sedation procedure (from its onset till meeting discharge criteria) |
| Amnesic effect of sedative agents. | Anterograde amnesia: will be assessed according to a modification of Bulach et al. | immediately after completion of the dental treatment procedures. |
| Hemodynamic response of sedative agents. | Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer. | during the sedation procedure (from its onset till meeting discharge criteria) |
| Hemodynamic response of sedative agents. | Vital sign: Heart rate will be counted | during the sedation procedure (from its onset till meeting discharge criteria) |
| Hemodynamic response of sedative agents. | Vital sign: Oxygen saturation will be monitored using an oximeter | during the sedation procedure (from its onset till meeting discharge criteria) |
| 28206886 | Background | 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. |
| 22144928 | Background | 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. |
| 25095322 | Background | 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. |
| 25065424 | Background | 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. |
| 26936022 | Background | 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. |
| 26989448 | Background | 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. |
| 27145560 | Background | Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9. |
| 15567810 | Background | 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. |
| 18688551 | Background | 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. |
| 5939538 | Background | 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. |
| 2286697 | Background | 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. |
| 22950484 | Background | 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. |
| 27375714 | Background | 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. |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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