COMPARATIVE EVALUATION OF ONSET, DURATION AND SAFETY BETWEEN MIDAZOLAM, DEXMEDETOMIDINE SEDATION AND THEIR COMBINATION IN PRESCHOOLERS: A RANDOMIZED CLINICAL TRIAL | ||||
Alexandria Dental Journal | ||||
Article 8, Volume 46, Issue 1, April 2021, Page 185-192 PDF (286.14 K) | ||||
Document Type: Original Article | ||||
DOI: 10.21608/adjalexu.2020.25527.1053 | ||||
![]() | ||||
Authors | ||||
Amira ElKhatib ![]() ![]() ![]() ![]() | ||||
1Assisstant lecturer, Department of Pediatric Dentistry, Faculty of Dentistry, Kafrelsheikh University | ||||
2Professor, Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Alexandria University, Egypt | ||||
3Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University | ||||
4Department of Anesthesia and Intensive care, Faculty of Medicine, Alexandria University. | ||||
Abstract | ||||
Introduction: Dental anxiety is a global problem in pediatric dentistry. Moderate sedation is an acceptable option for uncooperative preschoolers dental patients. Objective: To compare midazolam (MDZ), dexmedetomidine (DEX) and their combination (DEX/MDZ) as sedative drugs for preschoolers undergoing dental treatment regarding onset, duration and safety of sedation. Materials and methods: The study was a three-arm randomized clinical trial with a parallel design. Seventy-two healthy uncooperative preschoolers were selected from the Faculty of Dentistry, Alexandria University, Egypt. The participants were randomly allocated into, control group received 0.5mg/kg MDZ, study group I received 5µg/kg DEX, and study group II received 0.3mg/kg MDZ followed by 3µg/kg DEX. Each child received quadrant treatment. Time until optimum sedation and recovery were recorded. Vital signs were recorded throughout the treatment session. Results: All children were comparable regarding demography, physical status and baseline vital signs (blood pressure, heart rate, and oxygen saturation). There was a statistically significant difference regarding onset and duration of the effect of sedative drugs (P=<0.001). Dexmedetomidine had the most delayed onset of action (17.08 ± 5.88 min), while DEX/ MDZ had the longest duration of action (68.13 ± 17.12). There was a significant decrease in blood pressure throughout the sedation session for all children. Children who were sedated with DEX and DEX/MDZ had a significant decrease in heart rate than children sedated with MDZ. No statistically significant effect of drugs on oxygen saturation levels was recorded. Conclusion: Midazolam, Dexmedetomidine and their combination are safe drugs during moderate sedation for children undergoing dental treatment. | ||||
Keywords | ||||
Midazolam; Dexmedetomidine; Moderate sedation; Dental sedation; Preschool children | ||||
References | ||||
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;121:167-71.
Gupta A MC, Bhatia HP, Dahiya V. Behaviour management of an anxious child. Stomatologija. 2014;16:3-6.
Silva CC LC, Areias C, Moura ̃ o J, Andrade D. . Conscious sedation vs general anesthesia in pediatric dentistry – a
review. MedicalExpress (São Paulo, online). . 2015;2:M150104. Doi.org/10.5935/MedicalExpress.2015.01.04
AAoPD. CAC-BMS. Guideline on Behavior Guidance for the Pediatric Dental Patient. Pediatr Dent. 2015 37:57-70.
Attri JP, Sharan R, Makkar V, Gupta KK, Khetarpal R, Kataria AP. Conscious Sedation: Emerging Trends in Pediatric
Dentistry. Anesth Essays Res. 2017;11:277-81.
Barends CR AA, van Minnen B, Vissink A, Visser A. Dexmedetomidine versus Midazolam in Procedural Sedation. A
Systematic Review of Efficacy and Safety. PLoS One. 2017;12:e0169525. DOI: 10.1371/journal.pone.0169525
Ghajari MF AG, Hasanbeygi L, Shayeghi S. Conscious Sedation Efficacy of 0.3 and 0.5 mg/kg Oral Midazolam for Three to Six Year-Old Uncooperative Children Undergoing Dental Treatment: A Clinical Trial. J Dent (Tehran).
2016;13:101-7.
Ghai B JK, Saxena AK, Bhatia N, Sodhi KS. Comparison of oral midazolam with intranasal dexmedetomidine
premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr
Anaesth. 2017;27:37-44.
Weerink MAS SM, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and
Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017;56:893-913.
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;24:1252-9.
Bagheri M. The Use of Midazolam in Paediatric Dentistry: A Review of the Literature. Razavi Int J Med.
2014;2:e16913. DOI: 10.5812/rijm.16913
KumariS,AgrawalN,UshaG,TalwarV,GuptaP.ComparisonofOralClonidine,OralDexmedetomidine,andOral
Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017;11:185-
91.
Oriby ME. Comparison of Intranasal Dexmedetomidine and Oral Ketamine Versus Intranasal Midazolam
Premedication for Children Undergoing Dental Rehabilitation. Anesth Pain Med. 2019;9:e85227. DOI:
10.5812/aapm.85227
ShetaSA,Al-SarheedMA,AbdelhalimAA.Intranasaldexmedetomidinevsmidazolamforpremedicationinchildren
undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth.
2014;24:181-9.
Wakita R, Kohase H, Fukayama H. A comparison of dexmedetomidine sedation with and without midazolam for
dental implant surgery. Anesth Prog. 2012;59:62-8.
Moher D HS, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. BMJ
2010;340:c869Research Methods and Reporting: CONSORT 2010 Explanation and Elaboration: updated guidelines
for reporting parallel group randomised trials. BMJ 2010;340:c869. 2010.
Faul F, Erdfelder, E., Lang, A.-G., & Buchner, A. . G*Power 3: A flexible statistical power analysis program for the
social, behavioral, and biomedical sciences. Behavior Research Methods. 2007;39:175-91.
ASA Physical Status Classification System. Available at: https://www.asahq.org/resources/clinical- information/asa-physical-status-classification-system. American Society of Anesthesiologists. Accessed on 20
JUN 2018.
Singh H RR, Kadtane S, Dalai DR, Jain CD. Techniques for the Behavior Management in Pediatric Dentistry. Int J Sci
Stud 2014;2:269-72.
Frankl SN SF, Fozels HR. Should the parent remain with the child in the dental operatory? . J Dent Child
1962;29:150-63.
Gomes HS MA, Viana KA, Batista AC, Costa PS, Daher A, Machado GC,, Sado-Filho J VL, Corrêa-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;18:172. 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;15:77-106.
Jambure N NA. Comparison of Intranasal dexmedetomidine and oral midazolam as premedication for cardiac catheterization procedure in pediatric patients. Anaesth Pain & Intensive Care. 2016;20(Suppl 1:S48-S52).Doi: 10.4103/aer.AER_119_17
Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016;32:46-9.
Dean J, Jones, J., Vinson, L. and McDonald, R. Saxen A. pharmacological behaviour managment. McDonald and
Avery's dentistry for the child and adolescent. St. Louis, Missouri: Elsevier. 2016:303-27.
WiltonNCLJRD,PanditUA.Preanestheticsedationofpreschoolchildrenusingintranasalmidazolam.Anesthesiol.
1988;69:972-5.
Canpolat DG YM, 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;32:682-7.
LiBLZN,HuangJX,QiuQQ,TianH,NiJ,SongXR,YuenVM,IrwinMG.Acomparisonofintranasaldexmedetomidine
for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016;71:522-8.
Mohite V, Baliga S, Thosar N, Rathi N. Role of dexmedetomidine in pediatric dental sedation. J Dent Anesth Pain
Med. 2019;19:83-90.
Cozzi G ML, Maximova N, Poropat F, Magnolato A, Sbisà E, Norbedo S,, Sternissa G ZD, Barbi E. Combination of
intranasal dexmedetomidine and oral midazolam as sedation for pediatric MRI. Paediatr Anaesth. 2017;27:976-7.
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;38:255-61.
MahdaviA,FallahinejadGhajariM,AnsariG,ShafieiL.IntranasalPremedicationEffectofDexmedetomidineVersus
Midazolam on the Behavior of 2-6-Year-Old Uncooperative Children in Dental Clinic. J Dent (Tehran). 2018;15:79-
85.
Yoo H, Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, et al. Mechanism-based population pharmacokinetic and
pharmacodynamic modeling of intravenous and intranasal dexmedetomidine in healthy subjects. Eur J Clin
Pharmacol. 2015;71:1197-207.
Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens K, Absalom AR, Vereecke HEM, et al. Dexmedetomidine
pharmacodynamics in healthy volunteers: 2. Haemodynamic profile. Br J Anaesth. 2017;119:211-20.
Mountain BW, Smithson L, Cramolini M, Wyatt TH, Newman M. Dexmedetomidine as a pediatric anesthetic
premedication to reduce anxiety and to deter emergence delirium. AANA J. 2011;79:219-24.
Frolich MA, Arabshahi A, Katholi C, Prasain J, Barnes S. Hemodynamic characteristics of midazolam, propofol, and
dexmedetomidine in healthy volunteers. J Clin Anesth. 2011;23:218-23.
Maaly AM HA, El Neily DA, Hamouda SA, Abdel-Razek A. Effect of premedication with clonidine, midazolam, and
dexmedetomidine on stress response and sedation in pediatric congenital cardiac surgeries. Res Opin Anesth
Intensive Care 2019;6:321-9.
Togawa E, Hanamoto H, Maegawa H, Yokoe C, Niwa H. Dexmedetomidine and Midazolam Sedation Reduces
Unexpected Patient Movement During Dental Surgery Compared With Propofol and Midazolam Sedation. J Oral
Maxillofac Surg. 2019;77:29-41.
Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of
complications. Saudi J Anaesth. 2011;5:395-410.
| ||||
Statistics Article View: 604 PDF Download: 685 |
||||