International Journal of Clinical Pediatric Dentistry

Register      Login

VOLUME 14 , ISSUE S2 ( Special Issue (Behaviour Management), 2021 ) > List of Articles

RESEARCH ARTICLE

Evaluation of Efficacy of Oral Ketamine and Midazolam Combination Drug in Different Doses in Different Groups Used for Moderate Sedation in Pediatric Dentistry Randomized-comparative Trial

Kalpana Verma

Keywords : Ketamine-midazolam, Moderate sedation, Pediatric dentistry

Citation Information :

DOI: 10.5005/jp-journals-10005-2096

License: CC BY-NC 4.0

Published Online: 01-02-2022

Copyright Statement:  Copyright © 2021; The Author(s).


Abstract

Background: Dental phobia and apprehension in children lead to difficulty with behavior management. During dental procedure if a child had a bad experience, he will develop greater apprehension, which makes further treatment difficult. Aim and objective: The aim and objective of the present study is to assess and compare the sedation and wake-up behavior status of oral combinations of three different doses of ketamine and midazolam drugs in three different groups mixed in 1 mL of honey. Methodology: This study was a randomized, clinical study that included patients ranging from 3 to 9 years of age with American Society of Anesthesiologists–I status with carious teeth, were randomly allocated among three groups where group (A) received 0.2 mg/kg of oral midazolam and 5 mg/kg oral ketamine combination drugs, group (B) received 0.3 mg/kg of oral midazolam with 3 mg/kg of oral ketamine combination drugs and group (C) received 0.4 mg/kg of oral midazolam with 2 mg/kg of oral ketamine combination drugs mixed in 1 mL of honey. Child patient's who fulfilled the inclusion criteria, heart rate, blood pressure, and oxygen saturation was recorded from starting of the treatment until discharged from the monitoring room. Ease of treatment completion was evaluated according to the Houpt scale, patients’ behavior, sedation, and wake-up behavior status were evaluated with modified observer assessment of alertness and sedation scale (MOAAS). Results: In the study, various doses of ketamine-midazolam combination drugs in three different groups resulted in a clement increase in heart rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) during the procedure but variations among the groups were not significant. As per MOAAS, the sedation success rate in group B (83.3%) was more than group A (66.6%) and group C (66.6%). All the three groups equally showed the same i.e., (91.6%), behavior score during treatment. Ease of treatment completion was excellent in group B (83.3%) followed by group A and group C [i.e.], (66.7%). Whereas, wake-up behavior score as per MOAAS scale was found to be calm and cooperative in group B (91.7%) followed by group C (88.9%) and group A (83.3%). Conclusion: In the present study oral ketamine-midazolam combination drugs can be used without harm and effectively as moderate sedation in an uncooperative pediatric patient.


PDF Share
  1. Kain ZN, Mayes LC, Caramico LA, et al. Distress during induction of anaesthesia and postoperative behavioral outcome. Anaesth Analg 1999;88(5):1042–1047. DOI: 10.1097/00000539-199905000-00013
  2. Beeby DG, Hughes JO. Behaviour of un-sedated children in the anesthetic room. Br J Anaesth 1980;52(3):279–281.DOI: 10.1093/bja/52.3.279
  3. Williams JGL, Jones JR. Psychophysiological responses to anesthesia and operation. JAMA 1968;203:127–129. Doi:10.1001/jama.1968.03140060039010
  4. Raadal M, Lundeberg S, Haukali G. Pain, pain control and sedation. In: Koch G, Poulsen S, (Eds.). Pediatric Dentistry, A Clinical Approach. (2nd ed.). Singapore: Blackwell; 2009. p. 54.
  5. Lökken P, Bakstad OJ, Fonnelöp E, et al. Conscious sedation by rectal administration of midazolam or midazolam plus ketamine as alternatives to general anesthesia for dental treatment of uncooperative children. Scand J Dent Res 1994;102(5):274–280.DOI: 10.1111/j.1600-0722.1994.tb01468.x
  6. Sekerci C, Dönmez A, Ateş Y, et al. Oral ketamine premedication in children (placebo controlled doubleblind study). Eur J Anaesthesiol 1996;13(6):606–611. DOI: 10.1046/j.1365-2346.1996.00058.x
  7. Malinovsky JM, Servin F, Cozian A, et al. Ketamine and norketamine plasma concentrations after i.v., nasal and rectal and rectal administration in children. Br J Anaesth 1996;77(2):203–207.DOI: 10.1093/bja/77.2.203
  8. Malinovsky JM, Lejus C, Servin F, et al. Plasma concentrations of midazolam after i.v., nasal or rectal administration in children. Br J Anaesth 1993;70(6):617–620. DOI: 10.1093/bja/70.6.617
  9. Warner DL, Cabaret J, Velling D. Ketamine plus midazolam, a most effective paediatric oral premedicant. Paediatr Anaesth 1995;5:293–295. DOI: 10.1111/j.1460-9592.1995.tb00307.x
  10. Kanto JH. Midazolam: The first water–soluble benzodiazepine; pharmacology, pharmacokinetics and efficacy in insomnia and anesthesia. Pharmacotherapy 1985;5:138–155. DOI: 10.1002/j.1875-9114.1985.tb03411.x
  11. Kain ZN, Mayes LC, Bell C, et al. Premedication in the United States: a status report. Anesth Analg 1997;84:427–432.DOI: 10.1097/00000539-199702000-00035
  12. McGraw T, Kendrick A. Oral midazolam premedication and postoperative behaviour in children. Paediatr Anaesth 1998;8:117–121. DOI: 10.1046/j.1460-9592.1998.00724.x
  13. Funk W, Jakob W, Riedl T, et al. Oral preanaesthetic medication for children: double–blind randomized study of a combination of midazolam and ketamine vs midazolam or ketamine alone. Br J Anaesth 2000;84:335–340. DOI: 10.1093/oxfordjournals.bja.a013435
  14. Ghai B, Grandhe RP, Kumar A, et al. Comparative evaluation of midazolam and ketamine with midazolam alone as oral premedication. Paediatr Anaesth 2005;15:554–559. DOI: 10.1111/j.1460-9592.2004.01523.x
  15. Alcaino EA. Conscious sedation in paediatric dentistry: current philosophies and techniques. Ann R Australas Coll Dent Surg 2000;15:206–210.
  16. American Society of Anesthesiologists. Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures. A Report of the American Society of Anesthesiologists. Available from: http:// www.asahq.org/publicationsAndServices/npoguide.html. [Last accessed on 2016 May 03].
  17. Chernik DA, Gillings D, Laine H, et al. Validity and reliability of the observer's assessment of alertness/sedation scale: study with intravenous midazolam. J Clin Psychopharmacol 1990;10:244–251. PMID-2286697.
  18. Astuto M, Disma N, Crimi E. Two doses of oral ketamine, given with midazolam, for premedication in children. Minerva Anestesiol 2002;68:593–598. PMID-12244290.
  19. Darlong V, Shende D, Singh M, et al. Low-versus high-dose combination of midazolam-ketamine for oral premedication in children for ophthalmologic surgeries. Singapore Med J 2011;52(7):512–516. PMID-21808963
  20. Malhotra PU, Thakur S, Singhal P, et al. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: a double-blinded randomized controlled trial. Contemp Clin Dent 2016;7:186–192.DOI: 10.4103/0976-237X.183058
  21. Jaikaria A, Thakur S, Singhal P, et al. A comparison of oral midazolam-ketamine, dexmedetomidine-fentanyl, and dexmedetomidine-ketamine combinations as sedative agents in pediatric dentistry: A triple-blinded randomized controlled trial. Contemp Clin Dent 2018;9(6):197–203. DOI: 10.4103/ccd.ccd_818_17
  22. Darlong V, Shende D, Subramanyam MS, et al. Oral ketamine or midazolam or low dose combination for premedication in children. Anaesth Intensive Care 2004;32:246–249. DOI: 10.1177/0310057x0403200214
  23. Soleimanpour H, Mahmoodpoor A, Milani FE, et al. Effectiveness of oral ketamine, midazolam, and atropine cocktail versus oral diphenhydramine for pediatric sedation in the emergency department. Iran Red Crescent Med J 2014;16(9):e21366. DOI: 10.5812/ircmj.21366
  24. Majidinejad S, Taherian K, Esmailian M, et al. Oral midazolam-ketamine versus Midazolam alone for procedural sedation of children undergoing computed tomography; a randomized clinical trial. Emerg (Tehran) 2015;3(2): 64–69. PMID-26495384.
  25. Roelofse JA, Louw LR, Roelofse PGR. A double blind randomized comparison of oral trimeprazine-methadone and ketamine midazolam for sedation of pediatric dental patients for oral surgical procedures. Anesth Prog 1998;45(1):3–11. PMID-9790003
  26. Barkan S, Breitbart R, Brenner-Zada G, et al. A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair. Emerg Med J 2014;31(8):649–653.DOI: 10.1136/emermed-2012-202189
  27. Norambuena C, Yanez J, Flores V, et al. Oral ketamine and midazolam for pediatric burn patients: a prospective, randomized, double-blind study. J Pediatr Surg 2013;48(3):629–634. DOI: 10.1016/j.jpedsurg.2012.08.018
  28. Lin C, Durieux M. Ketamine and kids: an update. Pediatr Anesth 2005;15:91–98. DOI: 10.1111/j.1460-9592.2005.01475.x
  29. Ghajari MF, Ansari G, Soleymani AA, et al. Comparison of oral and intranasal midazolam/ketamine sedation in 3-6-year-old uncooperative dental patients. J Dent Res Dent Clin Dent Prospects 2015;9(2):61–65. DOI: 10.15171/joddd.2015.013
  30. Baygin O, Bodur H, Isik B. Effectiveness of premedication agents administered prior to nitrous oxide/oxygen. Eur J Anaesthesiol 2010;27:341–346.DOI: 10.1097/EJA.0b013e3283313cdd
  31. Moreira TA, Costa PS, Costa LR, et al. Combined oral midazolam–ketamine better than midazolam alone for sedation of young children: a randomized controlled trial. Int J Paediatr Dent 2013;23:207–215.DOI: 10.1111/j.1365-263X.2012.01246.x
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.