Iranian Journal of Medical Sciences

Document Type : Original Article(s)

Authors

1 Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

2 Hazrat Zeinab Hospital, Shiraz University of Medical Sciences, Shiraz, Iran

10.30476/ijms.2023.99122.3118

Abstract

Background: The management of preoperative anxiety in pediatric patients, as well as its implications, has remained challenging for anesthesiologists. In this study, we compared the safety and efficacy of intranasal dexmedetomidine, midazolam, and ketamine as surgical premedication in children.
Methods: This double-blinded randomized clinical trial was conducted at two tertiary hospitals in January 2014, on 90 children aged between 2-7 years old. The participants’ American Society of Anesthesiologists (ASA) physical status was I or II, and they were scheduled for elective unilateral inguinal herniorrhaphy. Using the block randomization method, the patients were randomly assigned to three groups, each receiving intranasal dexmedetomidine 
(2 µg/Kg), midazolam (0.2 mg/Kg), and ketamine (8 mg/Kg) 60 min before induction of anesthesia. Anxiety and sedation state were evaluated before drug administration, and then every 10 min for the next 50 min. Parental separation anxiety, mask acceptance, postoperative agitation, pain, nausea, and vomiting were also recorded and compared between these groups. All the statistical analyses were performed using SPSS software (version 21.0). P<0.05 was considered statistically significant.
Results: Ketamine indicated the strongest sedative effect 10, 20, and 30 min after administration of premedication (P<0.001, P=0.03, P=0.01, respectively). However, dexmedetomidine was more effective than other drugs after 40 and 50 min (P<0.001). Other variables indicated no statistically significant difference.
Conclusion: In case of emergencies, intranasal ketamine, with the shortest time of action, could be administered. Intranasal dexmedetomidine, which was revealed to be the most potent drug in this study, could be administrated 40-50 min before elective pediatric surgeries.
Trial registration number: IRCT2013081614372N1.

Keywords

  1. Getahun AB, Endalew NS, Mersha AT, Admass BA. Magnitude and Factors Associated with Preoperative Anxiety Among Pediatric Patients: Cross-Sectional Study. Pediatric Health Med Ther. 2020;11:485-94. doi: 10.2147/PHMT.S288077. PubMed PMID: 33364873; PubMed Central PMCID: PMCPMC7751437.
  2. Britteon P, Cullum N, Sutton M. Association between psychological health and wound complications after surgery. Br J Surg. 2017;104:769-76. doi: 10.1002/bjs.10474. PubMed PMID: 28195304.
  3. Dave NM. Premedication and Induction of Anaesthesia in paediatric patients. Indian J Anaesth. 2019;63:713-20. doi: 10.4103/ija.IJA_491_19. PubMed PMID: 31571684; PubMed Central PMCID: PMCPMC6761781.
  4. Almenrader N, Passariello M, Coccetti B, Haiberger R, Pietropaoli P. Premedication in children: a comparison of oral midazolam and oral clonidine. Paediatr Anaesth. 2007;17:1143-9. doi: 10.1111/j.1460-9592.2007.02332.x. PubMed PMID: 17986032.
  5. Phan H, Nahata MC. Clinical uses of dexmedetomidine in pediatric patients. Paediatr Drugs. 2008;10:49-69. doi: 10.2165/00148581-200810010-00006. PubMed PMID: 18162008.
  6. Bergman SA. Ketamine: review of its pharmacology and its use in pediatric anesthesia. Anesth Prog. 1999;46:10-20. PubMed PMID: 10551055; PubMed Central PMCID: PMCPMC2148883.
  7. Abdelaziz HMM, Bakr RH, Kasem AA. Effect of intranasal dexmedetomidine or intranasal midazolam on prevention of emergence agitation in pediatric strabismus surgery: a randomized controlled study. Egyptian journal of anaesthesia. 2016;32:285-91. doi: 10.1016/j.egja.2015.11.009.
  8. 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. PubMed PMID: 30881910; PubMed Central PMCID: PMCPMC6412317.
  9. Bd V, Goyal S, Sharma A, Kothari N, Kaloria N, Sethi P, et al. Comparison of intranasal dexmedetomidine-midazolam, dexmedetomidine-ketamine, and midazolam-ketamine for premedication in paediatric patients: a double-blinded randomized trial. Anaesthesiol Intensive Ther. 2023;55:103-8. doi: 10.5114/ait.2023.129276. PubMed PMID: 37409840; PubMed Central PMCID: PMCPMC10415598.
  10. Doyle DJ, Hendrix JM, Garmon EH. American Society of Anesthesiologists Classification. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Joseph Maxwell Hendrix declares no relevant financial relationships with ineligible companies. Disclosure: Emily Garmon declares no relevant financial relationships with ineligible companies. 2023. PubMed PMID: 28722969.
  11. Akin A, Bayram A, Esmaoglu A, Tosun Z, Aksu R, Altuntas R, et al. Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthesia. Paediatr Anaesth. 2012;22:871-6. doi: 10.1111/j.1460-9592.2012.03802.x. PubMed PMID: 22268591.
  12. Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, et al. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012;67:1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. PubMed PMID: 22950484.
  13. Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, et al. Validity and reliability of the Observer’s Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990;10:244-51. PubMed PMID: 2286697.
  14. Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002;12:685-9. doi: 10.1046/j.1460-9592.2002.00918.x. PubMed PMID: 12472704.
  15. Shamim F, Ullah H, Khan FA. Postoperative pain assessment using four behavioral scales in Pakistani children undergoing elective surgery. Saudi J Anaesth. 2015;9:174-8. doi: 10.4103/1658-354X.152874. PubMed PMID: 25829906; PubMed Central PMCID: PMCPMC4374223.
  16. Wilson GA, Doyle E. Validation of three paediatric pain scores for use by parents. Anaesthesia. 1996;51:1005-7. doi: 10.1111/j.1365-2044.1996.tb14991.x. PubMed PMID: 8943588.
  17. Hosseini Jahromi SA, Hosseini Valami SM, Adeli N, Yazdi Z. Comparison of the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety: a prospective randomized clinical trial. J Anesth. 2012;26:878-82. doi: 10.1007/s00540-012-1422-6. PubMed PMID: 22688444.
  18. Tsze DS, Steele DW, Machan JT, Akhlaghi F, Linakis JG. Intranasal ketamine for procedural sedation in pediatric laceration repair: a preliminary report. Pediatr Emerg Care. 2012;28:767-70. doi: 10.1097/PEC.0b013e3182624935. PubMed PMID: 22858745.
  19. Chapter 3 - The Spectrum of Pain and Anxiety Control. In: Malamed SF, editor. Sedation (Sixth Edition): Mosby; 2018. p. 14-22. doi: 10.1016/B978-0-323-40053-4.00003-2.
  20. Mayel M, Nejad MA, Khabaz MS, Bazrafshani MS, Mohajeri E. Intranasal midazolam sedation as an effective sedation route in pediatric patients for radiologic imaging in the emergency ward: A single-blind randomized trial. Turk J Emerg Med. 2020;20:168-74. doi: 10.4103/2452-2473.297461. PubMed PMID: 33089024; PubMed Central PMCID: PMCPMC7549517.
  21. 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. doi: 10.17796/jcpd.38.3.l828585807482966. PubMed PMID: 25095322.
  22. Elshafeey AEAM, Youssef GFK, Elsalam EHA, Saleh M, Mahrose R. Comparative study between intranasal dexmedetomidine and intranasal ketamine as a premedication for anxiolysis and sedation before pediatric general anesthesia. Ain-Shams Journal of Anesthesiology. 2020;12:1-8. doi: 10.1186/s42077-020-00104-8.
  23. Shereef KM, Chaitali B, Swapnadeep S, Gauri M. Role of nebulised dexmedetomidine, midazolam or ketamine as premedication in preschool children undergoing general anaesthesia-A prospective, double-blind, randomised study. Indian J Anaesth. 2022;66:S200-S6. doi: 10.4103/ija.ija_931_21. PubMed PMID: 35874483; PubMed Central PMCID: PMCPMC9298943.
  24. Monteiro M, Cristiani F. Effect on the behaviour of dexmedetomidine as anaesthetic premedication in the paediatric population: a prospective observational study. Rev Esp Anestesiol Reanim (Engl Ed). 2021;68:179-82. doi: 10.1016/j.redar.2020.05.020. PubMed PMID: 32883525.
  25. Peng K, Wu SR, Ji FH, Li J. Premedication with dexmedetomidine in pediatric patients: a systematic review and meta-analysis. Clinics (Sao Paulo). 2014;69:777-86. doi: 10.6061/clinics/2014(11)12. PubMed PMID: 25518037; PubMed Central PMCID: PMCPMC4255070.
  26. Narendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison of intranasal ketamine and intranasal midazolam for pediatric premedication. Anesth Essays Res. 2015;9:213-8. doi: 10.4103/0259-1162.154051. PubMed PMID: 26417129; PubMed Central PMCID: PMCPMC4563959.