Comparison of the Sedative Effect of Inhaled Nitrous Oxide and Intranasal Midazolam in Behavior Management and Pain Perception of Pediatric Patients: A Split-mouth Randomized Controlled Clinical Trial
Background: Management of children has always been a challenging task in the dental office, as many children exhibit extreme fear, apprehension, and anxiety toward dental procedures. Pharmacological means of behavior management such as sedation are now at the forefront. Midazolam and nitrous oxide are the commonly employed pharmacological agents for sedation in pediatric dentistry. Though each route has its advantages and disadvantages, we compared the effect of atomized intranasal midazolam (dosage 0.3 mg/kg body weight) and nitrous oxide oxygen sedation in evaluating the behavior of child, pain experienced during local anesthesia administration, sedation level, and patient's acceptance.
Materials and methods: A total of 35 (n = 35) anxious pediatric patients aged 4–7 years with negative and definitely negative behavioral rating were randomized to receive intranasal midazolam and inhalational nitrous oxide through mask. The overall behavior, alertness, and cry were recorded using Houpt rating scale while pain and sedation were assessed by face, legs, activity, cry, and consolability (FLACC) and Ellis sedation scores, respectively.
Results: The children who received intranasal midazolam sedation were calm, had less adverse effects, and had better acceptance of the drug. Both the techniques of sedation were found to be equally effective in terms overall behavior rating.
Conclusion: Intranasal midazolam was found to be as effective as nitrous oxide sedation for controlling behavior and providing adequate sedation in pediatric dental patients. It can also be an effective alternative for anxious patients who are unable to maintain the nitrous oxide mask throughout the dental procedure.
Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent 2007;17(6):391–406. DOI: 10.1111/j.1365-263X.2007.00872.x
Wilson S, Pharmacologic behaviour management for pediatric dental treatment. Pediatr Clin North Am 2000;47(5):1159–1175. DOI: 10.1016/s0031-3955(05)70262-5
Lawrence SM, Mctigue D, Wilson S, et al. Parental attitudes toward behaviour management techniques used in pediatric dentistry. Pediatr Dent 1991;13(3):151–155.
Fields H, Machen JB, Murphy MG. Acceptability of various behaviour management techniques relative to types of dental treatment. Pediatr Dent 1984;6(4):199–203.
Coté CJ, Wilson S, American Academy of Pediatrics. American Academy of Pediatric Dentistry. Guidelines for monitoring and management of pediatric patients before during and after sedation for diagnostic and therapeutic procedures: update. Pediatrics 2016;138:e20161212. DOI: 10.1542/peds.2016-1212
Malamed SF. Sedation: A Guide to Patient Management. St. Louis Missouri: Mosby; 1995.
Roelofse JA, van der Bijl P, Comparison of rectal midazolam and diazepam for premedication in pediatric dental patients. J Oral Maxillofacial Surg 1993;51(5):525–529. DOI: 10.1016/s0278-2391(10)80507-5
Hussain AA. Mechanism of nasal absorption of drugs. Prog Clin Biol Res 1989;292:261–272.
Lee-Kim SJ, Fadavi S, Punwani I, et al. Nasal versus oral midazolam sedation for pediatric dental patients. J Dent Child (Chic) 2004;71:126–130.
Al-Rakaf H, Bello L, Turkustani A, et al. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent 2001;11:33–40. DOI: 10.1046/j.1365-263x.2001.00237.x
Bahetwar SK, Pandey RK, Saksena AK, et al. A comparative evaluation of intranasal midazolam, ketamine and their combination for sedation of young uncooperative pediatric dental patients: a triple blind randomized crossover trial. J Clin Pediatr Dent 2011;35(4):415–420. DOI: 10.17796/jcpd.35.4.l43h3354705u2574
Braham RL, Bogetz MS, Kimura M. Pharmacologic patient management in pediatric dentistry: an update. ASDC J Dent Child 2003;60(4-5):270–280.
Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. Br J Anaesth 2003;91(6):850–856. DOI: 10.1093/bja/aeg278
Torres-Pérez J, Tapia-García I, Rosales-Berber MA, et al. Comparison of three conscious sedation regimens for pediatric dental patients. J Clin Pediatr Dent 2007;31:183–186. DOI: 10.17796/jcpd.31.3.e82526q0432375n0
Papineni A, Lourenço-Matharu L, Ashley PF. Safety of oral midazolam sedation use in paediatric dentistry: a review. Int J Paediatr Dent 2014;24(1):2–13. DOI: 10.1111/ipd.12017
American Academy of Pediatric Dentistry. Guideline on use of nitrous oxide for pediatric dental patients. Pediatr Dent 2013;35(5):E174–E178.
Clark MS, Brunick A. Handbook of Nitrous Oxide and Oxygen Sedation. St. Louis: Elsevier Health Sciences; 2014.
Hosey MT, Blinkhorn AS. An evaluation of four methods of assessing the behaviour of anxious child dental patients. Int J Paediatr Dent 1995;5(2):87–95. DOI: 10.1111/j.1365-263x.1995.tb00170.x
American Academy of Pediatrics, Coté CJ, Wilson S, et al. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics, 2006;118(6):2587–2602. DOI: 10.1542/peds.2006-2780
Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs 2002;102(10):55–58. DOI: 10.1097/00000446-200210000-00024
Ellis S. Response to intravenous midazolam sedation in general dental practice. Br Dent J 1996;180:417–420. DOI: 10.1038/sj.bdj.4809108
Houpt MI, Weiss NJ, Koenigsberg SR, et al. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent 1985;7(1):41–46.
Shashikiran ND, Reddy SVV, Yavagal CM. Conscious sedation–an artist's science! An Indian experience with midazolam. J Indian Soc Pedod Prev Dent 2006;24(1):7–14. DOI: 10.4103/0970-4388.22830
Wood M. The safety and efficacy of intranasal midazolam sedation combined with inhalation sedation with nitrous oxide and oxygen in paediatric dental patients as an alternative to general anesthesia. SAAD Dig 2010;26:12–22.
Policy on the use of deep sedation and general anesthesia in the pediatric dental office. Pediatr Dent 2016b;38(6):94–95.
American Academy of Pediatric Dentistry. Guideline for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Reference manual. Pediatr Dent 2015;36:209–225.
Fuks AB, Kaufman E, Ram D, et al. Assessment of two doses of intranasal midazolam for sedation of young pediatric dental patients. Pediatr Dent 1994;16(4):301–305.
Knoester PD, Jonker DM, Van Der Hoeven RT, et al. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers. Br J Clin Pharmacol 2002;53(5):501–507. DOI: 10.1046/j.1365-2125.2002.01588.x
Veerkamp JS, Gruythuysen RJ, Hoogstraten J, et al. Anxiety reduction with nitrous oxide: a permanent solution? ASDCJ Dent Child 1995;62:44–48.
Primosch RE, Guelmann M. Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent 2005,27(5):401-408.
Wilson S. Pharmacological management of the pediatric dental patient. Pediatr Dent 2004;26(2):131–136.
Wilson KE, Girdler NM, Welbury RR. A comparison of oral midazolam and nitrous oxide sedation for dental extractions in children. Anesthesia 2006;61(12):1138–1144. DOI: 10.1111/j.1365-2044.2006.04835.x
Gilchrist F, Cairns AM, Leitch JA. The use of intranasal midazolam in the treatment of paediatric dental patients. Anesthesia 2007;62(12):1262–1265. DOI: 10.1111/j.1365-2044.2007.05260.x
Lloyd CJ, Alredy T, Lowry JC. Intranasal midazolam as an alternative to general anesthesia in the management of children with oral and maxillofacial trauma. Br J Oral Maxillofac Surg 2000;38(6):593–595. DOI: 10.1054/bjom.2000.0534
Zier JL, Liu M. Safety of high-concentration nitrous oxide by nasal mask for pediatric procedural sedation: experience with 7802 cases. Pediatr Emerg Care 2011;27(12):1107–1112. DOI: 10.1097/PEC.0b013e31823aff6d
Gentz R, Casamassimo P, Amini H, et al. Safety and efficacy of 3 pediatric midazolam moderate sedation regimens. Anesth Prog 2017;64(2):66–72. DOI: 10.2344/anpr-64-02-04
Davis I, Moore JR, Lahiri SK. Nitrous oxide and the middle ear. Anesthesia 1979;34:147–151. DOI: 10.1111/j.1365-2044.1979.tb06269.x
Orhan-Sungur M, Apfel C, Akça O. Effects of nitrous oxide on intraoperative bowel distension. Curr Opin Anaesthesiol 2005;18:620–624. DOI: 10.1097/01.aco.0000188417.00011.78