Effect of two different doses of oral midazolam premedication on separation anxiety in children scheduled for herniotomy
Keywords:Midazolam, Premedication, Sedation, Separation anxiety
Background: Peri-operative separation anxiety in children adversely impacts on their cognitive function and behavioural outcome. The aim of the study was to assess the effect of two different doses of oral midazolam premedication on separation anxiety in paediatric patients scheduled for herniotomy.
Methods: Eighty-four eligible children aged 1-6 years, of American Society of Anesthesiologists (ASA) class I or II, scheduled for herniotomy, were randomized into two groups, A and B, of 42 each after ethical clearance and written parental consent. Children in group A and group B received 0.5 mg/kg and 0.75 mg/kg respectively of oral midazolam flavoured with paracetamol syrup, were observed, and later separated from parents at 30 min post-premedication. Premedicant acceptability was noted, and separation anxiety was assessed using the Richmond agitation sedation scale (RASS). Statistical significance was set at p<0.05.
Results: All 84 children completed the study. At 30 min post-premedication, 47.6% in group A and 19.1% in group B had light sedation, while 52.4% in group A and 80.9% in group B were moderately sedated, p=0.0001. Premedicant acceptability and agitation scores between the groups were comparable, p>0.05.
Conclusions: Oral 0.5 mg/kg and 0.75 mg/kg midazolam induced desirable sedation in children at the 30th min with comparable lower agitation scores; however, the 0.75 mg/kg dose achieved significantly faster onset and higher level of sedation in a greater proportion of the subjects.
Strauss L. Premedication in paediatrics. South Afr J Anaesth Analg. 2021;27(6):131-5.
Vaskle P, Pal R, Arora K. Efficacy and safety of two doses of oral midazolam as premedication in paediatric patients: A prospective randomized and comparative study. IOSR J Pharm 2015;5(6):46-9.
Steeds C, Orme R. Premedication. Anaesth Intens Care Med. 2006;7:393-6.
Sheta SA, Alsarheed M. Oral midazolam premedication for children undergoing general anaesthesia for dental care. Int J Pediatr. 2009;2009:274380.
Nordt SP, Clark RF. Midazolam: a review of therapeutic uses and toxicity. J Emerg Med. 1997;15(3):357-65.
Becker DE. Pharmacodynamic considerations for moderate and deep sedation. Anesth Prog. 2012;59(1):28-42.
Coté CJ, Cohen IT, Suresh S, Rabb M, Rose JB, Weldon BC, et al. A comparison of three doses of a commercially prepared oral midazolam syrup in children. Anesth Analg. 2002;94(1):37-43.
Katz DL, Jekel JF, Elmore JG, Wild DMG, Lucan SC. Sample size calculation for epidemiological studies. In: Jekel JF, eds. Jekel’s Epidemiology, Biostatistics, Preventive Medicine and Public Health. 4th ed. Philadelphia: Saunders, Elsevier; 2014: 155-160.
Stawicki SP. Sedation scales: Very useful, very underused. OPUS 12 Sci. 2007;1(2):10-2.
Pandit UA, Collier PJ, Malviya S, Voepel-Lewis T, Wagner D, Siewert MJ. Oral transmucosal midazolam premedication for preschool children. Can J Anaesth. 2001;48(2):191-5.
Phaltankar J, Shah M. Oral midazolam as pre-medication in paediatric patients. MVP J Med Sci. 2017;4(1):30-54.
Reed MD, Rodarte A, Blumer JL, Khoo KC, Akbari B, Pou S, et al. The single-dose pharmacokinetics of midazolam and its primary metabolite in pediatric patients after oral and intravenous administration. J Clin Pharmacol. 2001;41(12):1359-69.
Beirami F, Khoshfetrat M. Babaiyan S, Moghadam A. Efficacy of different doses of oral midazolam for preoperation sedation of children. Zahedan J Res Med Sci. 2016;18(5):e6671.
Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996;150(12):1238-45.
Shoroghi M, Arbabi S, Farahbakhsh F, Sheikhvatan M, Abbasi A. Perioperative effects of oral midazolam premedication in children undergoing skin laser treatment. A double-blinded randomized placebo-controlled trial. Acta Cir Bras. 2011;26(4):303-9.
Feld LH, Negus JB, White PF. Oral midazolam preanesthetic medication in pediatric outpatients. Anesthesiology. 1990;73(5):831-4.
Eaddy JL. Prescription and Over-the-Counter Medications. In: Miller PM, eds. Principles of Addiction, Comprehensive Addictive Behaviors and Disorders. Philadelphia: Elsevier; 2013: 9-10.
Kamel WY, Shoukry AA. Preoperative oral sedation with midazolam and paracetamol vs sedation nasally with midazolam and ketamine for children scheduled for dental treatment. O J Anes. 2017;7(7):184-93.
McMillan CO, Spahr-Schopfer IA, Sikich N, Hartley E, Lerman J. Premedication of children with oral midazolam. Can J Anaesth. 1992;39(6):545-50.
Rodolà F. Midazolam as an anti-emetic. Eur Rev Med Pharmacol Sci. 2006;10(3):121-6.