premedication plays an important role in allowing a smooth separation of the child from the parent . inadequate premedication can result in the child experiencing turbulent anaesthetic induction and adverse behavioural sequelae . midazolam is the most common oral premedication in children and is reportedly safe and effective both at separation and induction of anaesthesia . nasal premedication with midazolam and dexmedetomidine has been studied as alternatives to oral premedication with comparable results . however , it has poor oral bioavailability and absorption is better through the mucosal routes . the primary objective of our study was the comparison of sedation scores at separation and induction between orally administered midazolam and intranasal dexmedetomidine . this was a prospective randomised , double - blinded , comparative study conducted in sixty children of the american society of anesthesiologist ( asa ) physical status 1 and 2 , aged 212 years undergoing elective surgical procedures , during february 2012april 2014 . in a previous study by yuen et al . , 21.9% patients in midazolam group and 75% in dexmedetomidine group had satisfactory sedation scores at separation . targeting the same difference , with 95% confidence level and 80% power , minimum sample size was calculated as 17 in each group . after approval from the institutional ethics committee , sixty children presenting for surgery were randomised to receive either dexmedetomidine or midazolam . parental refusal for consent , children with a significant history of allergic disorders , asa iii or higher , those on long - term therapy with theophylline or hepatic enzyme inducing drugs were excluded . the premedication was administered 60 min before induction of anaesthesia , in the holding area in the presence of one of the parents ; after a random allocation to one of the two groups using a computer - generated sequence of random numbers in blocks of five . group a received midazolam 0.5 mg / kg ( in 15 mg / kg acetaminophen syrup ) and intranasal placebo ( 0.4 ml normal saline ) . group b received intranasal dexmedetomidine 1 g / kg 0.4 ml normal saline and 15 mg / kg oral acetaminophen syrup . owing to the non - availability of oral midazolam at the time of this study , paracetamol syrup ( 250 mg/5ml ) was used to mask the bitterness of the study medication and was used at a dose of 15 mg / kg . group b received paracetamol syrup at 15 mg / kg with distilled water to a volume of 5 ml ( 1 tsp ) . intranasal dexmedetomidine was prepared from the 100 g / ml of parenteral preparation of the drug . normal saline was added to the calculated dose to make a final volume of 0.4 ml . intranasal drug was dripped into both nostrils at 0.2 ml per nostril using 1ml syringe with child in recumbent position . individuals who were not involved in observation or administration of anaesthesia for children prepared the study drugs . heart rate ( hr ) , oxygen saturation and blood pressure were measured before and every 15 min after intranasal drug administration until transfer to the operation room . the sedation status and behaviour scores were assessed every 15 min by a blinded observer using a 6-point sedation scale and a 4-point behaviour score [ table 1 ] . at the time of induction of anaesthesia , sedation and behaviour score at the time of awakening was evaluated using a 4-point wake up score [ table 1 ] . for statistical analysis sedation , behaviour and wake up behaviour scores data analysis was performed using statistical package for the social sciences spss statistics for windows , version 20.0 software ( ibm , bengaluru , india ) . student 's t - test was applied to compare age and weight , and the chi - square test was applied to compare sex distribution . both groups were comparable with respect to age , sex , weight , duration and type of surgical procedures [ table 2 ] . the average time to induction from premedication was also comparable in groups a and b ( 55.8  6.2 min vs. 56.3  5.7 min ) . comparison of baseline mean arterial blood pressure ( map ) , hr and oxygen saturation in groups a and b showed no difference between groups . however , intraoperatively , significantly higher values of map and hr were seen in group a at 30 , 45 and 60 min [ figures 1 and 2 ] . comparison of demography and types of surgery distribution of mean arterial pressure distribution of mean heart rate the median sedation scores were higher in group a at separation ( 5 vs. 2 ) and at the time of induction ( 6 vs. 3 ) which was statistically significant ( p < 0.001 ) . compared to group a , more patients in group b were satisfactorily sedated at the time of separation ( 93.3% vs. 26.7% ) and induction [ 83.3 vs. 23.3% , table 3 and figure 3 ] . comparison of sedation , behaviour and wake up scores distribution of sedation and behaviour scores the median behaviour score in group a was higher than group b at separation and induction ( 2 vs. 1 ) . they were both in the range considered satisfactory ( 2 ) and were not significantly different between the groups at separation and induction [ table 3 and figure 3 ] . the median wake up score at the time of extubation was similar in both groups . 73.3% of patients of group a and 80.0% of group b had satisfactory scores and were comparable among groups [ table 3 and figure 3 ] . fear of painful or unpleasant procedures and separation from parents may result in untoward psychological effects . although oral premedication is effective , the bitterness may cause retching and vomiting resulting in inadequate drug dosing . midazolam has been established as an effective oral premedication in children . in doses of 0.5 mg / kg , it has been found to offer adequate sedation at separation and induction . it does not prolong recovery from anaesthesia or discharge from day care procedures . yuen et al . had concluded that an oral dose of 0.5 mg / kg midazolam was satisfactory as a premedicant and that the effect correlated more closely with 1 g / kg dexmedetomidine rather than with 0.5 g / kg dexmedetomidine intranasally . akin et al . compared the effects of intranasally administered midazolam versus dexmedetomidine administered intranasally on premedication in children undergoing elective adenotonsillectomy . they concluded that both drugs were equally effective in decreasing separation anxiety in children although mask induction appeared to be superior in the midazolam group . dexmedetomidine is a newer selective alpha-2 agonist with a site of action at the locus coeruleus . it inhibits presynaptic release of norepinephrine that is responsible for its sedative and hypnotic effects . the analgesic effects occur on account of activation of alpha-2 adrenoceptor in the descending medulla - spinal noradrenergic pathway . bradycardia and hypotension occur on account of post - synaptic activation of alpha-2 receptors in the central nervous system . the finding of electroencephalogram activity similar to natural sleep supports the easy arousability from its effects . while there is sufficient literature supporting the use of oral midazolam , less information is available on the use of dexmedetomidine . we found that a dose of 1 g / kg dexmedetomidine resulted in better sedation scores and behavioural scores at separation and induction in comparison to oral midazolam . dexmedetomidine has limited bioavailability administered orally as compared to the nasal route ; hence , we chose to compare the nasal administration of dexmedetomidine with the oral midazolam which has been accepted as a standard premedicant . although dexmedetomidine has good bioavailability through the mucosal route allowing the use of oral preparation , the effects would be manifested only if the patient made an effort to retain the drug in the mouth without swallowing . the nasal route of dexmedetomidine is not associated with irritant side effects as with intranasal midazolam . the advantages of dexmedetomidine are the absence of respiratory depression and analgesic effects ; however , the drawback could be a longer onset time for sedation in comparison with midazolam . a number of studies have compared the analgesic effects of oral midazolam with hydroxyzine and chloral hydrate . the utility of midazolam has been well established although some workers have observed better sedation with chloral hydrate in comparison with midazolam . we evaluated a lower dose of dexmedetomidine versus an accepted dose of oral midazolam to assess its applicability in paediatric premedication . the average time from drug administration to induction in our study group was 45 min in two - third of our patients . this is similar to the study by yuen et al . who concluded that at 1 g / kg dose intranasal dexmedetomidine produced satisfactory sedation scores at 30 , 45 and 60 min after administration . we found a similar profile in our patients ; although we did not measure the onset of sedation , the haemodynamic responses showed lowering of hr and blood pressure at 30 min after drug administration that correlated with the onset of sedation in our patients . yuen et al . evaluated the efficacy of intranasal dexmedetomidine in two doses 1.0 and 1.5 g / kg in 18 healthy adult volunteers and compared to a placebo . they concluded that the nasal route is convenient and safe for use and sedation occurred in 45 min with peak effect between 90 and 150 min after administration . our study was designed to primarily evaluate the efficacy of dexmedetomidine in comparison to midazolam as a premedicant in the profile of paediatric patients presenting to us for surgery . the objectives were the safety , comfort and ease of separation of the child in the holding area and behaviour at induction . we did not focus on the recovery characteristics and did not control the type and duration of surgery and anaesthesia . we also did not assess the analgesic benefits resulting in lesser fentanyl or propofol usage during anaesthesia . the scoring scales for sedation , behaviour and wake up were incorporated from the study by yuen et al . in this study , we found that children receiving dexmedetomidine had significantly lower hr and blood pressure at 30 , 45 and 60 min after drug administration in comparison with children receiving midazolam . a previous study comparing the additive effects of dexmedetomidine versus fentanyl with propofol showed that significant lowering in hr and map from baseline occurred in both groups . a study using intranasal dexmedetomidine premedication in obese adults found that dexmedetomidine reduced the hr but not map in comparison to alprazolam . the fall in hr due to dexmedetomidine has been explained by its effect on sympathetic outflow and reducing levels of epinephrine and norepinephrine . the fall in blood pressure and hr was within acceptable limits for the age of the child and did not require the use of chronotropic agents , fluids or inotropes . this could not be controlled most of the time ; however , the dexmedetomidine group appeared to be sedated from 30 min after drug administration . schmidt et al . have documented decreased sympathetic stimulation and decreased post - operative pain in the groups receiving dexmedetomidine . have shown an anaesthetic sparing effect of dexmedetomidine in patients who received infusions of dexmedetomidine undergoing spine surgery . we did not assess opioid - sparing effects of dexmedetomidine and did not analyse the surgical requirements of analgesic . the management of intraoperative conditions was at the discretion of the anaesthesiologist who managed the case . it is possible that intraoperative requirements of fentanyl and propofol were lesser in the dexmedetomidine group . all children in both groups had an uneventful recovery , and wake up scores were not different between the groups . cardiovascular stability of dexmedetomidine has been documented in several studies ; doses of 2 g / kg intranasally in children undergoing non - complex cardiac surgeries have been shown to be safe . oral dexmedetomidine was also found to have better mask acceptability in children undergoing cardiac surgery . although the map and hr were lower in the dexmedetomidine group , this was still within acceptable limits for the age of the child . the limitations in the study included failure to correlate the effects of dexmedetomidine premedication on the analgesic and anaesthetic requirements during surgery . the drugs were administered at 4560 min before surgery ; however , scheduling could not take place at the time proposed in some instances . we also did not monitor the time to onset of sedation in our study group , and the types of surgeries included were variable . the inclusion of a similar profile of surgeries along with monitoring analgesic requirements can document the additional intraoperative effect of the premedicant drugs . intranasal dexmedetomidine at a dose of 1 g / kg produces superior sedation and behavioural scores at separation and induction but normal wake up scores in comparison to oral midazolam in paediatric patients .