Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial

Abstract

Background:Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment.Objective:Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam–ketamine in a group of children with uncooperative behavior requiring dental treatment.Materials and Methods:This was a prospective, randomized, double-blind study that included patients 3–9 years old with American Society of Anesthesiologists-I status. About 36 children presenting early childhood caries were randomly assigned to one of three groups studied: Group MK received intranasal saline and oral midazolam (0.5 mg/kg) with ketamine (5 mg/kg) mixed in mango juice; Group DX received intranasal dexmedetomidine (1 μg/kg) and oral mango juice; and Group C received intranasal saline and oral mango juice. Patients' heart rate, blood pressure, and oxygen saturation were recorded before, during, and at the end of the procedure. Patients' behavior, sedation status, and wake up behavior were evaluated with modified observer assessment of alertness and sedation scale. Ease of treatment completion was evaluated according to Houpt scale.Results:Hemodynamic changes were statistically insignificant in Group MK and Group DX. About 75% patients in Group MK were successfully sedated as compared to 53.9% Group DX and none of the patients in Group C. Ease of treatment completion was better with Group MK as compared to Group DX and least with Group C. Around 50% patients in Group MK had postoperative complications.Conclusion:Oral midazolam–ketamine combination and intranasal dexmedetomidine evaluated in the present study can be used safely and effectively in uncooperative pediatric dental patients for producing conscious sedation.

A comparison of oral midazolam-ketamine, dexmedetomidine-fentanyl, and dexmedetomidine-ketamine combinations as sedative agents in pediatric dentistry: A triple-blinded randomized controlled trial

“…Ease of treatment completion as per the scale used was excellent in 27.33% which was less than the study by Malhotra et al ., 33.33%. [ 25 ] Findings in this study are in accordance with those of Roelofse et al .,[ 22 ] Warner et al .,[ 27 ] Lin and Durieux,[ 28 ] and Beebe et al . [ 29 ]…”

“…[ 17 18 ] In our study, 72.8% of patients were successfully sedated with MK combination. This success rate is more than Funk et al .,[ 17 ] 70%; Soleimanpour et al .,[ 19 ] 62.5%; Darlong et al .,[ 20 ] 70.8%; Majidinejad et al .,[ 21 ] 45.5%; and Roelofse et al .,[ 22 ] 40% whereas it is lesser in comparison to Barkan et al .,[ 23 ] 94%; Norambuena et al .,[ 24 ] 93.3%; Darlong et al .,[ 20 ] 79.3%; Malhotra et al ., 75%;[ 25 ] and Ghai et al .,[ 26 ] 97.96%. These differences in success rate of sedation may be attributed to different scales used for evaluation, different drug dosages, and also different criteria taken for success.…”

“…Our results showed 90.9% patients achieved improved behavior during treatment are in accordance with previous studies where sufficient anxiolysis was achieved with MK combination, that is, Warner et al ., 85%;[ 27 ] Roelofse et al ., 88%;[ 22 ] Malhotra et al ., 83.3%;[ 25 ] and Funk et al ., 90%[ 17 ] whereas 73.46% improved behavior was seen in a study by Ghai et al . [ 26 ] as the doses used in their study was lesser than that used by us.…”

Comparison of two intravenous sedation techniques for use in pediatric dentistry: A randomized controlled trial

“…22,23 In our study, no patients experienced serious adverse events in either of the sedation groups, nor did any re quire the termination of the procedure or the administra tion of any emergency medications. This finding supports the aspect of safety relating to the use of intravenous dex medetomidine, 24,25 and it is in accordance with the find ings of several other studies that utilized intravenous dex medetomidine. 26 It also confirms the benefit of the prophylactic coad ministration of atropine (an anticholinergic) as an adjunct to intravenous ketamine sedation in children.…”

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation

“…Dexmedetomidine has not been associated with respiratory depression when used alone, even during deep sedation (Ebert et al, 2000 ; Venn et al, 2000 ). It has been used successfully in pediatric patients for sedation during and after mechanical ventilation, for treating the clinical signs and symptoms of drug withdrawal, and to prevent post-operative shivering, and is well-tolerated in this patient population (Tobias, 2000 ; Tobias et al, 2003 ; Berkenbosch et al, 2005 ; Chrysostomou et al, 2006 ; Teshome et al, 2014 ; Ahmed et al, 2015 ; Malhotra et al, 2016 ). Despite its use in pediatric clinical practice, dexmedetomidine is not approved for use in children by the US Food and Drug Administration (FDA).…”