A comparison of midazolam, dexmedetomidine 2µg/kg and dexmedetomidine 4µg/kg as oral premedication in children, a randomized double-blinded clinical triall

Abstract

Background: The objective of this study was to analyze an oral administration of midazolam with two different doses of dexmedetomidine for premedication in paediatric patients. Methods: A prospective, randomized, double blind study. Three hundred patients, aged 1-7 years, undergoing elective surgery under general anesthesia were recruited for the study. Patients were randomized into three groups to receive oral midazolam 0.5mg/kg (group M), oral dexmedetomidine 2 µg/kg (group D2) and oral dexmedetomidine 4 µg/kg (group D4) for premedication. An observer blinded to the patient group allocation assessed level of sedation at 30 minutes after giving the premedication, ease of parental separation was assessed while shifting the patients to the operating room, mask acceptance during induction and postoperative agitation scores in post anesthesia care unit. Results: The sedation score of group D4 was significantly higher than group D2 and group M [ group D4- 4 (4,3), group D2- 2(2,2) and group M -2(3,2), H statistics = 80.4718, p < 0.00001]. The parental separation score, mask acceptance score and postoperative was also significantly better for group D4 compared to the other two group. Conclusion: These results suggest that oral dexmedetomidine 4 µg/kg is more effective than oral midazolam 0.5mg/kg and oral dexmedetomidine 2 µg/kg for premedication in children.