A comparative evaluation of midazolam, clonidine and dexmedetomidine as oral premedicants in children: A double blind randomized clinical trial

Abstract

Objective: To evaluate and compare the efficacy of orally administered midazolam, clonidine and dexmedetomidine with regard to preoperative sedation, effect on parental separation, acceptance of face mask and recovery profile in children.

Methodology: This was a prospective, randomized, double blind clinical trial, conducted in a tertiary care hospital, in which 80 children in the age group of 1–4 years were included. The study population was divided into three groups and each group was premedicated with one of the three oral premedicants. Patients in Group-M received 0.5 mg/kg of oral midazolam 30 min before the surgery, Group-C received 4 µg/kg of oral clonidine 90 min before the surgery and Group-D received 4 µg/kg of oral dexmedetomidine 60 min before the surgery mixed in honey. In the waiting area sedation score, parental separation score, mask acceptance at induction were measured on 4 point scales. In the PACU, children were monitored for NIBP, ECG, SpO₂ and Steward Recovery Score every 15 min for 2 hours. Nausea, vomiting, shivering or other complications if any and time taken to achieve Steward Score of 6 was noted. The statistical analysis was carried out using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, version 15.0 for Windows).

Results: All the three groups had comparable sedation. Parental separation was easy for children in Group-M (96.6%) and Group-D (93.6%) while it was significantly low in Group-C (63.5%) (p=0.001). Significantly higher number (96.6%) of children in Group-M showed satisfactory mask acceptance in comparison to Group-C (45.8%) and Group-D (25.9%) (p<0.001). Recovery from anaesthesia was significantly faster in Group-M when compared with Group-C and Group-D (p<0.001).

Conclusion: Despite effective preoperative sedation (>90%) with the two alpha-2-agonists, clonidine and dexmedetomidine, parental separation and mask induction was not satisfactory as compared to midazolam.

Citation:Arora S, Saini K, Bhardwaj N. A comparative evaluation of midazolam, clonidine and dexmedetomidine as oral premedicants in children: A double blind randomized clinical trial. Anaesth Pain & Intensive Care 2014;18(4):355-60