Oral clonidine and midazolam as premedication in pediatric anesthesia- Efficacy and outcome in comparison with oral promethagine

Abstract

Background: In most of the centers of developing country no premedication is used in cases of anesthesia in paediatric population. Many centers use oral promethagine on the night before to ensure good sleep. There is dilemma of using premedication with a fear of losing control over baby. There are controversial results regarding the effectiveness of clonidine compared with midazolam as premedication in children. Aim: The aim of this study is to evaluate the efficacy of oral clonidine and midazolam as a premedication and compare to with that of conventional promethagine in pediatric patients. Methods: This prospective randomized controlled study was carried out in Combined Military Hospital, Dhaka, among 90 children aged 2 to 7 years of ASA grade I & II scheduled for elective surgery under general anaesthesia during the period of Jan 2012 to Dec 2013. All the children were randomly divided in three groups, 30 children received only syrup promethagine as per body weight (Group-P, n=30) at night. In the study groups, after the syp promethagine at night in addition they were also given oral clonidine 4 μg/kg mixed with honey (Group-C, n=30) and midazolam 0.5 mg/kg mixed with honey (Group-M, n=30) at 60 and 20 min before separation of baby from parents lap respectively. The protocol of general anesthesia like induction, intubation, maintenance, reversal and postoperative analgesia was the same for all three groups. Patient's sedation status, separation anxiety, venipuncture, mask acceptance, anesthetics requirement, salivation, analgesia, post operative nausea vomiting (PONV) and emergence agitation were recorded by an observer blind of the patient's group. Results: Children characteristics were similar in all three groups. Children who had received clonidine as well as midazolam had more satisfactory sedation upon parent separation and less separation anxiety than promethazine; compared with midazolam & promethazine, clonidine premedication was associated with better mask acceptance; children who had received clonidine had significantly less incidence of salivation and less rescue antisialagogue; children received clonidine were better managed both intra & post operatively and needed less rescue analgesics; children who had received clonidine had significantly less episodes of PONV and also required less rescue antiemetic; incidence of emergence agitation was less in clonidine group in comparison with other two groups. Conclusion: The findings of the study suggest that both midazolam and clonidine are safe and effective as anaesthetic premedication in paediatric population. It can be concluded that oral midazolam premedication is effective as far as sedation is concern but considering multifarious anesthetic function oral clonidine is much superior premedicant. However, the risks of heart rate and blood pressure decreases, and the prolonged onset of sedation associated with clonidine should be considered. We recommend further multi-centre studies with larger samples to validate findings of our study.