Comparative evaluation of intranasal dexmedetomidine and intranasal midazolam for premedication in children undergoing anaesthesia.” A one year double blind randomised controlled trail

Abstract

INTRODUCTION: Children undergoing surgical procedures can experience significant anxiety and distress during the perioperative period. The use of sedative premedication may help to reduce anxiety, minimize the emotional trauma and facilitate a smooth induction of anaesthesia. Midazolam is most commonly used as a premedication agent in children. However adverse effects such as post-operative behavioral changes, hiccups and paradoxical hyperactive reactions have been observed. Dexmedetomidine, which is a highly selective alpha-2 agonist, has sedative properties. Hence in this study we made an effort to compare intra-nasally administered midazolam and dexmedetomidine for premedication in paediatric patients. AIMS AND OBJECTIVES: This study was conducted to compare the efficacy of intranasal dexmedetomidine (1μg/kg) and intranasal midazolam (0.2 mg/kg) for premedication in paediatric age group in terms of:- Primary objective :- 1) Parental separation anxiety 2) Acceptance of anaesthesia mask Secondary objective: Occurrence of adverse events like bradycardia and desaturation. MATERIALS AND METHODS: This prospective randomised controlled study was carried out in the Department of Anaesthesiology at KLE’S Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehrunagar, Belagavi which included 60 ASA grade I and II patients between 1 to 10 years of age who underwent lower abdominal and lower limb surgeries under caudal epidural anaesthesia with sedation from January 2015 to December 2015. After obtaining ethical committee clearance and informed consent, the patients were randomly allocated into two groups (30 in each) by computer generated randomisation table to receive 0.2mg/kg intranasal Midazolam (up to a maximum 5 mg) using 1ml tuberculin syringe with atomiser in Group M and 1μg/kg Dexmedetomidine intranasally using 1ml tuberculin syringe with atomiser in Group D. The parental separation anxiety was assessed using the parental separation anxiety scale(PSAS) while shifting the patient to operating room and mask acceptance was assessed by the attending anaesthesiologist using mask acceptance scale (MAS) in operating room who is blinded to the drug given. Heart rate (HR) and oxygen saturation(SpO2) were monitored till the end of procedure. RESULTS: Demographic characteristics were comparable in both groups and there was no statistically significant difference (P > 0.05) between the groups. The mean parental separation anxiety scale (PSAS) was 1.2 + 0.40 in dexmedetomidine group and 1.6 + 0.56 in midazolam group which is statistically significant with P value of 0.003. The mean mask acceptance scores (MAS) at the time of induction was 1.7 + 0.59 in dexmedetomidine group and 2.1 + 0.58 in midazolam group which is statistically significant(P=0.020). Only 2(6.6%) children in dexmedetomidine group had MAS > 2 when compared to 6(20%) children in midazolam group. CONCLUSION: We conclude that intranasal dexmedetomidine 1 μg/kg is an effective and safe alternative for premedication in children undergoing lower abdominal surgeries under caudal epidural anaesthesia and it resulted in lower anxiety levels, allowed better parent separation and resulted in better mask acceptance at the time of induction when compared with intranasal midazolam 0.2 mg/kg without causing much side effects or post-operative complications.