Anesthesia & Clinical Research
Open Access

Abstract

Comparative Evaluation of Oral Transmucosal Fentanyl Citrate and Nasal Transmucosal Midazolam Spray as Premedication in Children

Namrata Paul

Context: Premedication is an integral part of anaesthetic management. An ideal premedicant drug is anxiolytic, analgesic, sedative and amnestic. It should fulfill the aims of premedication, be safe for the patient and be easily administered.

Aims: To evaluate and compare the efficacy of oral transmucosal fentanyl citrate lollipop and intranasal midazolam spray as a premedication in children by a non-invasive route and to evaluate post-operative sedation score.

Settings and design: Our study was conducted in Government Medical College, Jammu, J&K. It was a comparative clinical trial done in 3 groups (40 subjects in each). The study was approved by the Ethical committee of the Institute.

Methods and material: Children aged 5 to 10 years undergoing surgery in general anaesthesia were included in our study. Informed written consent was obtained from the parents of each child before adding the child in the study.

Statistical analysis used: Data was collected on 120 children. Variables were reported as mean and standard deviation. The difference in mean values across the groups was assessed by One-Way Analysis of Variance (ANOVA). Statistical significance of qualitative variables was assessed with the use of chi-square test. Intergroup comparisons were made post-hoc by Bonferroni’s t-test.

Results: Children who were given oral transmucosal fentanyl citrate (15 μgm/kg) were better sedated in the preoperative period, had less apprehension at venipuncture, had better mask acceptance, were calmer at emergence and post-operative period, as compared to those who were given nasal transmucosal midazolam spray (0.2 mg/kg) or nasal saline spray.

Conclusions: It was concluded that oral transmucosal fentanyl citrate, in the dose of 15 μg/kg, is superior to nasal transmucosal midazolam spray (0.2 mg/kg) in providing preoperative sedation, decreasing anxiety at the time of placement of anaesthesia mask and intravenous cannulation and lowering the level of agitation at emergence.