Comparison of oral triclofos and oral midazolam as premedication in children undergoing elective surgery

Background: Children who have experienced previous hospital admission, operation, procedures, and needle pricks are more reactive to subsequent anesthetic procedures. Many sedative agents have been used for the purpose of premedication, but few of them can be given orally, thus avoiding the pricks. Midazolam, being one such choices, can be given orally, intranasally, and parenterally but has unpredictable response. Triclofos, available as sweet syrup, is a phosphorylated derivative of chloral hydrate, has been proven to be effective within 30 min in doses of 25–75 mg/kg. Hence, this study compares triclofos hydrochloride with midazolam oral to know the efficacy of both the drugs as premedication. Aim: This study aims to assess sedation score, level of anxiety/resistance, and behavior of the child in the preoperative period. Settings and Design: After parental and institutional approval, a total of 70 children were studied based on computer-generated randomization and divided into groups M and T of 35 each. Materials and Methods: Group M patients received oral midazolam 0.5 mg/kg. Group T patients received commercially available triclofos syrup containing 100 mg/ml of drug in dose of 75 mg/kg. The response of children to taste of premedication was noted, whether completely ingested or not. In case of vomiting, the child was excluded from further study. Statistical Analysis: Numerical variables were analyzed using Student's paired t-test and other variables using Mann–Whitney U-test, Fisher exact test, and Friedman ANOVA. Results: Sedation score at 5 min interval from 0 to 30 min showed P = 0.54, 0.71, 0.65, 0.92, 0.29, 0.42, and 0.15; none were statistically significant. Anxiety score during parental separation, intravenous cannulation, and mask application were also similar in both the groups. Conclusion: data obtained, it can be concluded that parenteral formulation of either midazolam or triclofos can be safely used as premedicant in children.