drugset / Trial / NCT05500599

Effects on Recovery of Children of Intravenous Formulation of Fentanyl Citrate and Midazolam Orally for Premedication

NCT05500599 ↗

Active not recruiting 60 enrolled Alexandria University
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

To study and compare the efficacy of intravenous formula of fentanyl citrate and midazolam administered orally for premedication in paediatric surgical patients. Primary objectives will be the effect of both premedicants on recovery. The secondary outcomes will be time of onset and level of sedation, acceptance of premedication, and adverse effects. Sixty paediatric patients of either sex, in the age group of 2-8 years, with the American Society of Anaesthesiologists (ASA) Physical status I, posted for elective Genito-urological surgeries under general anaesthesia (GA) will be studied after clearance from the Institutional Ethics Committee and after obtaining written informed consent from a parent or a legal guardian

Timeline

Start
2022-03-01
Primary completion
2025-05-31
Completion
2025-08-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 10 ug/kg Oral