Ethics
This prospective, randomized, double-blind, controlled non-inferiority study was approved by the Institutional Research Board of the Faculty of Medicine, Mansoura University, Egypt on February 12, 2022, IRB code (MS.22.01.1818). Patients were recruited after registration of the study protocol with the Pan African Clinical Trials Registry (ID: PACTR202203673199781; registration date: 30/03/2022). This study was conducted at Mansura University Children’s Hospital from April to November 2022 in accordance with the Helsinki Declaration 2013 with good clinical practice. Informed written consent was obtained from the parents or the legal guardians of participants the day before surgery.