This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups.
The primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs.
All study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.
Age 6 months to 3 years
Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip
American Society of Anesthesiologists (ASA) physical status I or II
Written informed consent obtained from parents or legal guardians
Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine
ASA physical status greater than II
Significant neurological, psychiatric, or respiratory disorder
Active or recent upper respiratory tract infection