Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
Sponsored by University Medical Centre Ljubljana
About This Study
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.
Conditions Studied
Interventions
- •ketamine
- •Nalbuphine
- •Dexmedetomidine
Eligibility
View full eligibility criteria
Inclusion criteria: * 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 * Slovene-speaking family to ensure understanding and compliance * No contraindications to the use of study medications Exclusion criteria: * 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 * Refusal of parental or guardian consent * Developmental disorder affecting communication or cooperation