Comparing Intramuscular Ketamine, Intranasal Nalbuphine, and Dexmedetomidine for Sedation in Children Aged 6 Months to 3 Years During Suture Removal After Cleft Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three sedative-analgesic drugsintramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidinefor children aged 6 months to 3 years undergoing suture removal after cleft palate, alveolar ridge, or lip surgery. This prospective, randomized study aims to compare the time to achieve adequate sedation, ease of the surgical procedure as rated by surgeons, and time to discharge readiness. Additional goals include assessing child behavior, response to drug administration, and parental satisfaction. Participants will be randomly assigned to one of three groups one receiving intramuscular ketamine plus glycopyrrolate to reduce salivation another receiving intranasal nalbuphine via a mucosal atomizer device and the third group receiving intranasal dexmedetomidine also via mucosal atomizer. Premedication with midazolam is given 30 minutes before the procedure. If sedation is insufficient, inhaled sevoflurane may be used as rescue medication. The study uses non-invasive monitoring, with intravenous access only in emergencies. Throughout the procedure, vital signs such as heart rate, oxygen saturation, and blood pressure are continuously monitored. Sedation onset, depth, procedure duration, and recovery time are recorded. Researchers will observe potential complications and evaluate sedation quality and child responses at various stages. Parental satisfaction and surgeon ease of procedure are also assessed. The study is expected to provide evidence to improve sedation protocols for minor pediatric surgeries, with participation lasting only the short procedural and recovery period.

Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery