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
Parallel
ketamine
DrugIntramuscular administration of Ketamine at 4 mg/kg body weight for analgosedation during suture removal in children after surgery for congenital clefts. Glycopyrrolate 4 mcg/kg will be co-administered to reduce salivation.
Nalbuphine
DrugIntranasal administration of Nalbuphine at 0.5 mg/kg body weight via mucosal atomizer device (MAD) for analgosedation during suture removal after cleft surgery in children.
Dexmedetomidine
DrugIntranasal administration of Dexmedetomidine at 3 mcg/kg body weight via mucosal atomizer device (MAD) for analgosedation during suture removal after cleft surgery in children.
Time to achieve adequate sedation (Modified Ramsay Sedation Score 2-3)
Time in minutes from administration of the study drug until the child reaches adequate sedation, defined as a Ramsay Sedation Score of 2-3. Sedation is assessed every 5 minutes by a trained clinician. Unit of Measure: Minutes
Sedation depth before procedure (Modified Ramsay Sedation Scale)
Sedation depth is measured using the Modified Ramsay Sedation Scale (1 = anxious/agitated, 6 = no response; 2-3 = adequate sedation). A trained clinician assesses sedation every 5 minutes after administration of the study drug, until the start of the suture removal procedure.
Surgeon-rated ease of surgical procedure
Ease of suture removal as rated by the operating surgeon using a 5-point Likert scale (1 = very difficult, 5 = very easy). Unit of measure: Units on a scale
Time to discharge from recovery room
Time in minutes from the end of the surgical procedure until the child reaches a Modified Aldrete Score of ≥9, indicating readiness for discharge from the recovery area to the hospital ward. The Aldrete score is assessed every 5 minutes by recovery room nursing staff. Unit of Measure: Minutes
Baseline child behavior (Ohio Behavioral Rating Scale)
Child's baseline behavior assessed using the Ohio Behavioral Rating Scale (1 = calm/cooperative, 4 = combative/uncontrollable; higher scores = more difficult behavior). Unit of measure: Units on a scale
Child's response to drug administration
Child's behavioral response during study drug administration, assessed using a 4-point scale (1 = calm acceptance, 4 = severe resistance; higher scores = greater resistance). Unit of measure: Units on a scale
Child's behavior during separation from parent
Behavior assessed on a 4-point separation scale (1 = excellent/easy separation, 4 = poor/difficult separation; higher scores indicate greater distress). Unit of measure: Units on a scale
Use of rescue Sevoflurane due to inadequate sedation
Number of participants who required additional sedation using inhaled Sevoflurane due to inadequate procedural sedation or significant patient movement during suture removal. The rescue protocol includes Sevoflurane inhalation starting at 2% concentration via facemask, with titration increased by 0.5% every minute as needed, until adequate sedation is achieved to complete the procedure safely. The indication for administration is failure to maintain adequate sedation (Modified Ramsay Sedation Scale \<2 or excessive movement interfering with surgery), as assessed by the attending anesthesiologist. Unit of Measure: Number of participants
Heart rate monitoring
Heart rate (HR) will be continuously monitored and recorded every 5 minutes during sedation, every 2 minutes during the procedure, and every 5 minutes in the recovery area. Unit of Measure: Beats per minute (bpm)
Blood pressure monitoring
Systolic and diastolic blood pressure will be measured at three key time points: before sedation, during the procedure, and prior to discharge. Additional measurements will be taken in case of complications. Unit of Measure: mmHg
Oxygen saturation monitoring
Oxygen saturation (SpO₂) will be monitored continuously using pulse oximetry and documented every 5 minutes during sedation and recovery, and every 2 minutes during the procedure. From study drug administration until disch Unit of Measure: Percentage (%)
Respiratory rate monitoring
Respiratory rate will be observed and recorded at baseline, during the procedure, and in the recovery area every 5 minutes. Unit of Measure: Breaths per minute
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