NCT07340008 Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
| NCT ID | NCT07340008 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Orofacial Clefts |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Tadej P Dovšak, DDS, MD, PhD
STUDY CHAIR
University Medical Centre Ljubljana, Department of Maxillofacial and Oral Surgery
Frequently Asked Questions
Who can join the NCT07340008 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 3 Years, studying Orofacial Clefts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07340008 currently recruiting?
Yes, NCT07340008 is actively recruiting participants. Contact the research team at liljana.markova@kclj.si for enrollment information.
Where is the NCT07340008 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07340008 clinical trial?
NCT07340008 is sponsored by University Medical Centre Ljubljana. The principal investigator is Tadej P Dovšak, DDS, MD, PhD at University Medical Centre Ljubljana, Department of Maxillofacial and Oral Surgery. The trial plans to enroll 60 participants.