Sedation options for suture removal after cleft surgery in young children
Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Analgosedation in Children Undergoing Suture Removal After Surgery for Congenital Clefts of the Palate, Alveolar Ridge, and Lip
This trial tests whether intramuscular ketamine, intranasal nalbuphine, or intranasal dexmedetomidine provide faster, safer, and more comfortable sedation for children aged 6 months to 3 years during suture removal after cleft surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Months to 3 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07340008 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized trial enrolling 60 children aged 6 months to 3 years who need suture removal after cleft lip, palate, or alveolar ridge surgery. Participants are randomly assigned to one of three sedative-analgesic regimens: intramuscular ketamine, intranasal nalbuphine, or intranasal dexmedetomidine. Primary outcomes include time to reach adequate sedation (Modified Ramsay Sedation Scale 2–3), surgeon-rated ease of the procedure, and time to discharge readiness (Modified Aldrete Score ≥9); secondary outcomes include baseline behavior, response to drug administration, depth of sedation, separation response, parental satisfaction, and monitoring of complications and vital signs. All medications are approved and commonly used in pediatric anesthesia, and the trial is conducted at the Department of Maxillofacial and Oral Surgery, University Medical Centre Ljubljana.
Who should consider this trial
Good fit: Children aged 6 months to 3 years with ASA physical status I–II scheduled for suture removal after congenital cleft lip, palate, or alveolar ridge surgery whose parents or guardians provide informed consent and speak Slovene are ideal candidates.
Not a fit: Children with ASA status greater than II, significant neurological, psychiatric, respiratory or developmental disorders, recent upper respiratory infection, known allergy to the study drugs, or whose families do not consent or speak Slovene are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify the quickest and safest sedation approach that improves child comfort, shortens procedure time, and speeds safe discharge after suture removal.
How similar studies have performed: All three drugs are commonly used in pediatric sedation and prior studies have shown effective sedation with ketamine, dexmedetomidine, or nalbuphine in various pediatric procedures, though direct head-to-head comparisons for suture removal after cleft surgery are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana
- Department of Maxillofacial and Oral Surgery, University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Liljana Markova, MD, PhD
- Email: liljana.markova@kclj.si
- Phone: 00 386 40 802 662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.