Sedation options for suture removal after cleft surgery in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.