Actively Recruiting
Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Sedation in Children Undergoing Suture Removal After Cleft Surgery
Led by University Medical Centre Ljubljana · Updated on 2026-01-14
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of three sedative-analgesic drugs—intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine—for 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.
CONDITIONS
Brief Title
Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 months and 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive sedation with intramuscular ketamine, intranasal nalbuphine, or intranasal dexmedetomidine prior to suture removal after cleft surgery. Vital signs and sedation levels are closely monitored during and after the procedure.
1 baseline visit and 1 follow-up visit on the same day
Trial Site Locations
Total: 1 location
1
Department of Maxillofacial and Oral Surgery, University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
L
Liljana Markova, MD, PhD
E
Eleonora Ivanova, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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