A new clinical trial is investigating the use of ketamine, nalbuphine, and dexmedetomidine as options for analgosedation during suture removal in pediatric patients following cleft lip or palate surgery. The study is sponsored by the University Medical Centre Ljubljana and is currently recruiting participants.
In this article
- What is the study about?
- Who is affected?
- Potential benefits of the trial
- How to participate
- FAQ
- Conclusion
- Disclaimer
- Announcement
What is the study about?
This clinical trial aims to evaluate the safety and efficacy of three pharmacologic agents—ketamine, nalbuphine, and dexmedetomidine—when used for analgosedation during suture removal in children who have undergone cleft lip or palate surgery. Orofacial clefts, including cleft lip and palate and alveolar ridge defects, require surgical interventions in early childhood, followed by careful post-operative care. Removing sutures in pediatric patients often necessitates effective sedation to ensure comfort and procedural success.
Results from this trial could inform best practices in pediatric comfort care for this specific patient group.
Who is affected?
The target population for this study includes children recovering from cleft-related surgeries, their caregivers, and the clinicians performing these procedures. Regulatory and clinical decision-makers may also find the trial outcomes critical for informing future sedation protocol guidelines in postoperative pediatrics.
Potential benefits of the trial
The study is expected to explore several important aspects of sedation:
- Improved comfort and stress reduction in pediatric patients during suture removal.
- Identification of safer and more effective sedation options tailored to children with cleft-related conditions.
- Potential for cost savings by optimizing drug use and procedural efficiency.
Additionally, if one of the tested drugs shows superiority, it could become a standard treatment option.
How to participate
The trial is currently recruiting participants through the University Medical Centre Ljubljana. Parents or guardians interested in enrolling their children can visit the official ClinicalTrials.gov page for detailed eligibility criteria and enrollment information.
Clinicians referring eligible patients are encouraged to review the study requirements to ensure alignment with patient needs.
FAQ
- What drugs are being tested?
Ketamine, nalbuphine, and dexmedetomidine are under evaluation. - What condition does this trial focus on?
The study focuses on children recovering from orofacial cleft surgery, including cleft lip and palate. - Where is the trial taking place?
The study is being conducted at the University Medical Centre Ljubljana.
Conclusion
This clinical trial could lead to advancements in pediatric sedation techniques, particularly for those dealing with post-surgical care for cleft-related conditions. By targeting improved patient experiences, the results have the potential to shape future protocols in pediatric care.
Disclaimer
This article is intended for professionals in the clinical and regulatory fields. It is for informational purposes only and does not substitute legal or medical advice.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07340008?term=medical+device