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New treatment option for Orofacial Clefts
Official title Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
ClinicalTrials.gov ID: NCT07340008
What this study is testing
What is ketamine?
ketamine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for orofacial clefts.
Also referred to as Ketamine Hydrochloride, Ketanest.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 3
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.