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Compares treatment options for Cleft Lip Palate
Official title Effect of Opioid-Free vs Opioid-Based Anesthesia on Postoperative Pain and Emergence Agitation in Children Undergoing Cleft Surgery
ClinicalTrials.gov ID: NCT07557576
What this study is testing
What is Ketamine (1 mg/kg)?
Ketamine (1 mg/kg) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cleft lip palate.
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
- Orofacial clefts are among the most common congenital malformations, affecting approximately 1 in 700-1500 live births worldwide. They are associated not only with aesthetic concerns but also with functional impairments in feeding, speech, hearing, and dentition, and may be accompanied by other systemic malformations, often requiring multiple surgical procedures and long-term multidisciplinary care.
- 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 3 to 7
You may be able to join if
- ASA physical status I-II
- Body weight \>5 kg
- Age ≥3 months for cleft lip repair and ≥9 months for cleft palate repair
- Hemoglobin \>100 g/L
You likely can't join if
- ASA physical status III-IV
- Body weight \<5 kg
- Age \<3 months for cleft lip repair or \<9 months for cleft palate repair
- Hemoglobin \<100 g/L
- Acute illness
- Respiratory infection or vaccination within 2 weeks prior to surgery
See the full eligibility criteria
- ASA physical status I-II
- Body weight \>5 kg
- Age ≥3 months for cleft lip repair and ≥9 months for cleft palate repair
- Hemoglobin \>100 g/L
- ASA physical status III-IV
- Body weight \<5 kg
- Age \<3 months for cleft lip repair or \<9 months for cleft palate repair
- Hemoglobin \<100 g/L
- Acute illness
- Respiratory infection or vaccination within 2 weeks prior to surgery
- Requirement for perioperative intensive care
The study team makes the final eligibility decision.
Where it's taking place
- Zagreb, Croatia
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, 3 months to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zagreb, Croatia. 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.