Cleft palate is a common congenital condition in which the roof of the mouth fails to fully fuse during fetal development, affecting approximately 1 in 700 births when including cleft lip. It causes feeding difficulties in infancy, speech and language problems, dental abnormalities, and hearing issues, and typically requires a coordinated series of surgical repairs and multidisciplinary care over many years. Outcomes have improved substantially with specialized cleft teams.
What's actually going on in research
Primary surgical repair of the palate typically occurs in the first year of life, followed by additional procedures for lip, nose, bone grafting, and speech correction as the child grows. Research is focused on the timing and technique of primary repair to optimize speech outcomes while minimizing midface growth restriction — a long-standing surgical debate. Studies are also exploring tissue engineering, growth factor delivery, and prenatal interventions, as well as genetic risk factors that may guide preventive strategies for future pregnancies.
Surgical timing optimization
Trials are comparing early versus later palate repair timing to balance optimal speech development against the risk of midface hypoplasia from early surgery, a debate central to cleft surgery for decades.
Bone graft and tissue engineering
Advances in alveolar bone grafting using growth factors, stem cells, and synthetic scaffolds are in early trials to improve dental and orthodontic outcomes without donor-site morbidity from rib or hip grafts.
Speech and language interventions
Structured speech therapy programs and techniques addressing velopharyngeal insufficiency following palate repair are in trials to optimize communication outcomes with and without secondary surgery.
What to know before you search
Eligibility varies by cleft type, child's age, prior surgical history, and the specific surgical or speech intervention being studied.
What types of trials are currently open
- Surgical technique trials — Comparing palate repair methods and timing to optimize speech and facial growth outcomes.
- Bone graft alternatives — Testing growth factor-enhanced and tissue-engineered grafts for alveolar bone reconstruction.
- Speech rehabilitation trials — Evaluating structured speech therapy and velopharyngeal surgery timing for post-repair communication.
- Hearing and ENT trials — Studying ear tube placement timing and auditory rehabilitation in children with cleft-associated hearing loss.
- Genetic and prevention studies — Identifying genetic risk factors for clefting and testing periconceptional folate or supplement strategies.
Recently added Cleft Palate trials
Effect of Opioid-Free vs Opioid-Based Anesthesia on Postoperative Pain and Emergence Agitation in Children Undergoing Cleft Surgery
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. Although cognitive development is preserved, the psychosocial impact on both children and families can be significant. Anesthesia in children with clefts presents specific challenges. Airway management is often more difficult due to anatomical variations, particularly in syndromic patients and those under 1 year of age. Immature organ systems affect drug metabolism, requiring careful dose adjustment. Preoperative anxiety and stress responses are common and may contribute to complications such as laryngospasm and bronchospasm. In the postoperative period, emergence agitation (EA) and emergence delirium (ED) are frequent, with reported incidence up to 80%. These conditions are characterized by restlessness, inconsolability, and disorientation, and may result in self-injury or disruption of surgical repairs. Differentiating agitation from pain is challenging in young children due to limited communication abilities. Validated observational tools such as CHIPPS, PAEDS, and Cravero scales are used for routine clinical assessment of pain and EA/ED, although their subjective nature may limit accuracy. Therefore, evaluation of the perioperative serum cortisol, alpha-amylase, and neuropeptide Y levels will be used. These biomarkers reflect activation of the physiological stress response and indirectly indicate the presence and intensity of pain. Pain management requires a multimodal approach. While opioids remain standard, their use is associated with adverse effects such as respiratory depression, nausea, vomiting, and delayed recovery. Consequently, opioid-free (OF) strategies using different anesthetics, including ketamine and dexmedetomidine have gained attention. This prospective randomized clinical trial will compare opioid-based anesthesia with an opioid-free protocol in children undergoing cleft surgery. A total of 90 patients age of 3 months-7 years will be randomized in a 1:1 ratio. The opioid group will receive fentanyl, while the OF group will receive ketamine and dexmedetomidine; both groups will receive propofol, vecuronium, sevoflurane, and nitrous oxide. Primary outcomes are postoperative pain (CHIPPS) and emergence agitation (PAEDS, Cravero). Pain will be assessed at 5 min, 15 min, 1, 2, 12, and 24 h after extubation, whereas emergence agitation will be evaluated at 5 min, 15 min, 1 h, and 2 h post-extubation. While these scales are routinely used in clinical practice, their subjective nature necessitates additional objective assessment. Therefore, secondary outcomes include evaluation of perioperative stress markers (cortisol, alpha-amylase, neuropeptide Y) and adverse events (nausea, vomiting, pruritus, constipation, respiratory depression, altered consciousness) within 24 h. Procedures will be standardized, with morning surgeries to minimize circadian variations of the biomarkers, performed by the same team. Blood samples will be collected before and after intravenous induction. Postoperative analgesia will include paracetamol and NSAIDs, with fentanyl as rescue therapy. The study hypothesis is that opioid-free anesthesia will provide comparable or superior analgesia, reduce the incidence of emergence agitation, attenuate the stress response, and decrease opioid-related adverse effects, thereby improving overall perioperative safety and recovery in pediatric patients undergoing cleft surgery. The particular value of this study lies in the subgroup of children who will undergo at least two surgical procedures within the observation period. In these patients, each child will be exposed to both anesthetic protocols in separate procedures-once according to the randomly assigned regimen and the second time according to the alternative protocol. In this way, each patient serves as their own control, allowing for a more precise comparison of outcomes with a substantial reduction in inter-individual variability. This approach largely eliminates individual differences such as age, body weight, baseline hemodynamic status, individual sensitivity to anesthetics and analgesics, as well as variability in stress response and pain perception. Such a design enhances the internal validity of the study and enables a more reliable interpretation of the results.
Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
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. The primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs. All study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.
Find Cleft Palate trials matched specifically to you
Answer 3 quick questions and we'll show you trials that fit your situation.