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Cleft Palate clinical trials

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NCT ID: NCT04023825 Withdrawn - Surgery Clinical Trials

Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children

Suprazyg
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. Every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. Analgesic requirement, incidence of respiratory complications, re-feeding time and the duration of hospitalization are evaluated.

NCT ID: NCT03572907 Withdrawn - Cleft Palate Clinical Trials

Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.

PETROL/TROPHIC
Start date: October 2018
Phase:
Study type: Observational

The patients in this study are all born with a cleft lip and palate. They underwent several interventions in childhood to take care of it. Professor Gleizal offered them a secondary rhinoplasty aimed at normalizing the appearance of their nose. In this malformative and multioperated context, typical nasal deformities affect the tip of the nose, which appears to be sagging and asymmetrical. Scarred soft tissues exert an important retractile force against which conventional rhinoplasty techniques often remain insufficient. The use of columellar struts makes it possible to give again projection to the tip of the nose but when this strut is made from cartilage or bone, it is absorbed with the time. Moreover, these interventions require a remote removal of the site of interest (costal cartilage, tibial crest, calvaria) which generates additional morbidity. The investigators propose an alternative using a synthetic graft of titanium. This material has been used for many years for its excellent biocompatibility and trauma resistance. 28 patients were able to benefit from this technique between March 1, 2016 and March 1, 2018. The investigators wish to evaluate the aesthetic and functional results from the patient's point of view by submitting them to one validated rhinoplasty questionnaire after the end of the patient's inclusion.

NCT ID: NCT02953145 Withdrawn - Cleft Palate Clinical Trials

The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery

Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is surgery to correct the underlying anomaly. Children born with cleft palate typically undergo surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure and the use of electrocautery (burning of the tissue). Other products are available to help lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a blood clot. When a fibrin sealant is applied there are a variety of potential benefits other than bleeding control. One of these is decreased pain post operatively It is the investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will decrease pain and enhance the recovery of children who undergo cleft palate repair. The proposed study will randomly select children undergoing cleft palate repair to have tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale will be used to score the pain of the children throughout their admission to the Stollery children's hospital. The amount of pain controlling medication required as well as time to discharge will also be recorded. Statistical analysis of the data will be performed using accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will less the amount of post operative pain experienced by children undergoing cleft palate repair.

NCT ID: NCT02915042 Withdrawn - Cleft Palate Clinical Trials

Dexmedetomidine vs Placebo for Pediatric Cleft Palate Repair

Start date: December 31, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of administering intravenous dexmedetomidine as a single preemptive dose to placebo in reducing the total 24 hour dose of opioids as measured on a weight adjusted morphine equivalent basis.

NCT ID: NCT02688634 Withdrawn - Cleft Palate Clinical Trials

The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

Cleft Palate
Start date: April 2016
Phase: N/A
Study type: Observational

Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.

NCT ID: NCT01760330 Withdrawn - Cleft Palate Clinical Trials

IV Acetaminophen in Children Undergoing Palatoplasty

Start date: December 2015
Phase: Phase 2
Study type: Interventional

This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

NCT ID: NCT01413425 Withdrawn - Clinical trials for Smith-Lemi-Opitz Syndrome

A Long-Term Study of Cholesterol Supplements for Smith-Lemli-Opitz Syndrome

Start date: June 29, 2011
Phase: N/A
Study type: Observational

Background: - Smith-Lemli-Opitz syndrome (SLOS) is a genetic disorder that prevents the body from making enough cholesterol. People who have SLOS often need to take extra cholesterol, either in food or in supplements, for their bodies to work properly. Cholesterol is very important for the brain and nervous system. Therefore SLOS is highly related to autism, mental retardation, and other brain and nervous system disorders. Not much is known about how people with SLOS handle cholesterol and how taking extra cholesterol helps them. A long-term study of people with SLOS will help answer these and other questions. Objectives: - To study the effects of a high-cholesterol diet on people with Smith-Lemli-Opitz syndrome. Eligibility: - Individuals of any age who have Smith-Lemli-Opitz syndrome. Design: - Participants will have study visits up to two times in the first year and once a year every year after that. Each visit will last between 3 and 5 days. - Participants will be screened with a physical exam, medical history, and blood and urine tests. - Participants will provide regular blood, urine, stool, saliva, and skin cell samples for testing. - Participants will keep track of the foods they eat at home. During the study, they will eat a high-cholesterol diet at all times, except for the second study visit (3 to 6 months after the screening visit). That visit will involve a cholesterol-free diet for 4 weeks. - Participants will have special cholesterol tests with blood samples at different times during the study. - At different study visits, participants will have tests of mental and physical skills (including tests for autism). They will answer questions about their diet and food habits. They will also have hearing and eye tests, body and bone measurements, and imaging studies. Not all of the tests will be done at every study. - Participants will be allowed to leave the study at any time.