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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.
Cleft palate is the most common congenital malformation and requires early surgery given the complications it generates. The surgical site involving the upper airways and the use of morphine are providers of respiratory complications. The suprazygomatic maxillary nerve block could considerably reduce the use of morphine in the postoperative period and thus the respiratory complications in addition to an optimal comfort for the patient. The primary endpoint was to evaluate morphine consumption during the first postoperative 48 hours after cleft palate surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Patients will receive loco regional anesthesia |
|
| control group | No Intervention | Patients will not receive loco regional anesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suprazygomatic maxillary nerve block | Drug | in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of morphine consumption | The main objective of this study is to compare the consumption of morphine during the first 48 hours after cleft palate surgery in a group of patients treated by realization of a suprazygomatic maxillary nerve block, compared to a control group. | up to 48 hours after cleft palate surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of consumption of perioperative morphine | evaluation of the consumption of perioperative morphine | up to one week after cleft palate surgery |
| Measure of the number of episodes of respiratory distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu Miclo, MD | CHU Amiens | Principal Investigator |
| Emmanuel Lorne, Pr | CHU Amiens | Principal Investigator |
| Jérémie Garnier, MD | CHU Amiens | Principal Investigator |
| Marie Trujillo-Garcia, MD | CHU Amiens | Principal Investigator |
| Dimitri Santarelli, MD | CHU Amiens | Principal Investigator |
| Cica Carole Gbaguidi, MD | CHU Amiens | Principal Investigator |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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Measure of the number of episodes of respiratory distress
| up to one week after cleft palate surgery |
| Measure of the period of re-feeding | Measure of the period of re-feeding | up to one week after cleft palate surgery |
| Measure of the duration of hospitalization | Measure of the duration of hospitalization | up to one week after cleft palate surgery |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |