Analgesic contribution of the suprazygomatic maxillary nerve block after cleft palate surgery in childre
Phase 1
- Conditions
- cleft palate repair surgery with or without upper lip surgeryTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2018-001457-28-FR
- Lead Sponsor
- CHU Amiens-Picardie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
children between 6 month and 12yo (>5kg) undergoing cleft palate repair surgery with or without upper lip surgery
Are the trial subjects under 18? yes
Number of subjects for this age range: 74
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
inappropriate age, weight <5kg, abnormal blood coagulation, local anesthetic contraindication, local infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To compare between two groups:<br>• the evaluation of the consumption of perioperative morphine<br>• the evaluation of the scales of pain at different defined times<br>• the evaluation of the number of episodes of respiratory distres<br>• the evaluation of the period of re-feeding<br>• the evaluation of the duration of hospitalization<br>• the complications due to nerve block;Main Objective: 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;Primary end point(s): amount of morphine consumed during the 48 hours post surgery;Timepoint(s) of evaluation of this end point: 48 hours postoperative
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - amount of morphine consumed during the surgery<br>- scales of pain at different defined times,<br>- the number of episodes of respiratory distress,<br>- the feed time,<br>- the length of stay;Timepoint(s) of evaluation of this end point: Between the surgery and 30 days after the surgery