Trials / Withdrawn
WithdrawnNCT04023825
Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Academic / Other
- Sex
- All
- Age
- 5 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | suprazygomatic maxillary nerve block | in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
- First posted
- 2019-07-18
- Last updated
- 2023-03-23
Source: ClinicalTrials.gov record NCT04023825. Inclusion in this directory is not an endorsement.