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The goal of this clinical trial is to learn about the pharmacokinetics of levobupivacaine in newborns during the continus caudal epidural analgesia. This type of analgesia is used for severly ill newborns. There is a need to lower the opioid doses for this population who is undergoing the surgery due to the life threading indication. In some cases it is considered to use the epidural analgesia for the sake of the patient.
The main question is:
Is the commonly used dosing of 0,25% levobupivacaine in dose 0,2-0,3mg/kg/h the ideal dosing for these patients?
Is this type of dosing of epidural analgesia safe and effective for newborns?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PK of Levobupivacain | Other | Newborns who received epidural anesthesia with Levobupivacain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Diagnostic Test | The blood draws in specified time points |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | AE, SAE monitoring, opioid intake monitoring | 144 hours |
| Effectivity | Pain managment monitoring - Comfort Neo Scale | 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Neurotoxicity | Follow up visits with basic neurology examination | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Å Ãpek | University Hospital, Motol | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Motol | Prague | 15006 | Czechia |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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PK study
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |