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NCT06171295: Levon
Pharmacokinetics and Pharmacodynamics of Levobupivacaine During Continuous Caudal Epidural Analgesia in Newborns
NA trial testing Blood draw in Analgesia in 24 participants. Completed in 7 July 2022.
7 July 2022
Quick facts
| Lead sponsor | University Hospital, Motol |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 24 |
| Start date | 4 February 2021 |
| Primary completion | 7 July 2022 |
| Estimated completion | 7 July 2022 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Blood draw — full drug profile →
Conditions studied
- Analgesia — all drugs for Analgesia →
Sponsor
University Hospital, Motol
Who can join
Adults 1 Hour to 5 Weeks, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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?
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06171295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06171295 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Motol
- Last refreshed: 14 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06171295.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing