ew Dosing Systems in Paediatrics.Application to the individualization of the dose of fentanyl in neonatal patients.

Phase 1

• Conditions: Analgesia, sedation.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-004655-21-ES
• Lead Sponsor: Kern Pharma S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-25
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Informed consent signed by parents or legal guardians. 2. Neonatal patients between 0 and 27 days of postnatal age and >= 37 weeks of gestational age admitted to the NICU of Cruces Universitary Hospital. 3. Treatment with iv fentanyl with analgesic or sedatives purposes, or with other indications by facultative prescription. 4. First stage of fentanyl treatment following the sedoanalgesia protocol of the NICU of the Cruces Universitary Hospital.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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

1. Sepsis. 2. Liver failure. 3. Renal replacement therapy. 4 Hypersensitivity to fentanyl or opioids in general. 5. Cranioencephalic trauma, increased of intracranial pressure and/or coma.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified