ew Dosing Systems in Paediatrics.Application to the individualization of the dose of fentanyl in patients between 1 month and 16 years of age.

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

• Registration Number: EUCTR2013-004742-41-ES
• Lead Sponsor: Kern Pharma S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-16
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Informed consent signed by parents or legal guardians. 2. Patients between 28 days and 16 years of age admitted to the PICU of Gregorio Marañón 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 PICU of the Gregorio Marañón Hospital.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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.

Study & Design

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