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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05805241
Other study ID # RC 31/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 7, 2023
Est. completion date March 15, 2026

Study information

Verified date April 2023
Source IRCCS Burlo Garofolo
Contact Laura Travan, MD
Phone +390403785505
Email laura.travan@burlo.trieste.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fentanyl is an opioid drug used as analgesic and anaesthetic also in Neonatal Intensive Care Units (NICU), according to the last national and international recommendations, during invasive life support strategies such as mechanical ventilation. Opioids manifest their sedative effect through activation of μ-opioid receptors, which are abundant both in the central and peripheral nervous system. Comparing fentanyl to morphine we can appreciate a much more powerful effect (75-220 major) with lower doses to obtain similar analgesic effect; these characteristics are due to the high lipophilicity of the molecule which easily crosses the blood-brain barrier (BBB). At the same time, fentanyl shows less adverse effects than morphine such as vomiting, nausea, gastrointestinal constipation, respiratory depression, dependence and tolerance. The drug is extensively metabolized by liver enzymes. In routinary clinical practice it has been observed that large interindividual differences are found in the daily dosages needed to achieve pain control. Literature evidences that pharmacodynamic variation related to genotypes in receptor signalling or pain modulators may play an important role in this variability. Many genes are related to fentanyl pharmacodynamics and pharmacokinetics. Some polymorphism in these genes are already known to correlate with toxicity or efficacy of the drug, also in the paediatric population. More polymorphisms could be involved in abnormal pharmacodynamic or pharmacokinetics of fentanyl, therefore studies are necessary to better explain the possible role of pharmacogenetics in precision medicine especially in a very specific population as newborn.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date March 15, 2026
Est. primary completion date March 15, 2026
Accepts healthy volunteers No
Gender All
Age group 1 Day to 28 Days
Eligibility Inclusion Criteria: 1. all newborns on mechanical ventilation receiving fentanyl 2. parental written informed consent for participation in the study must be obtained Exclusion Criteria: 1. Concurrent or previous opioid and/or midazolam administration (72 h interval required) 2. Known genetic or chromosomal anomaly 3. Probable rapid extubation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Burlo Garofolo Trieste

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of already described polymorphisms To identify candidate polymorphisms based on the literature explaining interindividual variability in the pharmacokinetics and pharmacodynamics of fentanyl. 1 cc of blood sample will be collected Within 6 hours of fentanyl administration
Primary Identification of new polymorphisms To identify new polymorphisms explaining interindividual variability in the pharmacokinetics and pharmacodynamics of fentanyl. 1 cc of blood sample will be collected. Within 6 hours of fentanyl administration
Secondary To evaluate the statistical association between the polymorphisms identified and fentanyl dosage (µg/kg/hour) Association study. The univariate statistical analysis will consider the dose of fentanyl (µg/kg/hour) as a continuous dependent variable, associating it with the candidate genotypes (independent variables) by means of t-tests. The association of fentanyl dose with genotypes will also be evaluated in a multivariate model, adjusted for relevant demographic and clinical covariates, using generalized linear models. Through study completion, an average of 18 months
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