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Observational Study on the Incorporation of Opioids and Their Metabolites Into Hair of Pediatric Patients

NCT05740657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-03-30

No results posted yet for this study

Summary

Hair analysis is a well-established and important tool in both forensic and clinical context. When it comes to the interpretation of positive hair analysis results, reliable and comprehensive reference data is essential. Such data on opioids, especially novel synthetic ones (such as fentanyl and its analogues (fentalogs)) is currently highly limited. This applies especially to hair with pediatric origin, due to differences in the metabolism and hair anatomy in children compared to adults.

Investigators hypothesize that opioids, both traditional and novel synthetic ones exhibit detectable concentrations and distinct metabolite ratios within the hair matrices of pediatric patients. Thus, this observational, prospective research study provides 150 hair and sweat samples from children who received opioids as part of surgery or pain management. The samples will be consecutively extracted and analyzed using a sensitive targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, enabling the quantitative determination of the opioid and metabolite concentrations. The study thereby contributes valuable reference data for both forensic and clinical applications, addressing challenges in interpreting hair analysis results in especially pediatric populations. Further, a deeper understanding of the mechanisms (e.g. via sweat) and pharmacokinetic processes involved in the opioid incorporation to hair will be achieved. The study has received ethical approval from the Swiss Ethics Board (approval number: 2022-01693 / amendment approval date: 09.01.2024).

Conditions

  • Opioid Use, Unspecified

Interventions

DRUG

Fentanyl

The drugs were administered in the course of a surgery or for pain management.

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Tina Binz · University Zürich

  • Florian Zapf, Dr. · University's Children Hospital

Eligibility

Min Age
1 Day
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740657 on ClinicalTrials.gov