Observational Study on the Incorporation of Opioids and Their Metabolites Into Hair of Pediatric Patients
NCT ID: NCT05740657
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2022-12-06
2025-02-28
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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KISPI 000
Patients of the group received one or multiple clinically approved opioids, namely; Fentanyl, Remifentanil, Sufentanil, Alfentanil, Oxycodone, Morphine, Nalbuphine, Hydromorphone and Methadon. The drugs were administered in the course of a surgery or for pain management.
Fentanyl
The drugs were administered in the course of a surgery or for pain management.
Interventions
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Fentanyl
The drugs were administered in the course of a surgery or for pain management.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient's age must be within date of birth irrespective of gestational age to completed 13th year of life
* Patients that received single or multiple treatment (either with single doses or continuous infusion) of fentanyl, remifentanil or sufentanil either during surgery or during stay in the pediatric intensive care unit
Exclusion Criteria
* Inability to understand the study procedure due to language or cognitive reasons (applies to legal representatives and elder children)
* Denied or missing informed consent
* Insufficient amount of head hair to obtain hair sample
* Cosmetic hair treatment, like coloring, bleaching and dying
1 Day
13 Years
ALL
No
Sponsors
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University Children's Hospital, Zurich
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Tina Binz
Role: PRINCIPAL_INVESTIGATOR
University Zürich
Florian Zapf, Dr.
Role: PRINCIPAL_INVESTIGATOR
University's Children Hospital
Locations
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University's Children Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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2022-01693
Identifier Type: -
Identifier Source: org_study_id
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