Metabolites in Exhaled Air
Zusammenfassung der Studie
The aim of the study is to investigate metabolites in exhaled air during the administration of a painkiller. Measuring metabolites in exhaled air is a new method to study the intake and effect of medications, with the scientific benefit being the ability to determine the individual absorption and metabolism of drugs. The painkiller used in this study is approved in Switzerland by Swissmedic. The study consists of two appointments of 60 minutes each, spaced at least 24 hours apart, taking place at the University Children's Hospital of Basel, UKBB, Spitalstrasse 33, 4056 Basel. A total of 20 participants will be included in the study. Due to the study design, we cannot inform you about all aspects of the procedure before the study begins. However, you will receive this information after the study is completed and no later than 6 months.
(BASEC)
Untersuchte Intervention
The study consists of two appointments at least 24 hours apart at UKBB, each lasting one hour. At both appointments, you will exhale into a machine, and we will perform the so-called 'Cold Pressure Test' once per appointment. In the 'Cold Pressure Test', we measure how long you can keep your hand in cold water, with the knowledge that at one of the two appointments, you will receive a pain-relieving medication before the test. At the other appointment, the measurement will take place without pain-relieving medication. The order of the two appointments is random. Additionally, we will measure your blood pressure and pulse.
(BASEC)
Untersuchte Krankheit(en)
Exhaled air contains valuable biochemical information at the metabolic level. The aim of this study is to further explore the potential of breath analysis as a non-invasive method to support clinical decision-making. In this study, we investigate metabolites that occur in the breath as a result of taking a painkiller. Metabolites are intermediate products formed during the metabolism of substances.
(BASEC)
• Healthy adult male and female participants • German-speaking or very good knowledge of German • Ability to understand the study and its results • Ability to provide informed consent for participation in the study (BASEC)
Ausschlusskriterien
• Regular intake of medications that may impair pain perception (analgesics, antihistamines, and calcium and potassium channel blockers) • Pregnant • Smoker • Neuropathy • Chronic pain • Neuromuscular or psychiatric disorders • Known or suspected heart, kidney, or liver disease • High blood pressure • History of Raynaud's phenomenon • History of fainting or seizures • History of frostbite • Current medication intake (psychoactive medications, narcotics, intake of analgesics) or psychological and psychiatric treatment (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Universitäts-Kinderspital beider Basel (UKBB),
+41 61 704 14 11;+41 61 704 14 11
melina.richard@clutterukbb.ch(ICTRP)
Wissenschaftliche Auskünfte
Universitäts-Kinderspital beider Basel (UKBB),
+41 61 704 14 11;+41 61 704 14 11
melina.richard@clutterukbb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
07.07.2021
(BASEC)
ICTRP Studien-ID
NCT04956718 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Breath Metabolomics of Placebo Effects Via Cold Pressor Test (ICTRP)
Öffentlicher Titel
Breath Metabolomics of Placebo Effects, a Pilot Study (ICTRP)
Untersuchte Krankheit(en)
Analgesia (ICTRP)
Untersuchte Intervention
Other: Cold Pressor Test (CPT);Other: Placebo NaCl Nasal spray (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Healthy female and male adult volunteers
- German speaking, or good knowledge of the German language
- Able to understand the study
- Able to give informed consent
Exclusion criteria:
- Regularly taking medication potentially interfering with pain sensation (analgesics,
antihistamines and calcium and potassium channel blockers)
- Current pregnancy
- Daily smokers (as per WHO definition: A daily smoker is someone who smokes any tobacco
product at least once a day.)
- Neuropathy
- Chronic pain
- Neuromuscular or psychiatric disease
- Known or suspected heart, kidney or liver disease
- Hypertension (Systolic (mmHg) >130, Diastolic (mmHg) >80)
- History of fainting or seizures
- History of Frostbite
- Current medications (psychoactive medication, narcotics, intake of analgesics) or
being currently in psychological or psychiatric treatment.
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites (ICTRP)
nicht verfügbar
Registrierungsdatum
30.06.2021 (ICTRP)
Einschluss des ersten Teilnehmers
21.10.2021 (ICTRP)
Sekundäre Sponsoren
Swiss National Science Foundation (ICTRP)
Weitere Kontakte
Pablo Sinues, Prof. Dr.;Mélina Richard;Mélina D. Richard, melina.richard@ukbb.ch, +41 61 704 14 11;+41 61 704 14 11, Universitäts-Kinderspital beider Basel (UKBB), (ICTRP)
Sekundäre IDs
2021-01132, ks21Sinues (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT04956718 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar