Metabolites in Exhaled Air
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Mélina Richard
+41 61 704 14 11
melina.richard@clutterukbb.ch(BASEC)
Informazioni generali
Universitäts-Kinderspital beider Basel (UKBB),
+41 61 704 14 11;+41 61 704 14 11
melina.richard@clutterukbb.ch(ICTRP)
Informazioni scientifiche
Universitäts-Kinderspital beider Basel (UKBB),
+41 61 704 14 11;+41 61 704 14 11
melina.richard@clutterukbb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
07.07.2021
(BASEC)
ID di studio ICTRP
NCT04956718 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Breath Metabolomics of Placebo Effects Via Cold Pressor Test (ICTRP)
Titolo pubblico
Breath Metabolomics of Placebo Effects, a Pilot Study (ICTRP)
Malattie studiate
Analgesia (ICTRP)
Intervento studiato
Other: Cold Pressor Test (CPT);Other: Placebo NaCl Nasal spray (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites (ICTRP)
non disponibile
Data di registrazione
30.06.2021 (ICTRP)
Inclusione del primo partecipante
21.10.2021 (ICTRP)
Sponsor secondari
Swiss National Science Foundation (ICTRP)
Contatti aggiuntivi
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)
ID secondari
2021-01132, ks21Sinues (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT04956718 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile