Metabolites in Exhaled Air
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
• 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)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Informations générales
Universitäts-Kinderspital beider Basel (UKBB),
+41 61 704 14 11;+41 61 704 14 11
melina.richard@clutterukbb.ch(ICTRP)
Informations scientifiques
Universitäts-Kinderspital beider Basel (UKBB),
+41 61 704 14 11;+41 61 704 14 11
melina.richard@clutterukbb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
07.07.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT04956718 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
Breath Metabolomics of Placebo Effects Via Cold Pressor Test (ICTRP)
Titre public
Breath Metabolomics of Placebo Effects, a Pilot Study (ICTRP)
Maladie en cours d'investigation
Analgesia (ICTRP)
Intervention étudiée
Other: Cold Pressor Test (CPT);Other: Placebo NaCl Nasal spray (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites (ICTRP)
non disponible
Date d'enregistrement
30.06.2021 (ICTRP)
Inclusion du premier participant
21.10.2021 (ICTRP)
Sponsors secondaires
Swiss National Science Foundation (ICTRP)
Contacts supplémentaires
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 secondaires
2021-01132, ks21Sinues (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/show/NCT04956718 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible