Opioid induced respiratory depression
Conditions
Interventions
Healthy volunteers will be administered Tapentadol in two doses, oxycodone or placebo. Hypercapnic ventilatory response curves will be obtained as well as pain pressure tests
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Age of 18 to 45 years (inclusive); Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) body weight between 50 kg and 100 kg (inclusive); Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff; Subject is willing to comply with study restrictions
Exclusion criteria
Exclusion criteria: Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator); A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening; History of alcoholism or substance abuse within three years prior to screening; Positive pregnancy test; Positive drug screening or alcohol breath test; Subjects using more than 21 units of alcohol per week; Use of medication during the study period; If sexually active, the subject is not using contraceptives, or surgically sterilized; Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; Participation in an investigational drug trial in the 2 months prior to administration of the initial dose of study drug or more than 5 times per year; Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| repsiratory depression | — |
Secondary
| Measure | Time frame |
|---|---|
| pain pressure treshold | — |
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600
Outcome results
None listed