Determination of Analgesic Equipotent Doses of Inhaled Metoxyflurane vs. Intravenous Fentanyl

• Status: Completed
• Trial end date: 2019-10-29
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determinate the equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Analgesics; Fentanyl; Methoxyflurane

Criteria

Inclusion Criteria:

1. Healthy volunteers

2. Age 18 - 64

3. Both sex

4. No chronic disease

5. No regular medication

6. Recruited from the general population

7. Signed informed consent and expected cooperation of the subjects for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations

Exclusion Criteria:

1. Use of pain medication the last 2 days before a session

2. Use of complementary medicine the last 2 days before a session

3. Use of regular medication

4. Previous substance abuse

5. Pregnancy

6. Know allergies or serious side effects to opioids or metoxyflurane

7. Use of alcohol last 24 h before each session

8. Exclusion criteria with respect to fentanyl:

9. Hypersensitivity opposite the active substance (fentanyl) or other opioids

10. Hypersensitivity opposite the excipients (to fentanyl): sodiumclorid, water for injection, hydrochloric acid or sodium hydroxide

11. Respiratory depression without artificial ventilation

12. Use of MAO-inhibitor or use of MAO-inhibitor by two weeks before inclusion

13. Elevated intracranial pressure or brain trauma

14. Hypovolemia or hypotension

15. Myasthenia gravis

16. Exclusion criteria with respect to metoxyflurane:

17. Use metoxyflurane as anesthetic

18. Hypersensitivity opposite metoxyflurane or fluorinated anesthetics

19. Hypersensitivity opposite the excipient (to metoxyflurane):

Butylhydroksytoulen

20. Malignant hyperthermia or persons with suspect genetic predisposition for malignant hyperthermia

21. History (to the volunteer or family) of serious adverse effects after administration of inhalation anesthetics

22. Volunteers showing sign of liver damage after use of metoxyflurane or halogenated anesthetics

23. History of liver disease

24. Clinical significant reduced kidney function or history of kidney disease

25. Changed of level of consciousness of any cause, including brain trauma, drugs or alcohol

26. Clinical detected cardiovascular unstability

27. Clinical detected respiratory depression