Trauma Clinical Trial
Official title:
Determination of Analgesic Equipotent Doses of Inhaled Metoxyflurane vs. Intravenous Fentanyl Using Cold Pressor Test (CPT) in Volunteers: A Randomized, Double Blind, Placebo-controlled Crossover Study.
Verified date | November 2019 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determinate the equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 29, 2019 |
Est. primary completion date | October 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Harald Lenz | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Albrecht E, Taffe P, Yersin B, Schoettker P, Decosterd I, Hugli O. Undertreatment of acute pain (oligoanalgesia) and medical practice variation in prehospital analgesia of adult trauma patients: a 10 yr retrospective study. Br J Anaesth. 2013 Jan;110(1):9 — View Citation
Clark RB, Beard AG, Thompson DS. Renal function in newborns and mothers exposed to methoxyflurane analgesia for labor and delivery. Anesthesiology. 1979 Nov;51(5):464-6. — View Citation
Grindlay J, Babl FE. Review article: Efficacy and safety of methoxyflurane analgesia in the emergency department and prehospital setting. Emerg Med Australas. 2009 Feb;21(1):4-11. doi: 10.1111/j.1742-6723.2009.01153.x. Review. — View Citation
Mazze RI. Methoxyflurane revisited: tale of an anesthetic from cradle to grave. Anesthesiology. 2006 Oct;105(4):843-6. — View Citation
Neighbor ML, Honner S, Kohn MA. Factors affecting emergency department opioid administration to severely injured patients. Acad Emerg Med. 2004 Dec;11(12):1290-6. — View Citation
Rosen M, Latto P, Asscher AW. Kidney function after methoxyflurane analgesia during labour. Br Med J. 1972 Jan 8;1(5792):81-3. — View Citation
Stephen CR. Clinical applications of methoxyflurane. Acta Anaesthesiol Scand Suppl. 1966;24:215-22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NRS (numeric rating scale) scores during the second CPT, which starts 5 minutes after drug administration and lasts for 90 seconds. NRS is a scale from 0 to 10 (0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10). 0 = no pain and 10 = worst pain imaginable. | NRS (numeric rating scale) scores during CPT (Cold pressor test) 5 minutes after drug administration. The CPT lasts for 90 seconds. The endpoints are NRS scores every 10. second during the CPT. | 90 seconds | |
Secondary | NRS (numeric rating scale) scores during the second CPT, which starts 20 minutes after drug administration and lasts for 90 seconds. This is a scale from 0 to 10 (0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10). 0 = no pain and 10 = worst pain imaginable. | NRS scores during CPT (Cold pressor test) 20 minutes after drug administration (15 minutes after last CPT).The CPT lasts for 90 seconds. The endpoints are NRS scores every 10. second during the CPT. | 90 seconds |
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