drugset / Trial / NCT00848419

A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model

NCT00848419

Phase 3 Withdrawn Hadassah Medical Organization
RandomizedParallel-groupTriple-blindTreatment

Summary

The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the analgesic and side effect profiles of epidural methadone, fentanyl and morphine. The investigators will compare the analgesic effect at three dermatomes to assess the rostral spread of drug, the investigators will assess plasma levels to assess the systemic redistribution of drug and the investigators will assess surrogate markers of central opiate effects (nasal capnography and pupilometry). The investigators hypothesize that due to the long-duration of action of methadone, and its intermediate lipophilicity, that methadone will provide a predominantly segmental analgesia of long duration of action, with low rostral spread and low direct central depressant effects (including respiratory depression).

Timeline

Start
2009-04
Primary completion
2009-12
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 200 ug Other
Comparator Methadone Other / unclassified 4 mg Other
Comparator Morphine Other / unclassified 4 mg Other

Indications

No indication recorded.