A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation
Sedation is a common side effect of opioid analgesics. In patients where this remains a dose
limiting toxicity, stimulants (caffeine, methylphenidate, ephedrine, amphetamine) have been
the primary class of agents used to counteract sedation. Modafinil is a novel stimulant
that is FDA approved for the treatment of narcolepsy and has a very different side effect
profile than traditional stimulants. The potential role of this agent in the treatment of
opioid induced sedation remains undefined. This study, which utilizes a prospective,
randomized, blinded, cross-over design, will collect daily information on sedation (Epsworth
Sleepiness Scale), pain, opioid consumption, and adverse effects in 90 patients suffering
from opioid induced sedation within the Johns Hopkins Medical Institutions.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Sedation
Stuart A Grossman, MD
Principal Investigator
Johns Hopkins University
United States: Institutional Review Board
J0502
NCT00267332
January 2006
December 2006
Name | Location |
---|---|
The Johns Hopkins Hospital | Baltimore, Maryland 21205 |