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    Relieving acute pain (RAP) study: A proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial

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    Author
    Colloca, L.
    Lee, S.E.
    Luhowy, M.N.
    Haycock, N.
    Okusogu, C.
    Yim, S.
    Raghuraman, N.
    Goodfellow, R.
    Murray, R.S.
    Casper, P.
    Lee, M.
    Scalea, T.
    Fouche, Y.
    Murthi, S.
    Show allShow less

    Date
    2019
    Journal
    BMJ Open
    Publisher
    BMJ Publishing Group
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1136/bmjopen-2019-030623
    Abstract
    Introduction Physicians and other prescribing clinicians use opioids as the primary method of pain management after traumatic injury, despite growing recognition of the major risks associated with usage for chronic pain. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. This study hypothesises that dose-extending placebos can be an effective treatment in relieving clinical acute pain in trauma patients who take opioids. Methods and analysis The relieving acute pain is a proof-of-concept randomised, placebo-controlled, double-blinded, single-site study enrolling 159 participants aged from 18 to 65 years with one or more traumatic injuries treated with opioids. Participants will be randomly assigned to three different arms. Arm 1 will receive the full dose of opioids with non-steroidal anti-inflammatory drugs (NSAIDs). Arm 2 will receive the 50% overall reduction in opioid dosage, dose-extending placebos and NSAIDs. Arm 3 (control) will receive NSAIDs and placebos. The trial length will be 3 days of hospitalisation (phase I) and 2-week, 1-month, 3-month and 6-month follow-ups (exploratory phase II). Primary and secondary outcomes include feasibility and acceptability of the study. Pain intensity, functional pain, emotional distress, rates of rescue therapy requests and patient-initiated medication denials will be collected. Ethics and dissemination All activities associated with this protocol are conducted in full compliance with the Institutional Review Board policies and federal regulations. Publishing this study protocol will enable researchers and funding bodies to stay up to date in their fields by providing exposure to research activity that may not otherwise be widely publicised. Date and protocol version identifier 3/6/2019 (HP-00078742). Copyright 2019 Author(s).
    Sponsors
    This work was funded by the Agency for Healthcare Research and Quality (R24HS022135), MPowering the State: Strategic Partnership Grant (LC) to conduct clinical research related to new approaches to taper opioids for the management of acute pain.%blankline%
    Keyword
    dose-extending placebo
    emotional distress
    functional pain
    opioid
    pain interference
    pharmacological conditioning
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85074906177&doi=10.1136%2fbmjopen-2019-030623&partnerID=40&md5=4c08a24950f18b37c21bb9bd74fb1d0b; http://hdl.handle.net/10713/11440
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2019-030623
    Scopus Count
    Collections
    UMB Open Access Articles 2019

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