Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial
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 m...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/11/e030623.full |
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| author | Thomas Scalea Luana Colloca Se Eun Lee Meghan Nichole Luhowy Nathaniel Haycock Chika Okusogu Soojin Yim Nandini Raghuraman Robert Goodfellow Robert Scott Murray Patricia Casper Myounghee Lee Yvette Fouche Sarah Murthi |
| author_facet | Thomas Scalea Luana Colloca Se Eun Lee Meghan Nichole Luhowy Nathaniel Haycock Chika Okusogu Soojin Yim Nandini Raghuraman Robert Goodfellow Robert Scott Murray Patricia Casper Myounghee Lee Yvette Fouche Sarah Murthi |
| author_sort | Thomas Scalea |
| collection | DOAJ |
| description | 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).Trial registration number NCT03426137. |
| format | Article |
| id | doaj-art-7d921979edb34bcb8d77e7f733ff7562 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-7d921979edb34bcb8d77e7f733ff75622025-08-20T01:54:15ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-030623Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trialThomas Scalea0Luana Colloca1Se Eun Lee2Meghan Nichole Luhowy3Nathaniel Haycock4Chika Okusogu5Soojin Yim6Nandini Raghuraman7Robert Goodfellow8Robert Scott Murray9Patricia Casper10Myounghee Lee11Yvette Fouche12Sarah Murthi13R Adams Cowley Shock Trauma Center, Baltimore, Maryland, USAdirector of Placebo Beyond Opinions Center, adjunct professor, MPower professor1 Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA2 Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA1 Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA1 Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA1 Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA1 Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA3 R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA3 R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA3 R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA4 Investigational Drug Services, University of Maryland Medical Center, Baltimore, Maryland, USA5 Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, Maryland, USA3 R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USAIntroduction 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).Trial registration number NCT03426137.https://bmjopen.bmj.com/content/9/11/e030623.full |
| spellingShingle | Thomas Scalea Luana Colloca Se Eun Lee Meghan Nichole Luhowy Nathaniel Haycock Chika Okusogu Soojin Yim Nandini Raghuraman Robert Goodfellow Robert Scott Murray Patricia Casper Myounghee Lee Yvette Fouche Sarah Murthi Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial BMJ Open |
| title | Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial |
| title_full | Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial |
| title_fullStr | Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial |
| title_full_unstemmed | Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial |
| title_short | Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial |
| title_sort | relieving acute pain rap study a proof of concept protocol for a randomised double blind placebo controlled trial |
| url | https://bmjopen.bmj.com/content/9/11/e030623.full |
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