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Relieving Acute Pain From Rib Fractures

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ClinicalTrials.gov Identifier: NCT03426137
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Luana Colloca, University of Maryland

Brief Summary:

The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain (Nahin 2015). Doctors in the US still prescribe opioids across the board for pain despite a growing recognition of an epidemic of opioid overdose and use disorder. Few solutions have been successfully proposed and implemented. Placebos represent a novel and potentially fruitful means of addressing this issue. However, clinicians often use placebos deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Recently, we reviewed a database of placebo studies including 22 studies in both animals and humans hinting of evidence that placebos may work as a dose extender of active painkillers. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms.

Here, we will test if dose-extending placebos are effective in relieving clinical acute pain in opioid patients with rib fractures. Patients will be randomized to three arms. Arm 1 will be a Full Dose (FD) group, which will receive all NSAIDs as described in the Guidelines for NSAID use in Orthopedic Patients and Oxycodone (10mg). Arm 2 will be a Partial Reinforcement (PR) group, which will receive NSAIDs, Oxycodone (10mg), and placebos to reach a 50% reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group receiving NSAIDs and placebos. Patients will be assigned to one of three arms according to a 1:1:1 schedule of randomization. Study IDs will be generated by the pharmacy and blinding will occur by ensuring that oxycodone and placebos look, smell, and taste identical. Rescue therapy will be provided as needed. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated.


Condition or disease Intervention/treatment Phase
Rib Fractures Opioid Use Opioid-Related Disorders Drug: Oxycodone Drug: Ketorolac Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to three arms. Arm 1 will be a Full Dose (FD) group, which will receive all NSAIDs will be dosed in accordance with the STC Guidelines for NSAID use and Oxycodone (10mg). Arm 2 will be a Partial Reinforcement (PR) group, which will receive NSAIDs, Oxycodone (10mg), and placebo pills to reach a 50% reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group receiving NSAIDs and placebos.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Oxycodone and Placebo will be identical in terms of appearance, taste, and smell so as to keep the investigators, care providers, and participants blind to their treatment allocation. Oxycodone and placebo oral suspensions will be manufactured and dispensed by the pharmacy at University of Maryland Medical Center. All research personnel, aside from the pharmacists and team members responsible for final review and write-up of the study, will be blinded to participants' treatment groups. For participants in the Partial Reduction group (Arm 2), the pharmacy will dispense the study drug such that participants in Arm 2 will receive four doses of Oxycodone (10 mg) followed by one of four repeating schedules of administration alternating between Oxycodone (10 mg) and placebo.
Primary Purpose: Treatment
Official Title: Relieving Acute Pain From Rib Fractures: A Pilot Study
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Full Dose (FD)
Participants in the FD arm will receive NSAIDs and Oxycodone (10mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.
Drug: Oxycodone
10 mg Oxycodone in oral solution given every 3 hours
Other Name: Oxycodone Hydrochloride

Drug: Ketorolac
toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
Other Name: Toradol

Placebo Comparator: PR (Partial Reinforcement)
Participants in this group will receive NSAIDs, Oxycodone (10mg), and placebo pills to reach a 50% reduction of the total intake of opioids.
Drug: Oxycodone
10 mg Oxycodone in oral solution given every 3 hours
Other Name: Oxycodone Hydrochloride

Drug: Ketorolac
toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
Other Name: Toradol

Other: Placebo
Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet
Other Name: OraSweet

Placebo Comparator: C (Control)
Participants in this group will receive NSAIDs and placebo pills
Drug: Ketorolac
toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
Other Name: Toradol

Other: Placebo
Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet
Other Name: OraSweet




Primary Outcome Measures :
  1. Pain self-reports [ Time Frame: Day 1-7, Week 2, Months 1, 3 and 6 ]
    Collected on a visual analogue scale, with 0 being "no pain" and 100 being "maximum pain tolerable"


Secondary Outcome Measures :
  1. State and Trait Anxiety Inventory (STAI-Y1, STAI-Y2) [ Time Frame: Day 1-7, Week 2 ]
    State and Trait Anxiety assessment

  2. Beck Depression Inventory (BDI) [ Time Frame: Day 1-7, Week 2 ]
    Depression Anxiety Assessment

  3. Mood/Depression [ Time Frame: Day 1-7, Week 2 ]
    Mood/Depression Assessment

  4. Fear of Pain Questionnaire (FPQ) [ Time Frame: Day 1-7, Week 2 ]
    Assessment of different forms of fear

  5. Adapted Credibility/Expectancy [ Time Frame: Day 1-7, Week 2 ]
    Assessment of credibility about treatment

  6. Pain intensity Enjoyment of life and General activity (PEG) [ Time Frame: Day 1-7, Week 2 ]
    Three item scale for pain and its interference

  7. Pain Catastrophizing Scale (PCS) [ Time Frame: Day 1-7, Week 2 ]
    Assessment of catastrophizing thoughts

  8. Long-term prescriptions and use of opioids over the follow-up period [ Time Frame: Day 1-7, Week 2 ]
    Collected information about participants' long term opioid use in order to evaluate the effectiveness of each Arm's Intervention on reducing the need for opioid prescriptions and the use of opioids.

  9. Pain self-reports - follow-up [ Time Frame: Day 1-7, Week 2 ]
    Collected on a visual analogue scale, with 0 being "no pain" and 100 being "maximum pain tolerable"

  10. Functional pain scores - follow-up [ Time Frame: Day 1-7, Week 2 ]
    The patient's subjective rating of pain and the objective determination of the pain's interference with activities will produce a corresponding score on a scale of 0-5.


Other Outcome Measures:
  1. Requests of rescue intervention [ Time Frame: Day 1-7 ]
    IV Dilaudid will be provided upon request as a rescue medication. The frequency of these requests will be assessed during hospitalization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • Admission to The Shock Trauma Center within 24 hrs of injury
  • One or more rib fractures
  • Plan by primary service to follow the Shock Trauma Guidelines for Acute Pain in Orthopedic Injury
  • Predicted length of stay greater than or equal to 3 days

Exclusion Criteria:

  • Non english speaking
  • Spine or spinal cord injury
  • Traumatic brain injury
  • Pelvic fracture
  • Patient-controlled analgesia
  • Admission Creatinine > 1.4
  • History of chronic kidney disease
  • History of Chronic Pain
  • Opioid or heroin use in the 3 months prior to admission (patient self report)
  • Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, mania, autism) and /or psychiatric condition leading to treatment and/or hospitalization within the last 1 year.
  • Positive toxicology screen for drugs not prescribed during current hospitalization (opiates, Cocaine, methamphetamines, amphetamines, and/or THC)
  • Pregnancy or breast feeding
  • Contraindication to NSAIDs, including high risk of bleeding or known severe coronary artery disease
  • ICU admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426137


Contacts
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Contact: Research Coordinator, MS 410-706-5975 nrscollocalab@umaryland.edu
Contact: Nathaniel R Haycock, MS 410-706-5975 nhaycock@umaryland.edu

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201-1512
Contact: Luana Colloca    301-364-8089    colloca@umaryland.edu   
Contact: Nathaniel Haycock    4107065975    nhaycock@umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
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Principal Investigator: Luana Colloca, MD/PHD/MS University of Maryland Baltimore School of Nursing

Additional Information:
Publications:
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Responsible Party: Luana Colloca, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT03426137     History of Changes
Other Study ID Numbers: HP-00078742
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will only be shared among study team members.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Luana Colloca, University of Maryland:
Oxycodone
Placebo
Expectancy Induced Analgesia
NSAID

Additional relevant MeSH terms:
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Oxycodone
Fractures, Bone
Acute Pain
Opioid-Related Disorders
Rib Fractures
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Thoracic Injuries
Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action