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Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM)

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ClinicalTrials.gov Identifier: NCT03953534
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Kingston Health Sciences Centre
Maisonneuve-Rosemont Hospital
Sunnybrook Health Sciences Centre
Hopital de l'Enfant-Jesus
Information provided by (Responsible Party):
Raoul Daoust, Hopital du Sacre-Coeur de Montreal

Brief Summary:

Opioids (morphine and morphine-like substances) are often prescribed to patients to manage pain after an emergency department visit. In the past 20 years, opioid prescriptions have risen sharply, accompanied by a significant rise in opioid misuse (e.g., recreational or non-medical use, potentially leading to addiction or overdose). One explanation for this crisis is the availability and easy access of leftover opioid pills in Canadian homes, allowing family members (including children) and friends to take them for reasons other than pain relief.

Canada has no recommendations for the dosage, duration, or quantity of opioids that physicians should prescribe to manage acute pain at home. Physicians are therefore left guessing as to how much to prescribe when a patient with a condition like a fracture or renal colic is discharged from the emergency department. Our preliminary study showed that two-thirds of the pills from the initial opioid prescription to treat acute pain actually remained unused and were therefore available for potential misuse.

The investigators propose to determine how many opioid pills are consumed by patients who suffer from acute pain as they recover at home. The investigators will ask 2,580 patients (from 6 Canadian hospitals) to record their pain medication consumption in a 14-day diary. The investigators will also determine, their pain intensity level, whether or not they had new opioid prescriptions, and health services revisits. In case of missing information, patients will be contacted by phone at 2 weeks. The overall aim is to help emergency department physicians prescribe the right number of pills in order to manage patients' pain and at the same time reduce substantially leftovers available for potential misuse.


Condition or disease
Acute Pain

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2580 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM Study)
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2022



Primary Outcome Measures :
  1. Quantity of opioids consumed during the acute pain phase (2 weeks) following ED discharge for each pain condition [ Time Frame: During 14 days ]
    This will allow us to define the quantity of opioids needed to manage acute pain while limiting the quantity of unused pills available for potential misuse.


Secondary Outcome Measures :
  1. Quantity of opioids prescribed to ED-discharged patients treated for different acute pain conditions [ Time Frame: Baseline ]
    From physicians' prescriptions

  2. Quantity of opioids to sufficiently supply a given percentage of patients for each pain condition [ Time Frame: During 14 days ]
    Patient's questionnaire after 2 weeks and 14-diary on opioids consumption.

  3. Quantity of unused opioids [ Time Frame: At day 14 ]
    Patient's questionnaire after 2 weeks

  4. Quantity of patients that filled (initial or other) opioid prescriptions [ Time Frame: At day 14 ]
    Patient's questionnaire after 2 weeks

  5. Quantity of patients using of coanalgesics or other substances (alcohol, cannabis…) to manage pain [ Time Frame: During 14 days ]
    Patient's questionnaire after 2 weeks

  6. Qualitative evaluation of the participants' reasons for stopping opioid consumption [ Time Frame: During 14 days ]
    Patient's questionnaire after 2 weeks

  7. Incidence and type of medication side effects during the 2-week period [ Time Frame: During 14 days ]
    Patient's questionnaire after 2 weeks

  8. Quantity of patients who revisit health services to obtain new prescription [ Time Frame: During 14 days ]
    Patient's questionnaire after 2 weeks

  9. Quantitive validation of the patients' self-report opioid consumption [ Time Frame: At day 14 ]
    Comparison of self-report comsumption and in person pill count after 2 weeks

  10. Group-based trajectory modeling to determine pain intensity trajectory for each pain condition during the acute phase [ Time Frame: During 14 days ]

    After 2 weeks. Average pain intensity for each patient will be measured using a 0-10 numerical rating scale for each of the 14-day diary.

    Group-based trajectory modeling will then be used to identify groups of patients with similar pattern of pain evolution over time without assuming the existence of a specific trend or number of groups.


  11. Evaluate the chronic pain prevalence at 3 months among study participants assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later. [ Time Frame: 3 months ]
    After 90 days. Chronic pain will be defined as a pain intensity score at 3-month of >=4 and with moderate or severe functional disability using the pain disability index score (>40).

  12. Assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later [ Time Frame: 3 months ]

    Pain intensity trajectories after 14 days and chronic pain at 3 months. Average pain intensity for each patient will be measured using a 0-10 numerical rating scale for each of the 14-day diary.

    Group-based trajectory modeling will then be used to identify groups of patients with similar pattern of pain evolution over time without assuming the existence of a specific trend or number of groups.

    Chronic pain will be defined as a pain intensity score at 3-month of >=4 and with moderate or severe functional disability using the pain disability index score (>40).



Other Outcome Measures:
  1. Qualitative evaluation of participant's opioids storage and disposal [ Time Frame: At day 14 ]
    Patient's questionnaire after 2 weeks

  2. Evaluate the participants' perception of opioid analgesia (patient, physician, nurse, and pharmacist) with a likert scale type survey [ Time Frame: Baseline ]
    Survey with Likert style questions administered before start of recruitment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

The patient's sex/gender may have an incidence on the quantity of opioids consumed. We will also look if there are sex/gender differences in the quantity of opioids prescribed and unused, in pain trajectory, in reasons for stopping opioids, and access to the health care system.

The patient gender will be self-reported in the electronic diary (or paper version) using the following multiple choice question.

To which gender identity do the participant most identify?

  • Female
  • Male
  • Transgender Female
  • Transgender Male
  • Other
  • Prefer Not to Answer
Sampling Method:   Non-Probability Sample
Study Population

A cohort of consecutive ED patients aged 18 years or more, treated for an acute pain condition present for less than 2 weeks (usual acute pain definition),and discharged with an opioid prescription will be included.

In accordance to our pragmatic approach, we will exclude only patients with current use of opioids or chronic pain medication for a pre-existing condition or disease (e.g., cancer), because opioid dosage and/or pain mechanisms differ in these circumstances.

Criteria

Inclusion Criteria:

  • Opioid prescription at discharge
  • Acute pain for less than 2 weeks

Exclusion Criteria:

  • Language barrier
  • Chronic pain under treatment
  • Active Neoplasia
  • Follow-up impossible / Unable to complete agenda
  • Already on opioids

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): NCT03953534


Contacts
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Contact: Martin Marquis, MSc 514-338-2222 ext 7584 martin.marquis.cnmtl@ssss.gouv.qc.ca

Locations
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Canada, Ontario
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hôpital Maisonneuve-Rosemont Not yet recruiting
Montréal, Quebec, Canada, H1T 2M4
Hôpital du Sacré-Coeur de Montréal Recruiting
Montréal, Quebec, Canada, H4J 1C4
Hôpital régional de Saint-Jérôme Not yet recruiting
Saint-Jérôme, Quebec, Canada, J7Z 5T3
Canada
Hôpital de l'Enfant-Jésus Not yet recruiting
Québec, Canada, G1J 1Z4
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Kingston Health Sciences Centre
Maisonneuve-Rosemont Hospital
Sunnybrook Health Sciences Centre
Hopital de l'Enfant-Jesus
Investigators
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Principal Investigator: Raoul Daoust, MD MSc Université de Montréal

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Responsible Party: Raoul Daoust, Clinician Researcher, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT03953534     History of Changes
Other Study ID Numbers: 2019-1684
PJT-159808 ( Other Grant/Funding Number: CIHR )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Raoul Daoust, Hopital du Sacre-Coeur de Montreal:
Opioids
Acute Pain

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents