Quantity of Opioids for Acute Pain and Limit Unused Medication

NCT03953534 | Completed

• 2 other identifiers: 2019-1684PJT-159808
• Study Type: observational
• Target: 2,240
• Locations: 1 country
• Sites: 6

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 2,560 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.

Conditions

Acute Pain

Keywords

Opioids; Acute Pain

Outcome Measures

Primary Outcomes (1)

• Quantity of opioids consumed during the acute pain phase (2 weeks) following ED discharge for each pain condition

  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.

  During 14 days

Secondary Outcomes (12)

• Quantity of opioids prescribed to ED-discharged patients treated for different acute pain conditions

  Baseline

• Quantity of opioids to sufficiently supply a given percentage of patients for each pain condition

  During 14 days

• Quantity of unused opioids

  At day 14

• Quantity of patients that filled (initial or other) opioid prescriptions

  At day 14

• Quantity of patients using of coanalgesics or other substances (alcohol, cannabis…) to manage pain

  During 14 days

Other Outcomes (2)

• Qualitative evaluation of participant's opioids storage and disposal

  At day 14

• Evaluate the participants' perception of opioid analgesia (patient, physician, nurse, and pharmacist) with a likert scale type survey

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Kingston Health Sciences Centre: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Hopital de l'Enfant-Jesus: collaborator

Study Sites (6)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C4, Canada

Location

Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Hôpital régional de Saint-Jérôme

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Related Publications (3)

• Daoust R, Paquet J, Perry JJ, Yan JW, Williamson D, Castonguay V, Lavigne G, Rouleau D, Lessard J, Cournoyer A; OPUM research group. How Does Self-Declared Chronic Pain Compare to Other Definitions? A Prospective Multicenter Study. Pain Res Manag. 2025 Jun 19;2025:5556400. doi: 10.1155/prm/5556400. eCollection 2025.

  PMID: 40575042 DERIVED

• Daoust R, Paquet J, Emond M, Iseppon M, Williamson D, Yan JW, Perry JJ, Huard V, Lavigne G, Lee J, Lessard J, Lang E, Cournoyer A; Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM) group on behalf of the Network of Canadian Emergency Researchers. Opioid prescribing requirements to minimize unused medications after an emergency department visit for acute pain: a prospective cohort study. CMAJ. 2024 Jul 14;196(25):E866-E874. doi: 10.1503/cmaj.231640.

  PMID: 39009368 DERIVED

• Daoust R, Paquet J, Williamson D, Perry JJ, Iseppon M, Castonguay V, Morris J, Cournoyer A. Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study. BMJ Open. 2022 Oct 28;12(10):e062984. doi: 10.1136/bmjopen-2022-062984.

  PMID: 36307159 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul Daoust, MD MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Researcher

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: May 6, 2019
• Primary Completion: April 19, 2023
• Study Completion: June 14, 2023
• Last Updated: March 31, 2026

Record last verified: 2023-09

Locations

CA (6)