Pain, Acute Clinical Trial
Official title:
Impact of Vitamin C on the Reduction of Opioid Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain: A Double-Blind Randomized Control Trial Protocol
Recent evidence has shown that vitamin C has some analgesic properties and can therefore reduce opioids used during healing. Vitamin C analgesic effect has been explored mostly during the short-term postoperative context or in disease specific chronic pain prevention but not after acute musculoskeletal injuries, which are often seen in the emergency department (ED). The study's primary aim is to compare the total morphine 5 mg equivalent pills consumed during a two-week follow-up between patients receiving vitamin C or a placebo after ED discharge for an acute musculoskeletal pain complaint. The investigators will conduct a double-blind randomized placebo-controlled trial with 464 participants distributed in two arms, one group receiving 1 000 mg of vitamin C twice a day for 14 days and another one receiving a placebo. Participants will be ≥18 years of age, treated in ED for acute musculoskeletal pain present for less than 2 weeks, and discharged with an opioid prescription for home pain management. Total morphine 5 mg equivalent pills consumed during the two-week follow-up will be assessed via an electronic (or paper) diary. In addition, patients will report their daily pain intensity, pain relief, side effects, and other types of pain medication or other non-pharmacological approach (ice, heat, immobilization, etc.) used. Three months after the injury, participants will also be contacted to evaluate chronic pain development. The investigators hypothesized that vitamin C, compared to a placebo, will reduce opioid consumption during a 14-day follow-up for ED discharged patients treated for acute pain.
Status | Recruiting |
Enrollment | 464 |
Est. completion date | December 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Aged 18 and over; 2. Treated in ED for acute musculoskeletal pain present for less than 2 weeks; 3. Discharged with an opioid prescription; 4. Speaks French or English. Exclusion Criteria: 1. Opioid use 1 month prior to the ED visit; 2. Already taking vitamin C supplement; 3. Active cancer; 4. Treated for chronic pain; 5. Treated for opioid use disorder; 6. Unable to fill out diary or unavailable for follow-up; 7. Any allergy, intolerance or sensitivity to milk (lactose) or morphine 8. Treated with cyclosporin or coumadin 9. Pregnant or lactating (dosage > 1,800 mg not recommended. For women of child-bearing age and sexually active in the past 3 months, a urine pregnancy test will be performed.) |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital du Sacré-Coeur de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Hopital du Sacre-Coeur de Montreal | Hopital de l'Enfant-Jesus |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in the total morphine 5 mg equivalent pills consumed | Compare the difference in the total morphine 5 mg equivalent pills consumed after a two-week follow-up between patients receiving vitamin C versus patients receiving a placebo during these two weeks. | 14 days | |
Secondary | Pain intensity trajectories | Compare pain intensity trajectories, measured on an 11-point numerical rating scale (NRS) from 0 to 10 (0 is no pain and 10 worst pain imaginable), between both groups with group-based trajectory modelling. | 14 days | |
Secondary | Average pain relief | Patient's average pain relief during the two-week, measured on an 11-point numerical rating scale (NRS) from 0 to 10 (0 is no pain and 10 worst pain imaginable). | 14 days | |
Secondary | Number (%) of participants with side effects | Patients will report which of the following side effects were experienced during the 14-day period: nausea, vomiting, constipation, dizziness, drowsiness, sweating, weakness, or other side effects. | 14 days | |
Secondary | Total morphine 5 mg equivalent pills consumed for each type of musculoskeletal (MSK) pain | Fracture, contusions, cervical pain, lower back pain, MSK pain at other sites | 14 days | |
Secondary | Incidence of chronic pain (including complex regional pain syndrome (CRPS)) globally and for each type of MSK pain | Globally and for each type of MSK pain using pain disability index (PDI) or Budapest criteria | 3 months | |
Secondary | Incidence of CRPS for limb fractures, and for a wrist fracture | For these cases in particular using Budapest criteria | 3 months | |
Secondary | Prevalence of opioid use | Patients will be asked if they still consumed opioids at 3 months | 3 months |
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