Impact of Vitamin C on opioïd Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain

NCT05555576 | Recruiting

• 1 other identifier: 2023-2442
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Keywords

Vitamin C; Opioids; Emergency department; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain intensity trajectories

  14 days

• Average pain relief

  14 days

• Number (%) of participants with side effects

  14 days

• Total morphine 5 mg equivalent pills consumed for each type of musculoskeletal (MSK) pain

  14 days

• Incidence of chronic pain (including complex regional pain syndrome (CRPS)) globally and for each type of MSK pain

  3 months

Study Arms (2)

Vitamin C

EXPERIMENTAL

1 000 mg vitamin C taken orally twice a day

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Matching placebo

Other: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

1000 mg vitamin C taken orally twice a day (one in the morning and one in the evening) for a 14-day period after ED discharge for the treatment arm

Vitamin C

Placebo OTHER

Placebo taken orally twice a day (one in the morning and one in the evening) for a 14-day period after ED discharge for the treatment arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and over;
• Treated in ED for acute musculoskeletal pain present for less than 2 weeks;
• Discharged with an opioid prescription;
• Speaks French or English.

You may not qualify if:

• Opioid use 1 month prior to the ED visit;
• Already taking vitamin C supplement;
• Active cancer;
• Treated for chronic pain;
• Treated for opioid use disorder;
• Unable to fill out diary or unavailable for follow-up;
• Any allergy, intolerance or sensitivity to milk (lactose) or morphine
• Treated with cyclosporin or coumadin
• 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.)

Sponsors & Collaborators

• Hopital de l'Enfant-Jesus: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C4, Canada

RECRUITING

Related Publications (2)

• Daoust R, Paquet J, Williamson D, Huard V, Arbour C, Perry JJ, Emond M, Berthelot S, Archambault P, Rouleau D, Morris J, Cournoyer A. Impact of vitamin C on the reduction of opioid consumption for acute musculoskeletal pain: A double-blind randomized control pilot study. PLoS One. 2024 Dec 31;19(12):e0316450. doi: 10.1371/journal.pone.0316450. eCollection 2024.

  PMID: 39739762 DERIVED

• Daoust R, Paquet J, Chauny JM, Williamson D, Huard V, Arbour C, Emond M, Rouleau D, Cournoyer A. Impact of vitamin C on the reduction of opioid consumption after an emergency department visit for acute musculoskeletal pain: a double-blind randomised control trial protocol. BMJ Open. 2023 May 24;13(5):e069230. doi: 10.1136/bmjopen-2022-069230.

  PMID: 37225265 DERIVED

MeSH Terms

Conditions

Acute Pain; Emergencies; Pain

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Raoul Daoust, MD MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Marquis, MSc

CONTACT

514-338-2222; martin.marquis.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Emergency Medicine, Professor, Clinician Researcher

Model Details: Double-blind randomized placebo-controlled trial

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 27, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)