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

ConditionPain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Opioid use 1 month prior to the ED visit;

Already taking vitamin C supplement;

Active cancer;

Treated for chronic pain;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Placebo

    Other intervention

    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

Treatment groups

464 Participants
are divided into 2 treatment groups
Group A: Vitamin CExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
14 days

Secondary outcomes

1

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.

Time frame
14 days
2

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).

Time frame
14 days
3

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.

Time frame
14 days
4

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

Time frame
14 days

Other outcomes

Sponsors and contacts

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