Vitamin C for Acute Pain
(Vicamed Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRaoul Daoust, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hopital du Sacre-Coeur de Montreal

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain. The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months. This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development.

Eligibility Criteria

This trial is for adults over 18 who visited the emergency department with acute musculoskeletal pain, like a fracture or sprain, that's lasted less than 48 hours. They should have a pain level of at least 4 out of 10 and be prescribed NSAIDs without opioids. It's not suitable for those who can't safely take vitamin C or acetaminophen.

Inclusion Criteria

Numerical rating scale (NRS) pain intensity at triage of ≥ 4 on a 0-10 scale

I am 18 years old or older.

I was treated in the emergency department for sudden muscle or joint pain within 2 days of it starting.

+2 more

Exclusion Criteria

I am currently taking vitamin C supplements.

Received an opioid prescription at ED discharge

Allergy to milk (lactose in the placebo), vitamin C, acetaminophen or NSAIDs

+6 more

Participant Groups

The study tests if vitamin C can help reduce pain after an ED visit for acute musculoskeletal issues. Participants will either get vitamin C or a placebo twice daily for seven days, along with regular doses of acetaminophen. Naproxen is provided as backup if needed.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Acetaminophen and Vitamin C with Naproxen rescueExperimental Treatment1 Intervention

900 mg vitamin C taken orally twice a day Extended-release acetaminophen 650 mg two pills every eight hours regularly Naproxen 500 mg as a rescue medication

Group II: Acetaminophen and Placebo with Naproxen rescuePlacebo Group1 Intervention

Placebo taken orally twice a day Extended-release acetaminophen 650 mg two pills every eight hours regularly Naproxen 500 mg as a rescue medication

Vitamin C is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vitamin C for: