protocolSection identificationModule nctId: NCT06306183, orgStudyIdInfo id: 2024-2829, briefTitle: Effect of Vitamin C on Pain Reduction After an Emergency Department Visit, acronym: Vicamed, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hopital du Sacre-Coeur de Montreal, class: OTHER, collaborators name: Hopital de l'Enfant-Jesus, collaborators name: The Ottawa Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind randomized placebo-controlled trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 546, type: ESTIMATED, armsInterventionsModule interventions name: Acetaminophen and Vitamin C with Naproxen rescue, interventions name: Acetaminophen and Placebo with Naproxen rescue, outcomesModule primaryOutcomes measure: Daily pain intensity, secondaryOutcomes measure: NSAIDs consumption, secondaryOutcomes measure: Pain relief, secondaryOutcomes measure: New analgesic prescriptions, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Quality of life improvement at seven days, secondaryOutcomes measure: Quantity of Healthcare visits, secondaryOutcomes measure: Prevalence of chronic pain, secondaryOutcomes measure: Prevalence of complex regional pain syndromes for limb fractures, secondaryOutcomes measure: Quality of life improvement at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital du Sacre-Coeur de Montreal, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False