Effect of Vitamin C on Pain Reduction After an Emergency Department Visit - Trial NCT06306183
Access comprehensive clinical trial information for NCT06306183 through Pure Global AI's free database. This phase not specified trial is sponsored by Hopital du Sacre-Coeur de Montreal and is currently Not yet recruiting. The study focuses on Pain, Acute. Target enrollment is 546 participants.
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Study Focus
Sponsor & Location
Hopital du Sacre-Coeur de Montreal
Timeline & Enrollment
N/A
Nov 01, 2024
Mar 01, 2028
Primary Outcome
Daily pain intensity
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06306183
Non-Device Trial