Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
NCT Number: NCT06971315
Non-opioid treatments are increasingly sought after for managing acute pain. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., Advil, Motrin, Naproxen) combined with acetaminophen (e.g., Tylenol) have become an alternative for relieving acute pain. However, many patients cannot tolerate or have contraindications to NSAIDs and acetaminophen.
There is therefore an urgent need for studies evaluating the analgesic effects of vitamin C in the context of acute pain. Our study is conducted with healthy volunteer participants receiving either vitamin C or a placebo to assess the analgesic effect of vitamin C by comparing pain detection and tolerance thresholds.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H4J 1C5, Canada
Opioid-free treatments are increasingly sought for acute pain and NSAIDs have become an alternative to treat acute MSK pain and are often administered in addition to acetaminophen. However, NSAIDs can produce important adverse events and are contraindicated in many patients with comorbidities (e.g., heart disease, renal failure). Similarly, acetaminophen is contraindicated in patients with active liver disease or severe hepatic impairment.
Vitamin C has shown opioid sparing and anti-inflammatory effects mostly in postoperative contexts. Vitamin C has also demonstrated very low toxicity and rare contraindications at the dosage used in this study. Demonstrating that vitamin C increases pain detection and tolerance thresholds, thereby exhibiting an analgesic effect, could offer a valuable alternative or adjunct for patients who cannot tolerate or have contraindications to NSAIDs or acetaminophen, helping to reduce opioid use. With an aging population, the number of affected patients is expected to rise significantly.
The primary outcome is the pressure pain detection threshold (PPDT) measured with an algometer one to three hours after the last dose of the study drug (24 hours after the first dose of vitamin C or placebo).
Secondary outcomes are PPDT one to three hours after the first study drug dose, PPTT one to three hours after the initial dose and last dose of the study drug, and adverse events from the algometer or the vitamin C.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three doses of 900 mg vitamin C taken orally (baseline, 12 hours and 24 hours)
Three doses of 900 mg placebo taken orally (baseline, 12 hours and 24 hours)
Time frame: 24 hours
Pressure pain detection threshold (PPDT) measured with an algometer one to three hours after the last dose of the study drug (24 hours after the first dose of vitamin C or placebo).
Time frame: 1 hours
Pressure pain detection threshold (PPDT) measured with an algometer one to three hours after the first dose of the study drug
Time frame: 24 hours
Pressure pain tolerance threshold (PPTT) measured with an algometer one to three hours after the last dose of the study drug
Time frame: 1 hour
Pressure pain tolerance threshold (PPTT) measured with an algometer one to three hours after the first dose of the study drug
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Other
Impact of Vitamin C on Pain Detection and Tolerance Threshold: a Double-blind Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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