Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306183
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-28
Brief Title:
Effect of Vitamin C on Pain Reduction After an Emergency Department Visit
Sponsor:
Hopital du Sacre-Coeur de Montreal
Organization:
Hopital du Sacre-Coeur de Montreal
Study Overview
Official Title:
Does Vitamin C Provide an Analgesic Effect on Acute Musculoskeletal Injury After an Emergency Department Visit A Double-Blind Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vicamed
Brief Summary:
Emergency department ED clinicians often prescribe anti-inflammatory drugs NSAIDs to manage acute musculoskeletal MSK pain eg 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 patients 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
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 patients 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
Detailed Description:
Background and Importance Nonsteroidal anti-inflammatory drugs NSAIDs have proven their efficacy and compared advantageously to opioids in treating acute musculoskeletal MSK pain However even short-term NSAIDs use for acute pain management after an emergency department ED discharge can have significant gastrointestinal cardiovascular musculoskeletal and renal adverse effects Recent evidence has shown that vitamin C has in addition to its antioxidant effect some analgesic and anti-inflammatory properties Its analgesic effect has been explored mostly in short-term postoperative context or in disease-specific chronic pain prevention but never after acute pain from MSK injuries which are often seen in EDs
Goals Research Aims The primary aim is to evaluate the effectiveness of vitamin C in reducing pain intensity during a seven-day period following ED discharge for an acute MSK pain complaint The secondary aims are to compare both treatment groups for rescue medication use average pain relief and adverse events during a seven-day follow-up and at three months for chronic pain incidence
Methods Approaches Expertise The investigators will conduct a pragmatic five-center double-blind randomized placebo-controlled trial RCT with 546 participants equally distributed in two arms one group receiving 900 mg of vitamin C and another one 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 will be used as a rescue medication if the patients pain is not relieved more than one hour after acetaminophen consumption Participants will be aged 18 years treated in the emergency department for acute MSK injury present for less than 48 hours with a pain intensity at triage of 4 on a numerical rating scale NRS of 0-10 and scheduled for discharge by an emergency clinician with an NSAIDs prescription without opioids Daily pain intensity during the seven-day period will be assessed via a previously tested electronic or paper diary In addition patients will report their daily rescue pain medication use pain relief and adverse events Three months after the ED visit participants will be contacted to evaluate chronic pain development
The investigators hypothesized that vitamin C will reduce pain intensity during a seven-day follow-up for ED discharged patients treated for acute MSK pain This project brings together a committed multidisciplinary research team composed of five study sites having previously collaborated on large multicenter RCT studies All required instruments have been successfully used during an ongoing Canadian Institutes of Health Research CIHR grant a non-objection letter from Health Canada has been already requested and the investigators have secured a provider for both study drugs all this ensuring a rapid study implementation
Expected Outcomes The investigators will provide the following outcomes for patients receiving vitamin C and placebo pain intensity rescue medication use pain relief and side effects for one-week post-discharge and chronic pain incidence at three months Confirmation of the vitamin C analgesic effect for acute MSK pain could help patients who are unable to consume or are at risk of complications from NSAIDS It may also contribute to the reduction of the burden associated with chronic pain development
Goals Research Aims The primary aim is to evaluate the effectiveness of vitamin C in reducing pain intensity during a seven-day period following ED discharge for an acute MSK pain complaint The secondary aims are to compare both treatment groups for rescue medication use average pain relief and adverse events during a seven-day follow-up and at three months for chronic pain incidence
Methods Approaches Expertise The investigators will conduct a pragmatic five-center double-blind randomized placebo-controlled trial RCT with 546 participants equally distributed in two arms one group receiving 900 mg of vitamin C and another one 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 will be used as a rescue medication if the patients pain is not relieved more than one hour after acetaminophen consumption Participants will be aged 18 years treated in the emergency department for acute MSK injury present for less than 48 hours with a pain intensity at triage of 4 on a numerical rating scale NRS of 0-10 and scheduled for discharge by an emergency clinician with an NSAIDs prescription without opioids Daily pain intensity during the seven-day period will be assessed via a previously tested electronic or paper diary In addition patients will report their daily rescue pain medication use pain relief and adverse events Three months after the ED visit participants will be contacted to evaluate chronic pain development
The investigators hypothesized that vitamin C will reduce pain intensity during a seven-day follow-up for ED discharged patients treated for acute MSK pain This project brings together a committed multidisciplinary research team composed of five study sites having previously collaborated on large multicenter RCT studies All required instruments have been successfully used during an ongoing Canadian Institutes of Health Research CIHR grant a non-objection letter from Health Canada has been already requested and the investigators have secured a provider for both study drugs all this ensuring a rapid study implementation
Expected Outcomes The investigators will provide the following outcomes for patients receiving vitamin C and placebo pain intensity rescue medication use pain relief and side effects for one-week post-discharge and chronic pain incidence at three months Confirmation of the vitamin C analgesic effect for acute MSK pain could help patients who are unable to consume or are at risk of complications from NSAIDS It may also contribute to the reduction of the burden associated with chronic pain development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None