Metoclopramide vs Acetaminophen for Concussion
(IMPACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two common medications, metoclopramide (used for nausea) and acetaminophen (a pain reliever), to determine which better eases symptoms after a mild head injury, such as headaches, dizziness, or trouble concentrating. It targets individuals who recently experienced a concussion and are suffering from pain or other symptoms as a result. Participants should have sustained their concussion within the last week and be experiencing significant pain or post-concussion symptoms not present before the injury. The trial aims to improve concussion treatment in the emergency department by identifying the more effective medication. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they can benefit more patients.
What is the safety track record for these treatments?
Research has shown that both metoclopramide and acetaminophen are generally well-tolerated. Studies have found that metoclopramide, often used in emergencies, is safe for short-term use and can help manage symptoms like nausea and headaches after a concussion.
Acetaminophen is widely recognized as a safe and effective treatment for headaches, including those from concussions. It is often recommended for relieving post-concussion symptoms such as pain and discomfort.
No major side effects have been commonly reported for either medication in these situations. However, some individuals might experience side effects like drowsiness or mild stomach issues. Participants should discuss any concerns with their healthcare provider before joining a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using metoclopramide and acetaminophen for treating concussions because they offer new ways to manage symptoms. Metoclopramide is typically used for nausea and migraines, and it might help with concussion symptoms by improving blood flow in the brain and reducing headache-related nausea. Acetaminophen is a pain reliever, and while it's commonly used, administering it intravenously can provide faster relief for concussion-related headaches compared to oral options. These treatments are being explored for their potential to provide quicker and more effective symptom relief than standard pain medications like NSAIDs.
What evidence suggests that this trial's treatments could be effective for post-concussion symptoms?
This trial will compare Metoclopramide and Acetaminophen for treating concussion symptoms. Studies have shown that Metoclopramide can reduce headache pain in individuals with post-head injury headaches. Specifically, one study found that patients who took Metoclopramide experienced significant improvement compared to those who took a placebo, which contains no active medicine. Acetaminophen, a common pain reliever, can also aid in faster recovery from concussions. Research suggests that over-the-counter pain relievers like Acetaminophen help individuals resume normal activities sooner after a concussion. Both treatments have evidence supporting their effectiveness in managing post-concussion symptoms.678910
Who Is on the Research Team?
Benjamin W Friedman, MD,MS
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
This trial is for adults who come to the emergency room within 7 days of a mild head injury and are experiencing new, significant post-concussion symptoms like headache or dizziness. They must have moderate-to-severe pain and their doctor plans to give them medication through an IV.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intravenous metoclopramide or acetaminophen for acute post-concussion symptoms
Follow-up
Participants are monitored for changes in post-concussion symptoms using the RPQ and NRS pain score
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen
- Metoclopramide
Trial Overview
The study compares two IV medications—metoclopramide (10mg) versus acetaminophen—to see which works better at relieving acute concussion symptoms such as headache, nausea, and trouble concentrating in the first week after injury. Participants are randomly assigned to one treatment group.
How Is the Trial Designed?
2
Treatment groups
Active Control
Metoclopramide 10 mg IV over 15 minutes
1000 Mg IV over 15 minutes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
Citations
1.
reachmd.com
reachmd.com/news/evaluating-the-role-of-over-the-counter-pain-relievers-in-accelerating-concussion-recovery/2471596/Evaluating the Role of Over-the-Counter Pain Relievers in ...
This evidence suggests a 20% increased likelihood of achieving faster overall recovery, with patients being cleared for unrestricted activities ...
Nonsteroidal anti-inflammatory drug use and concussions in ...
This study aims to assess the effects of preinjury NSAID use on concussion incidence, severity, and recovery in young athletes. METHODS Data ...
3.
medicalupdateonline.com
medicalupdateonline.com/2021/04/nausea-drugs-alleviate-post-concussion-headache-pain/Nausea drugs alleviate post-concussion headache pain
The primary outcome was improvement in pain on a 0-10 scale. At one hour post-treatment, the combination treatment reduced average headache ...
5 Concussion Treatment Methods That Are Drug-Free
In this post, you won't find any recommendations to treat concussion symptoms with acetaminophen, Tylenol, or ibuprofen.
Does Analgesic Overuse Contribute to Chronic Post-traumatic ...
Thirty-seven patients (68.5%) had resolution of headaches or improvements to preconcussion headache patterns after discontinuing analgesics; seven (13%) had no ...
TBI Protocol HonorHealth FINAL
Determine improvement in somatic, cognitive, and emotional post-concussion symptoms as measured by the Rivermeade Post-concussion Questionnaire.
Considerations for Athletic Trainers: A Review of Guidance on ...
It also highlighted that providing clinical guidance to health care providers is critical to improving the health and safety of this vulnerable population.
8.
headachejournal.onlinelibrary.wiley.com
headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14236Acute and chronic management of posttraumatic headache in ...
The main outcome measure was improvement of headache. Poor Age range (mean): 13–17 years Hx of migraine: 6% Outcome: 64% of children had full ...
Efficacy and Outcomes of Pharmacological Treatments for ...
Seventy-one percent of patients (n=21) reported headache relief within 1 hour of treatment with M+D, and effectiveness increased to 95% by 2 ...
Concussion: Evaluation and management
Here, we outline how to evaluate and manage concussion, including treatment of the most common symptoms. KEY POINTS. Concussion results from a ...
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