Analgesic Regimens for Surgical Pain
(CARES for Kids Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates which pain relief method works best after surgeries such as tonsil removal, gallbladder removal, or knee scopes. It compares two groups: one taking NSAIDs (a type of pain reliever) with acetaminophen, and the other taking the same medications plus a low dose of opioids (a class of strong pain relievers). The study aims to determine which option provides better results with fewer side effects. It suits individuals who have undergone one of the mentioned surgeries and do not regularly use pain medication. As a Phase 4 trial, this research involves treatments that are already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you have no significant pain medication use before surgery. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.
What is the safety track record for these treatments?
Past studies have shown that using acetaminophen with NSAIDs effectively relieves pain. Research indicates that combining these two can reduce the need for stronger painkillers like opioids while still providing effective pain control. This combination is well-tolerated with few side effects.
Studies have demonstrated that combining acetaminophen, NSAIDs, and opioids offers strong pain relief. However, opioids can cause more side effects than using just NSAIDs and acetaminophen, such as drowsiness or nausea. Despite this, the combination still shows promise for effective pain management.
Both treatment options have been studied for safety and are generally considered safe when used as directed. Following the doctor's instructions is important to minimize any potential risks.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these analgesic regimens for surgical pain because they explore combinations of acetaminophen, NSAIDs, and opioids in innovative ways. Unlike traditional methods that may rely heavily on opioids alone, these regimens aim to optimize pain relief while potentially reducing opioid dependency and associated side effects. The combination of acetaminophen and NSAIDs offers a multi-modal approach that targets different pain pathways, potentially enhancing pain control and recovery time. By integrating opioids more strategically, these regimens have the potential to deliver effective pain management with a lower risk of opioid-related complications.
What evidence suggests that this trial's treatments could be effective for surgical pain?
Research has shown that taking acetaminophen and NSAIDs (non-steroidal anti-inflammatory drugs) together can effectively reduce pain. This combination often proves more effective than taking each drug alone, particularly for post-surgical pain, such as after dental work. In this trial, one group of participants will receive an acetaminophen/NSAID regimen. Some studies suggest that combining acetaminophen with NSAIDs might reduce the need for opioids, which are strong painkillers with more side effects. Another group in this trial will receive an acetaminophen/NSAID/opioid regimen, as adding small amounts of opioids to acetaminophen and NSAIDs may provide even better pain relief for some people, especially after surgery. Both combinations effectively manage surgical pain, but the best choice depends on balancing pain relief with side effects.26789
Who Is on the Research Team?
Mark Bicket, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for kids who've had tonsillectomies, gallbladder removals, or knee scopes. They'll be randomly assigned to one of two pain management groups after surgery: NSAIDs with acetaminophen or a low dose opioid combined with NSAIDs and acetaminophen.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery and are randomized to receive either NSAIDs plus acetaminophen or low dose opioids with NSAIDs plus acetaminophen for pain management
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain intensity and adverse medication-related symptoms
Long-term monitoring
Participants are assessed for long-term outcomes such as chronic pain, opioid misuse, and healthcare utilization
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen
- Ibuprofen
- NSAID
- Opioid
Acetaminophen is already approved in United States, European Union, Canada for the following indications:
- Pain relief
- Fever reduction
- Pain relief
- Fever reduction
- Pain relief
- Fever reduction
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator