Ibuprofen + Acetaminophen for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of different pain relief methods for children after dental surgery. It compares three treatments: ibuprofen alone, a combination of ibuprofen and acetaminophen, and alternating between the two. The focus is on reducing pain and discomfort following the procedure. The trial seeks children who require dental surgery under general anesthesia, have no known allergies to the medications, and whose guardians speak English. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, with the goal of understanding how they benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a history of adverse reactions to NSAIDs or acetaminophen, you cannot participate.
What is the safety track record for these treatments?
Research shows that taking ibuprofen and acetaminophen together can relieve post-surgery pain more effectively than taking either one alone. Studies have found this combination can be as effective, or even better, than some stronger pain medications, like opioids, and it usually has fewer side effects.
When taken together, either by alternating or simultaneously, these two medicines are generally well-tolerated. Many studies found that people experienced fewer unwanted effects compared to other pain relief options. For most people, taking these medicines together is considered safe and effective.
This trial is in a later phase, indicating that earlier tests have already demonstrated the treatment's safety. For those considering joining this trial, existing research suggests the treatment should be well-tolerated.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for postoperative pain because they explore different ways to maximize pain relief while minimizing side effects. Unlike the standard approach of using a single medication like ibuprofen, one treatment arm alternates between ibuprofen and acetaminophen every three hours, potentially providing more consistent pain control. Another approach combines both medications at the same time, aiming for a synergistic effect that could enhance pain relief. These strategies could offer patients more effective pain management options following surgery, potentially improving recovery experiences.
What evidence suggests that this trial's treatments could be effective for postoperative pain in children?
This trial will compare different methods of administering ibuprofen and acetaminophen for postoperative pain relief. Research has shown that using ibuprofen and acetaminophen together can relieve pain better than using either one alone. Participants in this trial may receive alternating doses of ibuprofen and acetaminophen, which studies suggest provide effective pain relief with fewer side effects compared to other options. Alternatively, some participants will receive both medications simultaneously, a method that can reduce pain more effectively after surgery. Both methods help manage pain without the need for stronger medications.12346
Who Is on the Research Team?
Keri Discepolo, DDS MPH
Principal Investigator
BU Goldman School of Dental Medicine, Pediatrics
Are You a Good Fit for This Trial?
This trial is for young children who have undergone dental rehabilitation under general anesthesia and need pain management. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of three analgesic regimens (ibuprofen monotherapy, alternating ibuprofen and acetaminophen, or combined ibuprofen and acetaminophen) for 24 hours post-surgery
Follow-up
Participants are monitored for pain and discomfort using the DDQ-8 and FLACC scales
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen
- Ibuprofen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston University
Lead Sponsor
Franciscan Hospital For Children, INC.
Collaborator