Ibuprofen + Acetaminophen vs Ibuprofen for Orofacial Pain
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires that you are not currently taking antibiotics or pain relievers (analgesics) before participating.
Will I have to stop taking my current medications?
The trial requires that you are not currently taking antibiotics or pain relievers (analgesics) to participate.
What data supports the idea that Ibuprofen + Acetaminophen vs Ibuprofen for Orofacial Pain is an effective drug?
The available research does not directly compare the combination of Ibuprofen and Acetaminophen to Ibuprofen alone for orofacial pain. However, it does show that Ibuprofen is effective for various types of pain, including toothache and other oral pain conditions. Additionally, Acetaminophen is often used for pain relief. While there is no specific data on the combination for orofacial pain, the individual effectiveness of these drugs suggests that their combination could be beneficial. Other studies mentioned show that Ibuprofen is effective for children's pain and has a good safety profile, while Acetaminophen is commonly used for pain relief. Therefore, combining these two could potentially enhance pain relief, although specific studies on orofacial pain are needed to confirm this.12345
What evidence supports the effectiveness of using ibuprofen and acetaminophen together for orofacial pain?
Ibuprofen has been shown to be effective for various types of pain, including toothache and inflammatory conditions in the mouth and throat, making it a reasonable choice for orofacial pain. Additionally, acetaminophen has been effective in reducing pain, as demonstrated in studies comparing it to other pain relievers.12345
What safety data exists for the combination of ibuprofen and acetaminophen for orofacial pain?
The combination of ibuprofen and acetaminophen has been shown to provide effective pain relief with a safety profile similar to ibuprofen alone. Studies indicate that both drugs are safe at recommended doses, but high doses or chronic use can pose risks. Acetaminophen is linked to liver injury, while ibuprofen can cause gastric bleeding and thromboembolic events. However, using them together offers superior analgesia without exceeding safe daily dose limits. In children, ibuprofen is effective for various pain conditions with mild side effects, though caution is advised in cases of dehydration. Overall, the combination is considered safe and effective for managing pain.16789
Is the combination of ibuprofen and acetaminophen safe for treating pain?
The combination of ibuprofen and acetaminophen is generally considered safe at recommended doses, providing effective pain relief without exceeding daily dose limits. However, high doses or long-term use can increase risks, such as liver damage from acetaminophen and stomach bleeding from ibuprofen. In children, ibuprofen is effective for various pains with mild side effects, but it should be avoided if the child is dehydrated.16789
Is the drug Acetaminophen, Ibuprofen, Placebo a promising treatment for orofacial pain?
Yes, Ibuprofen is a promising drug for orofacial pain. It is effective for various types of pain, including dental pain, and is well-tolerated compared to other pain relievers like aspirin. Acetaminophen is also commonly used for pain relief, but the studies highlight Ibuprofen's effectiveness in similar situations.110111213
How does the drug combination of ibuprofen and acetaminophen differ from other treatments for orofacial pain?
The combination of ibuprofen and acetaminophen for orofacial pain is unique because it combines two well-tolerated pain relievers, each with different mechanisms of action, potentially offering enhanced pain relief compared to using ibuprofen alone. Ibuprofen is an anti-inflammatory drug, while acetaminophen works primarily to relieve pain and reduce fever, making their combination potentially more effective for managing pain with an inflammatory component.110111213
What is the purpose of this trial?
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
Eligibility Criteria
This trial is for healthy individuals aged 12 and above who are about to start comprehensive orthodontic treatment, have not taken antibiotics or painkillers recently, and have no allergies to ibuprofen or acetaminophen. It excludes those under 12 or over 80, pregnant women, prisoners, people with decision-making impairments, kidney disease, liver issues, alcoholism, stomach ulcers or bleeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a combined ibuprofen and acetaminophen regimen, ibuprofen alone, or placebo for pain management after orthodontic appliance placement
Follow-up
Participants are monitored for pain levels and compliance using a visual analogue score (VAS) over the treatment period
Treatment Details
Interventions
- Acetaminophen
- Ibuprofen
- Placebo oral tablet
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 Colorado, Denver
Lead Sponsor