375 Participants Needed

Ibuprofen + Acetaminophen vs Ibuprofen for Orofacial Pain

CM
Overseen ByClifton M Carey, PhD

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

I am not currently taking any antibiotics or painkillers.
I had any necessary teeth extractions done at least 2 weeks before my braces were put on.
I am healthy with no major medical issues.
See 4 more

Exclusion Criteria

I have had bleeding in my stomach.
I have difficulty making decisions due to a cognitive or mental health condition.
Prisoners
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a combined ibuprofen and acetaminophen regimen, ibuprofen alone, or placebo for pain management after orthodontic appliance placement

4 days
Daily self-administration

Follow-up

Participants are monitored for pain levels and compliance using a visual analogue score (VAS) over the treatment period

4 days

Treatment Details

Interventions

  • Acetaminophen
  • Ibuprofen
  • Placebo oral tablet
Trial Overview The study aims to determine if a combination of ibuprofen (200 mg) and acetaminophen (650 mg) is more effective in managing pain after orthodontic appliance placement than just ibuprofen alone or a placebo. Participants will be randomly assigned to one of these three treatments for four days.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Ibuprofen and acetaminophenExperimental Treatment1 Intervention
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
Group II: IbuprofenActive Control1 Intervention
one 200 mg tablet of ibuprofen and 2 placebo tablets
Group III: PlaceboPlacebo Group1 Intervention
3 tablets of tableting compounds with no active ingredients

Acetaminophen is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Tylenol for:
  • Pain relief
  • Fever reduction
🇪🇺
Approved in European Union as Paracetamol for:
  • Pain relief
  • Fever reduction
🇨🇦
Approved in Canada as Tylenol for:
  • Pain relief
  • Fever reduction

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Findings from Research

Ibuprofen is an effective analgesic for various pain conditions in children, including musculoskeletal pain, ear pain, and postoperative pain, making it a suitable choice for treating mild to moderate pain.
The safety profile of ibuprofen is favorable, with mild side effects and the lowest gastrointestinal toxicity among NSAIDs, although it should be avoided in dehydrated patients due to potential renal risks.
Ibuprofen in the treatment of children's inflammatory pain: a clinical and pharmacological overview.Barbagallo, M., Sacerdote, P.[2019]
In a study of 60 patients, strepfen (flurbiprofen) provided similar pain relief for throat pain compared to paracetamol, but acted much faster, with effects starting within 5-15 minutes versus 30-45 minutes for paracetamol.
Strepfen was well tolerated with no serious side effects reported, making it a safe option for treating throat pain in both acute and chronic pharyngeal conditions.
[Results of an open prospective controlled randomized comparative trial of flurbiprofen and paracetamol efficacy and tolerance in patients with throat pain].Sedinkin, AA., Balandin, AV., Dimova, AD.[2013]
In a study involving 159 oral surgery outpatients, diflunisal at doses of 500 mg and 1,000 mg was found to be significantly more effective than acetaminophen alone for pain relief, with effects lasting throughout a 12-hour observation period.
Diflunisal's analgesic efficacy was comparable to that of a combination of acetaminophen and codeine, and importantly, none of the active treatments caused more side effects than the placebo, indicating a favorable safety profile.
Diflunisal. A new oral analgesic with an unusually long duration of action.Forbes, JA., Beaver, WT., White, EH., et al.[2020]

References

Ibuprofen in the treatment of children's inflammatory pain: a clinical and pharmacological overview. [2019]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Results of an open prospective controlled randomized comparative trial of flurbiprofen and paracetamol efficacy and tolerance in patients with throat pain]. [2013]
Diflunisal. A new oral analgesic with an unusually long duration of action. [2020]
Measurement of antipyretic activity of ibuprofen and paracetamol in children. [2019]
Comparison of flurbiprofen and acetaminophen with codeine in postoperative foot pain. [2020]
Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies. [2021]
Safety warning: combination products containing codeine and ibuprofen. [2023]
An integrated safety analysis of combined acetaminophen and ibuprofen (Maxigesic ® /Combogesic®) in adults. [2023]
Risk factors for adverse events in analgesic drug users: results from the PAIN study. [2013]
Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. [2019]
Tolerability of ibuprofen, aspirin and paracetamol for the treatment of cold and flu symptoms and sore throat pain. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Five studies on ibuprofen for postsurgical dental pain. [2020]
A prospective survey to compare the suitability profiles of over-the-counter ibuprofen and paracetamol use in a French general practitioner-controlled population. [2018]
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