Ibuprofen + Acetaminophen vs Ibuprofen for Orofacial Pain

Overseen By Clifton M Carey, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must not be taking: Antibiotics, Analgesics, Blood thinners

Disqualifiers: Pregnancy, Kidney disease, Liver disease, Alcoholism, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

375 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking both ibuprofen and acetaminophen reduces pain more effectively than ibuprofen alone or a placebo (a pill with no active ingredients) after receiving braces. The researchers believe this combination will ease discomfort better than ibuprofen alone. Individuals beginning orthodontic treatment and not currently using painkillers or antibiotics might be suitable for this study. As an Early Phase 1 trial, this research aims to understand how the combination treatment works in people, offering participants a chance to contribute to groundbreaking pain management research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking ibuprofen and acetaminophen together is usually safe. A large study with 706 patients found this combination effectively managed pain without causing serious side effects. Another study found that 70% of participants experienced good pain relief with this combination, indicating its effectiveness for pain management.

Ibuprofen alone is also considered a safe option for reducing pain and is often used for dental and other types of pain. It belongs to a group of medicines called NSAIDs, which many people use without problems.

Overall, both treatments have been safely used by many. However, since each body is different, it is important to consider individual health conditions and consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for orofacial pain, which typically involve either ibuprofen or acetaminophen alone, this combination treatment leverages both. Researchers are excited because combining ibuprofen, a non-steroidal anti-inflammatory drug, with acetaminophen, a pain reliever, could offer a more robust pain relief experience. This dual approach might enhance effectiveness by targeting pain through two different mechanisms, potentially providing faster and more comprehensive relief than using either medication by itself.

What evidence suggests that this trial's treatments could be effective for orofacial pain?

This trial will compare the effectiveness of ibuprofen alone versus a combination of ibuprofen and acetaminophen for orofacial pain. Research has shown that taking both ibuprofen and acetaminophen together can relieve pain more effectively than taking either one alone. Specifically, one study found that people using this combination experienced better pain relief than those using just ibuprofen or acetaminophen. This combination might even serve as a good alternative to opioids for various types of pain.

Participants in this trial may receive ibuprofen by itself, which is well-known for reducing pain and swelling, especially after dental work. Studies indicate that ibuprofen outperforms some other pain relievers for sudden dental pain, making it a dependable choice for easing discomfort. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have had bleeding in my stomach.

I have difficulty making decisions due to a cognitive or mental health condition.

Prisoners

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Ibuprofen and acetaminophen Experimental Treatment 1 Intervention

one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen

Group II: Ibuprofen Active Control 1 Intervention

one 200 mg tablet of ibuprofen and 2 placebo tablets

Group III: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of children's inflammatory pain: a clinical and pharmacological overview. Barbagallo, M., Sacerdote, P.[2019]

In five studies using the Dental Pain Model, ibuprofen 400 mg was consistently more effective than aspirin 650 mg and acetaminophen 600 mg for managing acute postsurgical pain.

Ibuprofen 400 mg was found to be at least as effective as zomepirac sodium 100 mg, and no serious or prolonged side effects were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five studies on ibuprofen for postsurgical dental pain. Cooper, SA.[2020]

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued a warning about the serious risks associated with the combination of codeine and ibuprofen, particularly concerning renal and gastrointestinal harms.

This warning highlights the need for careful consideration of the safety profile of this medication combination, emphasizing potential adverse effects that could impact patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety warning: combination products containing codeine and ibuprofen. [2023]

In a study of 8677 patients, the use of analgesics like paracetamol, aspirin, and ibuprofen showed that the main risk factors for serious adverse events (SAE) included the type of pain being treated and the number of other medications taken, with higher risks associated with more medications.

Patients taking aspirin had a higher risk of SAE compared to those taking paracetamol, while ibuprofen was associated with fewer gastrointestinal adverse events, highlighting the importance of medication choice and patient history in managing pain safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events in analgesic drug users: results from the PAIN study. Moore, N., Charlesworth, A., Van Ganse, E., et al.[2013]

The fixed-dose combination (FDC) of ibuprofen (250 mg) and acetaminophen (500 mg) demonstrated superior pain relief compared to individual doses of ibuprofen (250 mg) and acetaminophen (650 mg) in two phase 3 studies involving a total of 691 patients, with significant efficacy observed within the first hour and lasting over 8 hours.

The FDC was well tolerated, showing the lowest rates of adverse events compared to the individual components, making it a promising non-opioid option for managing acute dental pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Searle, S., Muse, D., Paluch, E., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diflunisal. A new oral analgesic with an unusually long duration of action. Forbes, JA., Beaver, WT., White, EH., et al.[2020]

In a study of 43 children undergoing bilateral myringotomy and tube placement, preoperative administration of either acetaminophen or ibuprofen did not significantly reduce postoperative pain compared to a placebo.

The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores showed no differences among the groups at various time points, indicating that neither analgesic provided effective pain relief in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. Bennie, RE., Boehringer, LA., McMahon, S., et al.[2019]

In a study of 2,815 patients with mild to moderate pain from cold/flu symptoms or sore throat, ibuprofen was found to be significantly better tolerated than aspirin, with a lower rate of significant adverse events (12.0% for ibuprofen vs. 15.7% for aspirin).

Ibuprofen's tolerability was comparable to that of paracetamol (12.3%), indicating that it is a safe over-the-counter option for pain relief in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of ibuprofen, aspirin and paracetamol for the treatment of cold and flu symptoms and sore throat pain. Moore, N., Le Parc, JM., van Ganse, E., et al.[2013]

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.

NCBI (Pubmed)

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]. Sedinkin, AA., Balandin, AV., Dimova, AD.[2013]

In a double-blind study comparing flurbiprofen and acetaminophen with codeine in 96 postoperative hours after foot surgery, both treatments showed similar efficacy in pain relief, with no significant differences in pain intensity or patient evaluations.

However, the acetaminophen with codeine group had a higher incidence of study termination due to side effects, suggesting that flurbiprofen may be a safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of flurbiprofen and acetaminophen with codeine in postoperative foot pain. Ottinger, ML., Kinney, KW., Black, JR., et al.[2020]

A fixed-dose combination of acetaminophen (APAP) and ibuprofen (IBP) was found to be well tolerated in a study involving 922 patients, with adverse events similar to or lower than those seen with either drug alone or placebo.

The combination therapy provided superior pain relief compared to monotherapy, while maintaining a strong safety profile without increasing the risk of common adverse events like gastrointestinal issues or postoperative bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated safety analysis of combined acetaminophen and ibuprofen (Maxigesic &#174; /Combogesic&#174;) in adults. Aitken, P., Stanescu, I., Playne, R., et al.[2023]

In a survey of 5000 patients, nearly 50% were found to have contraindications for ibuprofen, suggesting that many individuals may not safely use this common over-the-counter pain reliever, while only 6.8% had contraindications for paracetamol.

The findings indicate that the results of the PAIN study, which suggested similar tolerability for ibuprofen and paracetamol, may not apply to the general population, as the study excluded many patients who could be at risk when using ibuprofen without medical supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective survey to compare the suitability profiles of over-the-counter ibuprofen and paracetamol use in a French general practitioner-controlled population. Pigeon, P., Robillard, E., Clarke, GD., et al.[2018]

In a study of 22 children with fever, both ibuprofen and paracetamol effectively reduced body temperature, but ibuprofen showed a greater effect at 6 and 8 hours post-administration.

Ibuprofen not only had a longer duration of action compared to paracetamol but also offered additional anti-inflammatory benefits, making it potentially more advantageous for treating certain upper respiratory infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of antipyretic activity of ibuprofen and paracetamol in children. Sheth, UK., Gupta, K., Paul, T., et al.[2019]

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