Ibuprofen for Postoperative Pain

Overseen By Christos Gousias, DDS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Marquette University

Must not be taking: Anticoagulants, Bisphosphonates, Corticosteroids, others

Disqualifiers: Pregnancy, Active infection, Oral pain, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if taking ibuprofen before a tooth extraction and bone graft reduces pain and improves oral health in the week following surgery. Participants will receive either ibuprofen, a common pain reliever, or a placebo, a sugar pill, one hour before their procedure to assess its impact on pain levels and quality of life. Suitable candidates for this trial are healthy individuals scheduled for a single tooth extraction with bone graft surgery who are not experiencing pain beforehand. As a Phase 4 trial, this research seeks to understand how the already FDA-approved ibuprofen benefits more patients, offering an opportunity to contribute to broader oral health improvements.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, such as anti-inflammatory drugs, pain relievers, corticosteroids, or sedatives, for at least 4 weeks before participating. If you are on medications that affect wound healing or interact with NSAIDs, you may not be eligible to participate.

What is the safety track record for ibuprofen?

Research has shown that ibuprofen is generally safe and effective for managing post-surgical pain. Studies have found that doses of 200 mg and 400 mg can significantly relieve pain in many individuals with moderate to severe pain. Additionally, administering ibuprofen intravenously can effectively reduce pain and is less likely to cause nausea and vomiting.

Ibuprofen, a common pain reliever and anti-inflammatory medication, is widely used and considered safe when taken as directed. In this trial, participants will receive a 600 mg dose, which is typical. While all medications can have side effects, ibuprofen is generally safe for most people when used correctly. Always consult a healthcare provider to understand personal risks and benefits. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for postoperative pain, which often includes opioids with potential for addiction and side effects, ibuprofen offers a non-opioid alternative. Researchers are excited about ibuprofen because it targets inflammation directly and provides effective pain relief without the addiction risk associated with opioids. This makes it a safer option for managing pain after surgery, potentially reducing the need for stronger painkillers and minimizing side effects.

What is the effectiveness track record for ibuprofen in managing postoperative pain?

Research shows that ibuprofen helps reduce pain after surgery. Studies have found that even smaller doses, like 200 mg and 400 mg, significantly relieve pain for about half of the people with moderate to severe pain post-surgery. Strong evidence supports ibuprofen as a reliable choice for managing this type of pain, and many doctors and patients trust it for postoperative relief. In this trial, participants in the ibuprofen group will receive a 600 mg dose one hour before surgery to evaluate its effectiveness in managing postoperative pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Vrisiis Kofina, DDS, MS

Principal Investigator

Marquette University

Are You a Good Fit for This Trial?

This trial is for adults over 18 in good health who speak English and are scheduled for a single site tooth extraction and bone graft. It's not suitable for those with certain health conditions that aren't well-controlled.

Inclusion Criteria

Good general health (controlled conditions)

Fluent in English

I am older than 18 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ibuprofen 600mg or placebo 1 hour prior to extraction and bone graft surgery

1 day

1 visit (in-person)

Postoperative Monitoring

Patient-reported pain and oral health-related quality of life are assessed using VAS and OHIP-14 over 7 days

7 days

Daily assessments (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical wound healing observations

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ibuprofen

Trial Overview

The study tests if taking ibuprofen before surgery can reduce pain after tooth extraction and bone grafting compared to a placebo. Patients will be randomly assigned to receive either ibuprofen or a placebo before their procedure.

How Is the Trial Designed?

Group I: Ibuprofen group or Test Group Experimental Treatment 2 Interventions

Subjects will be given ibuprofen 600mg tab 1h prior to surgery.

Group II: Placebo group or Control group Placebo Group 2 Interventions

Subjects will be given a placebo tab 1h prior to surgery.

Ibuprofen is already approved in United States, Canada, European Union, Japan, China, Switzerland for the following indications:

Approved in United States as Advil for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Canada as Motrin for:

• Pain relief
• Fever reduction
• Inflammation

Approved in European Union as Nurofen for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Japan as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation

Approved in China as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Switzerland as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

Published Research Related to This Trial

In a study involving 425 patients with postherniorrhaphy pain, 400 mg of ibuprofen was found to be more effective than a placebo and as effective as a compound analgesic containing acetylsalicylic acid, caffeine, and codeine.

The side effects of ibuprofen and the other medications tested were negligible, suggesting that ibuprofen is a safe and suitable alternative for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief of postoperative pain by ibuprofen: a report of two studies. Iles, JD.[2020]

Ibuprofen is an effective and safe option for managing mild to moderate postoperative pain, as demonstrated in controlled clinical trials.

In a study involving 120 patients with postoperative orthopedic pain, ibuprofen outperformed acetaminophen-codeine in effectiveness and provided longer-lasting relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. Slavic-Svircev, V., Heidrich, G., Kaiko, RF., et al.[2020]

Ibuprofen and diclofenac are both effective for postoperative pain relief, with similar efficacy observed in direct comparisons; the number-needed-to-treat (NNT) for diclofenac 100 mg is 1.8, indicating it is slightly more effective than ibuprofen at certain doses.

The choice between ibuprofen and diclofenac should consider factors such as dosage, safety, and cost, as both drugs provide significant pain relief in moderate to severe postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single dose oral ibuprofen and diclofenac for postoperative pain. Collins, SL., Moore, RA., McQuay, HJ., et al.[2018]

In a study of 42 patients undergoing posterior lumbar interbody fusion surgery, the addition of 800 mg intravenous ibuprofen to a preoperative dose of pregabalin significantly reduced postoperative pain at multiple time points compared to the control group.

The combination of ibuprofen and pregabalin also led to lower total morphine consumption for pain management, demonstrating an effective multimodal analgesia approach without increasing the risk of bleeding or other side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Addition of Preoperative Intravenous Ibuprofen to Pregabalin on Postoperative Pain in Posterior Lumbar Interbody Fusion Surgery. Pınar, HU., Karaca, Ö., Karakoç, F., et al.[2022]

Intravenous ibuprofen (IVIB) provides significantly higher plasma levels compared to oral ibuprofen, leading to better postoperative pain management and reduced opioid use in a review of 9 studies involving 1062 patients.

IVIB has a favorable safety profile, with fewer adverse events and improved recovery outcomes, making it a strong candidate for inclusion in multimodal pain management strategies for pre- and postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative Summary of Recently Published Literature on Intravenous Ibuprofen. Southworth, SR., Sellers, JA.[2021]

A pooled analysis of five Phase III studies involving 362 participants for IBU sodium (IBU(Na)) and 342 for standard ibuprofen showed that IBU(Na) has a safety profile comparable to standard ibuprofen and placebo, with treatment-emergent adverse events occurring in only 5% of cases.

The most common adverse event was nausea, but overall, IBU(Na) demonstrated a favorable safety profile, suggesting it is a viable alternative for rapid pain relief without increased risk of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Jayawardena, S., Leyva, R., Kellstein, D.[2016]

In a study involving 200 patients undergoing elective septoplasty, lornoxicam was found to be effective in managing acute postoperative pain, but its efficacy was not superior to that of other nonopioid analgesics like diclofenac, ketoprofen, and dipyrone.

Patients receiving placebo required significantly more additional analgesia (pethidine) compared to those receiving active treatments, indicating that all active medications provided better pain relief than placebo, with no significant differences in adverse effects among the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone. Sener, M., Yilmazer, C., Yilmaz, I., et al.[2022]

Over a 10-year period, a total of 29,656,286 units of various ibuprofen formulations were sold in Poland, with only 5 spontaneous reports of adverse effects, indicating that ibuprofen is a very safe medication with rare side effects.

The study suggests that while ibuprofen is generally safe, the current monitoring system for adverse effects in Poland is insufficient and requires enhancements to better detect potential issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland. Kuchari, E., Han, S., Karłowicz-Bodalska, K., et al.[2022]

In a study of 68 pediatric patients who underwent open cardiac surgery, the addition of intravenous ibuprofen significantly reduced opioid consumption (fentanyl) in the first 24 hours post-surgery, indicating its effectiveness in pain management.

The use of intravenous ibuprofen also resulted in lower pain scores at multiple time points without increasing the risk of side effects such as bleeding, vomiting, or renal dysfunction, suggesting it is a safe addition to postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Analgesic Effects of the Addition of Intravenous Ibuprofen to a Multimodal Analgesia Regimen for Pain Management After Pediatric Cardiac Surgery: A Randomized Controlled Study. Abdelbaser, I., Abo-Zeid, M., Hayes, S., et al.[2023]

Ibuprofen has been proven to be safe and effective for treating pain, menstrual cramps, inflammation, and fever since its introduction in 1974.

A comprehensive review of data over the years shows that ibuprofen has a better safety profile compared to aspirin and other nonsteroidal anti-inflammatory drugs, suggesting continued safety for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile: fifteen years of clinical experience with ibuprofen. Royer, GL., Seckman, CE., Welshman, IR.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4171980/

Single dose oral ibuprofen for acute postoperative pain in adults

Ibuprofen at 200 mg and 400 mg produces a high level of pain relief in about half of those with moderate or severe acute postoperative pain.

2.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK542299/

Ibuprofen - StatPearls - NCBI Bookshelf - NIH

Postoperative pain: In a randomized, double-blind study comparing intravenous ibuprofen and acetaminophen administration to treat postoperative ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S014929182500164X

The Safety and Efficacy of Intravenous Ibuprofen in Older ...

In older patients, IVIB treatment resulted in a 24.0% reduction in pain at rest (P = 0.008), a 20.0% reduction in pain with movement (P = 0.001) between 6 and ...

4.

journals.lww.com

journals.lww.com/atmr/fulltext/2024/07000/a_systematic_review_and_meta_analysis_of.34.aspx

A Systematic Review and Meta-analysis of Randomised...

The meta-analysis suggests that ibuprofen may have a modest edge over acetaminophen for pain management, but the findings are inconsistent and vary depending ...

5.

jada.ada.org

jada.ada.org/article/S0002-8177(14)61531-2/fulltext

Good Evidence Supports Ibuprofen as an Effective and ...

A considerable amount of high-quality evidence demonstrates that ibuprofen is an effective analgesic in treating postoperative pain. NNTs for 200-mg and 400 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12117996/

The Adverse Effects Associated With Ibuprofen Use After ...

The PERISAFE trial aims to assess the adverse effects associated with an 8‐day postoperative treatment with ibuprofen after hip and knee ...

7.

nature.com

nature.com/articles/s41598-018-28428-4

A prospective, randomized, double-blind, placebo ...

IV ibuprofen 800 mg significantly reduced pain at rest and with movement in postoperative pain management. A meta-analysis of 17 randomized ...

8.

bpspubs.onlinelibrary.wiley.com

bpspubs.onlinelibrary.wiley.com/doi/10.1002/prp2.1123

Intravenous ibuprofen in postoperative pain and fever ...

In terms of safety, IVIB was well-tolerated for both pain and fever management and was associated with a lower incidence of nausea and vomiting ...