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

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to compare patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery in patients who received preemptive ibuprofen versus placebo. Participants will receive ibuprofen 600mg or placebo by mouth with water 1 hour prior to extraction and bone graft surgery. The primary question it aims to answer is: • Does preemptive ibuprofen have an effect on postoperative pain 1 hour following extraction and bone graft surgery compared to placebo? Secondary questions are: * Does preemptive ibuprofen have an effect on pain during the first 3 postoperative hours and 7 postoperative days following extraction and bone graft surgery compared to placebo? * Does preemptive ibuprofen have an effect on oral health-related quality of life during the 7 postoperative days following extraction and bone graft surgery compared to placebo?

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 data supports the effectiveness of the drug ibuprofen for postoperative pain?

Research shows that ibuprofen is effective for relieving mild to moderate postoperative pain. In studies, it was found to be more effective than acetaminophen-codeine and had a longer duration of action, making it a suitable alternative for managing pain after surgery. ^{1 2 3 4 5}

Is ibuprofen generally safe for humans?

Ibuprofen has been shown to be safe for humans over many years of use, with side effects similar to a placebo (a harmless pill used for comparison in studies). It is widely used for pain relief and has a strong safety record compared to other pain medications. ^{1 2 6 7 8}

How does ibuprofen differ from other drugs for postoperative pain?

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that is effective for mild to moderate postoperative pain and has a longer duration of action compared to acetaminophen-codeine. It is a suitable alternative with negligible side effects, making it a safe option for managing postoperative pain. ^{1 2 4 9 10}

Research Team

Vrisiis Kofina, DDS, MS

Principal Investigator

Marquette University

Eligibility Criteria

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

I am older than 18 years.

Good general health (controlled conditions)

Fluent in English

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Narrative Summary of Recently Published Literature on Intravenous Ibuprofen. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Addition of Preoperative Intravenous Ibuprofen to Pregabalin on Postoperative Pain in Posterior Lumbar Interbody Fusion Surgery. [2022]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. [2016]

7. Poland pubmed.ncbi.nlm.nih.gov

Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety profile: fifteen years of clinical experience with ibuprofen. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Single dose oral ibuprofen and diclofenac for postoperative pain. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone. [2022]