50 Participants Needed

Ibuprofen for Postoperative Pain

VK
CG
Overseen ByChristos Gousias, DDS
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 7 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12678

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.124910

Research Team

VK

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
See 1 more

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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ibuprofen group or Test GroupExperimental Treatment2 Interventions
Subjects will be given ibuprofen 600mg tab 1h prior to surgery.
Group II: Placebo group or Control groupPlacebo Group2 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

Find a Clinic Near You

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

References

Relief of postoperative pain by ibuprofen: a report of two studies. [2020]
Ibuprofen in the treatment of postoperative pain. [2020]
Narrative Summary of Recently Published Literature on Intravenous Ibuprofen. [2021]
Effects of Addition of Preoperative Intravenous Ibuprofen to Pregabalin on Postoperative Pain in Posterior Lumbar Interbody Fusion Surgery. [2022]
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]
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. [2016]
Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland. [2022]
Safety profile: fifteen years of clinical experience with ibuprofen. [2019]
Single dose oral ibuprofen and diclofenac for postoperative pain. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone. [2022]
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