Ibuprofen for Postoperative Pain
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?
Is ibuprofen generally safe for humans?
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibuprofen 600mg or placebo 1 hour prior to extraction and bone graft surgery
Postoperative Monitoring
Patient-reported pain and oral health-related quality of life are assessed using VAS and OHIP-14 over 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including clinical wound healing observations
Treatment Details
Interventions
- Ibuprofen
Ibuprofen is already approved in United States, Canada, European Union, Japan, China, Switzerland for the following indications:
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marquette University
Lead Sponsor