RecruitingPhase 4NCT05919745

Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical Trial

Sponsor

Marquette University

Enrollment

50 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Quality of Life Pain, Post Operative

Summary

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?

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Age >18 years
Good general health (controlled conditions)
Fluent in English
Treatment-planned for single site extraction and bone graft surgery

Exclusion Criteria15

Pregnancy
Site with active infection i.e purulence, abscess formation
Patients experiencing pain pre-operatively
Oral surgery in more than one site/quadrant in the same session
Patients receiving surgery under sedation
Patients with any contraindication for oral bone grafting surgery (e.g., on anticoagulants, medication-related osteonecrosis of the jaw, etc.)
Patients experiencing acute or chronic oral pain due to conditions or previous interventions
Patients with diseases or taking medications that affect hard and soft tissue wound healing such as poorly controlled diabetes, bisphosphonate use, corticosteroid use, chemotherapy, immunosuppressive therapy, etc.
Current or chronic (≥4 weeks) use of anti-inflammatory, analgesic, corticosteroid or sedative medications in the past 6 months
Health conditions that contraindicate the use of NSAIDs, such as stomach ulcers, bleeding disorders, renal disfunction, liver cirrhosis or acute liver disease, etc.
Intake of medications that interact with NSAIDs or whose actions can be affected by NSAIDs, such as anticoagulant/antiplatelet medications, ACE inhibitors, diuretics, etc.
Allergy to ibuprofen, acetaminophen and/or aspirin, and study materials (e.g., sutures, grafts, membranes?).
Patients having 3 or more alcoholic beverages daily
Patients who are planned to undergo heart surgery or had heart surgery less than 6 months prior
Not fluent in English

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Interventions

DRUGIbuprofen 600 mg

Preoperative delivery of ibuprofen per os.

DRUGPlacebo

Preoperative delivery of placebo per os.

DRUGAcetaminophen

Both groups will be given rescue medication in the form of 1,000 mg tabs of acetaminophen every 6 hours per os as needed for pain (maximum allowed daily dose 4,000 mg per FDA) and will be allowed to receive ibuprofen or other analgesic medication as needed if pain is not controlled by acetaminophen alone. The subjects will receive the rescue medication pills at the end of the surgical appointment.