A Phase 4 interventional study of Ibuprofen 600 mg and Placebo in Pain, Post Operative and Quality of Life, sponsored by Marquette University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Marquette University · Phase 4, Interventional, and Supportive care
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:
Secondary questions are:
The null hypothesis of this randomized clinical trial is that there is no difference in patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery between patients who received 600mg of preemptive ibuprofen versus placebo.
Participants will receive ibuprofen 600mg (test group) or placebo (control group) per os 1 hour prior to extraction and bone graft surgery. Researchers and patients will be blinded to the group assignment. Both groups will be given rescue medication in the form of 1,000 mg tabs of acetaminophen every 6 hours 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.
Patient-reported pain will be collected by Visual Analogue Scale (VAS) before surgery, every hour for the first 3 postoperative hours and on postoperative days 1-7. VAS for patient-reported swelling will also be recorded at the same time points. Number of rescue medications will be recorded at the same postoperative time points. Oral health-related quality of life as expressed by Oral Health Impact Profile-14 (OHIP-14) questionnaire will be reported before surgery and on postoperative days 2, 5 and 7. Questionnaires on dental anxiety (Modified Dental Anxiety Scale), oral health literacy (Rapid estimate of Adult Literacy in Dentistry 30 Short Form), fear of pain (Fear of pain questionnaire-9) and pain catastrophizing (Pain catastrophizing scale) will be collected prior to surgery and will be evaluated as pain modifiers. Anticipated pain will be reported prior to surgery and questions on comparison between actual and anticipated pain and willingness to undergo a similar procedure again will be asked on days 1 and 7. Surgical and demographic data as well as medical history will be collected on the day of surgery. Clinical wound healing observations will be recorded on day 7.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Marquette University is the lead sponsor of 38 studies on the registry; 10 are open to participants now.
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Exclusion criteria
Subjects will be given ibuprofen 600mg tab 1h prior to surgery.
Drug: Ibuprofen 600 mg · Drug: Acetaminophen
Subjects will be given a placebo tab 1h prior to surgery.
Drug: Placebo · Drug: Acetaminophen
Preoperative delivery of ibuprofen per os.
Also known as: Test
Preoperative delivery of placebo per os.
Also known as: Control
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.
Also known as: Rescue medication
Difference in patient-reported postoperative pain between test and control group
Visual Analogue Scale will be used to measure patient-reported pain. Its score range from 0-100 and the higher the score, the worse the reported pain is. Specifically, zero represents no pain and 100 represents the worst pain imaginable.
Time frame: 1 hour following extraction and bone graft surgery
Difference in patient-reported postoperative pain between test and control group
Visual Analogue Scale will be used to measure patient-reported pain. Its score range from 0-100 and the higher the score, the worse the reported pain is. Specifically, zero represents no pain and 100 represents the worst pain imaginable.
Time frame: Postoperative hours 2 and 3, and postoperative days 1, 2, 3, 4, 5, 6 and 7 following extraction and bone graft surgery.
Difference in Oral Health Impact Profile-14 between test and control group
Oral Health Impact Profile-14 is a validated widely used questionnaire that reliably measures oral health-related quality of life by recording patient perception of the impact of oral conditions on their well-being. Specifically, it consists of seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Its scores range from 0-56 and the higher the total score, the more impacted, i.e., worse, the quality of life is.
Time frame: Postoperative days 2, 5 and 7 following extraction and bone graft surgery
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Dec 2026, 38 months after the start.
Of 492 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 38 months is above that.
Counting every sponsor, half of 497 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
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Studies of the drug tested here: Ibuprofen
Marquette University