Variability in analgesic response to ibuprofen
Brief description of study
The objectives of the study are:
- To investigate demographic, clinical, genetic, and environmental factors that contribute to variability in analgesic response to ibuprofen.
- To compare the inflammatory profile and neutrophil phenotypes between patients who use supplemental opioids and those who do not.
- To establish a well-phenotyped cohort of subjects, with biobanked samples, that can be re-contacted about participation in future mechanistic studies of NSAID response. Use of opioid rescue analgesic, in addition to standard of care ibuprofen + acetaminophen, during the first week after third molar extraction Secondary outcome variables include:
- Pain scores on a 0-10 numeric rating scale throughout the study period.
- Number of doses of opioid rescue analgesic taken over the study period.
- COX-1 and COX-2 activity as assessed ex vivo using whole blood assays and in vivo by measuring urinary excretion of prostaglandin metabolites.
- Ibuprofen pharmacokinetic profiles and drug exposure.
- mRNA expression in PBMCs and discarded tissue.
- Biomarkers of systemic inflammation, including CBC with differential, CRP, and cytokines.
- Neutrophil phenotype and COX activity
- Analysis of the oral and gut microbiome.
- Urinary and plasma lipidomics and metabolomics.
- DNA sequencing to identify genetic polymorphisms that modify the response to ibuprofen.
Detailed description of study
The research study is being conducted to learn how patients who have their wisdom teeth removed respond to the pain-relieving drug ibuprofen. We know already that most people do well with ibuprofen. However, some experience insufficient pain relief and need a different type of pain reliever added to their regimen. We are looking for personal characteristics and substances in blood and urine that can help us understand why some people do not experience good relief from ibuprofen.
Most of the procedures in the study are standard of care. if you agree to join the study, you will additionally be asked to complete the following research procedures:
-Two additional visits and, on the day of surgery, an approximately 6-9 hours stay at one of our clinical trial sites. The locations will be performed at Penn Dental Medicine oral surgery clinics.
-Urine and blood samples will be collected for research purposes
- You will be asked to rate your pain and answer questionnaires.
-Following surgery, you will be treated with ibuprofen(400mg) for pain. If your pain does not go away, you will receive a dose of a pain reliever oxycodone(5mg). At home, you will take ibuprofen (400mg) and acetaminophen (500mg) every 4 hours for two days, then only when needed for pain.
You will return for a follow-up 24 hours after surgery
-Urine and blood samples will be collected and pain and medication diary reviewed
You will return for a follow-up 1 week after your surgery
-Urine and blood samples will be collected and pain and medication diary reviewed
Your participation will last for approximately two to four weeks.
If you are interested in participating, a team member of the study team will review the full information with you. You are free to decline or stop participation at any time during or after the initial consenting process.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: - 99 Years
-
Gender: All
Impacted 3rd molars (wisdom teeth)
Find a site
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
