Impacted Third Molar ToothPhase 1NCT03893175
Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction
A Phase 1 study testing Ibuprofen, Acetaminophen and Oxycodone in people with Impacted Third Molar Tooth and Pain, Acute, run by University of Pennsylvania at 1 site in United States.
Trial summary
This research study will evaluate inter-individual variability in the analgesic response to the non-steroidal anti-inflammatory drug (NSAID) ibuprofen after third molar extraction surgery. It will also investigate demographic, clinical, genetic, and environmental factors that cause this variability. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Impacted Third Molar Tooth, Pain, Acute
- What is being tested?
- Ibuprofen, Acetaminophen and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 2 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women greater than 18 years of age requiring extraction of at least one impacted mandibular third molar tooth (at least 50% covered with bone).
- Body mass index (BMI) between 18 and 30 kg/m2.
- Absence of other major medical problems or contraindications to surgery or study drugs.
- Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening.
- Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and a urine pregnancy test on the day of surgery, which must be negative at all time points.
- Has not ingested caffeine-containing products within 12 hours of surgery.
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- All subjects must consent to a urine drug test at screening. Results must be negative. A positive result will be reported to the subject.
- Does not consume more than 1 alcoholic beverage per day on average.
- Subjects must reach a level of at least moderate pain within four hours of surgery completion, with a pain score greater than or equal to 4 on a 0-10 numerical pain scale
- Subjects must be willing and able to complete safety and efficacy diaries.
- An escort must be available to pick up the subject at the end of at the end of the surgical/dosing visit (Visit #2)
- In the opinion of the investigators or research coordinators, subjects must be willing and able to understand and comply with study procedures, including completing safety and efficacy diaries at home.
- Able and willing to provide written informed consent prior to any study procedures being performed.
Who cannot join
- Female subjects who are pregnant or nursing a child.
- Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects who are sensitive or allergic to ibuprofen, acetaminophen, or their components.
- Subjects who are sensitive or allergic to aspirin or other NSAIDs.
- Subjects who are sensitive or allergic to oxycodone or other opioids (excluding nausea and constipation).
- Presence of a serious medical condition (e.g. poorly controlled hypertension or diabetes, gastrointestinal disorders such as bleeding ulcer, coagulation or bleeding disorders, significantly impaired cardiac, renal, hepatic, respiratory, or thyroid function) that according to the investigator may interfere with interpretation of the study results or compromise the safety of a potential subject.
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- Acute local infection at the time of surgery that could confound post-surgical evaluation.
- Use of any confounding prescription or non-prescription drug within 24 hours of the surgical procedure, including analgesics, sedating antihistamine, sedative, alcohol, or CNS/psychotropic agents (i.e. sleep aids, benzodiazepines, performance/attention enhancers, marijuana, anti-depressants). Hormonal contraceptives, hormone replacement therapy (including males taking testosterone as a hormone replacement to treat a documented low testosterone level), or thyroid replacement hormones are allowed. Individuals taking other/additional chronic stable medications can be considered on a case-by-case basis for inclusion in the study if agreed upon by judgment of the investigator.
- Subjects who have taken NSAIDs, including acetaminophen, or other medications for pain, including aspirin or aspirin-containing products within 1 week of study drug administration.
- Subjects who routinely consume high doses of antioxidant vitamins daily (vitamin C > 1000mg, Vitamin E > 400IU, Beta Carotene > 1000IU, Vitamin A > 5000IU, Selenium > 200mcg, Folic Acid > 1mg) during the 2 weeks prior to the start of the study.
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
- Subjects who have a history of abuse of narcotics, street drugs, prescription sleeping pills, based upon history and judgment of the Investigator.
- Subjects who are unwilling to provide a blood sample for genetic analyses.
- Employees of the principal investigator, sub-investigators, or relative of an employee who is directly involved in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
This research study will evaluate inter-individual variability in the analgesic response to the non-steroidal anti-inflammatory drug (NSAID) ibuprofen after third molar extraction surgery. It will also investigate demographic, clinical, genetic, and environmental factors that cause this variability.
Read the detailed description
The dramatic increase in opioid prescriptions over the past years has been linked to the concomitant rise in opioid addiction and to deaths from opioid abuse. Young adults' initial exposure to opioid analgesics is often following extraction of their impacted third molars, with an average of 5,000,000 cases in the USA per year. Over-prescribing of opioids for surgical pain, often 2-5 times more than patients actually use, further exacerbates this problem, as patients tend to save leftover pills rather than discard them. Up to 70% of individuals who become addicted to prescription opioids had access to leftover pills prescribed for others. This is particularly troubling as the odds of transitioning to heroin from prescription opioid abuse are much higher than other suspected gateway drugs, about 40 fold greater than non-gateway drug users. Heroin is now often laced with fentanyl derivatives making overdose and death more likely in even the most opioid tolerant individuals.
Multiple studies have demonstrated that non-addicting nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac are effective in relieving pain after dental impaction surgery, being at least equally efficacious to optimal doses of immediate release opioid formulations combined with acetaminophen. However, these assessments of pain relief represent average scores and approximately 22% and 50% of individuals required additional opioid-containing rescue analgesics when ibuprofen and diclofenac were employed at FDA-approved dosages. A deeper understanding of the sources of variability in pain relief should allow improvements in the overall efficacy of NSAIDs by targeting treatment to those who are most likely to receive sufficient pain relief. Thus, optimizing pain therapy with NSAIDs by personalization would be expected to help limit the unnecessary prescription of highly addicting immediate release opioids. Moreover, these results may have applicability to other types of pain that are driven by inflammation.
- Conditions
- Impacted Third Molar Tooth, Pain, Acute
- Being tested
- Ibuprofen, Acetaminophen, Placebo, Oxycodone
- Keywords
- Non-steroidal anti-inflammatory drugs
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Advil
400 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction
AcetaminophenDrug
Also called Tylenol
500 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction
PlaceboDrug
By mouth
OxycodoneDrug
5 mg by mouth every 6 hours as needed for pain
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | During the double-blind stage, subjects will receive blinded ibuprofen (400 mg by mouth) when pain is at least 4/10 following third molar extraction.
During the open-label stage, all subjects will receive ibuprofen (400 mg by mouth) and acetaminophen (500 mg by mouth) to be taken every 4 hours around the clock for the first 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction.
Rescue medication (oxycodone 5 mg by mouth) will be available if additional analgesic is requested. Receives: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Oxycodone |
| Placebo | Placebo comparator | During the double-blind stage, subjects will receive blinded placebo when pain is at least 4/10 following third molar extraction.
During the open-label stage, all subjects will receive ibuprofen (400 mg by mouth) and acetaminophen (500 mg by mouth) to be taken every 4 hours around the clock for the first 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction.
Rescue medication (oxycodone 5 mg by mouth) will be available if additional analgesic is requested. Receives: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Placebo; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic response
Use of opioid rescue medication
Measured: Up to 7 days after third molar extraction
Secondary outcomes (15)
Ibuprofen plasma concentrations
Assessed by measuring the amount of ibuprofen in plasma
Measured: Up to 7 days
Acetaminophen plasma concentrations
Assessed by measuring the amount of acetaminophen in plasma
Measured: Up to 7 days
Gene expression profiling
mRNA levels will be measured in peripheral blood mononuclear cells
Measured: Up to 7 days
COX-1 activity
COX-1 activity will be measured ex vivo using a whole blood assay and in vivo by quantifying concentrations of prostaglandin metabolites in urine.
Measured: Up to 7 days
COX-2 activity
COX-2 activity will be measured ex vivo using a whole blood assay and in vivo by quantifying concentrations of prostaglandin metabolites in urine.
Measured: Up to 7 days
DNA sequencing
Assessment of genetic variation
Measured: 1 day
Urinary metabolomics
Assessed by measuring levels of metabolites in urine
Measured: Up to 7 days
Plasma metabolomics
Assessed by measuring levels of metabolites in plasma
Measured: Up to 7 days
Composition of the gut microbiome
Assessed by evaluating the microbes present in a stool sample
Measured: 1 day
Composition of the oral microbiome
Assessed by evaluating the microbes present in an oral swab
Measured: 1 day
Pain intensity score
Rating of pain from 0 (no pain) to 10 (worst imaginable pain)
Measured: Up to 7 days
Inflammatory mediator profiling
Assessment of cytokines in plasma
Measured: Up to 7 days
C-reactive protein
Assessment C-reactive protein in serum
Measured: Up to 7 days
Procalcitonin levels
Assessment of procalcitonin in serum
Measured: Up to 7 days
Complete blood count with differential
Assessment of proportions of red blood cells, white blood cells, and platelets in whole blood
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start10 May 2019
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to receive either ibuprofen or placebo after third molar extraction when pain intensity is at least 4/10. Four hours after the masked ibuprofen or placebo, all subjects will receive open-label ibuprofen + acetaminophen to be taken every 4 hours for the first 2 days and then as needed for up to 7 days after oral surgery. Oxycodone will be available as a rescue medication if additional analgesic is requested.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tilo Grosser, MD, Principal investigator, University of PennsylvaniaKatherine N Theken, PharmD, PhD, Principal investigator, University of PennsylvaniaElliot V Hersh, DMD, MS, PhD, Principal investigator, University of PennsylvaniaJohn Farrar, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893175
- Sponsor's protocol ID
- 832417
- Status last verified
- Jul 2025
- First submitted
- 22 Mar 2019
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.
PubMed 17666691Gauger EM, Gauger EJ, Desai MJ, Lee DH. Opioid Use After Upper Extremity Surgery. J Hand Surg Am. 2018 May;43(5):470-479. doi: 10.1016/j.jhsa.2018.02.026. Epub 2018 Mar 27.
PubMed 29602656Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20.
PubMed 27663358Thiels CA, Anderson SS, Ubl DS, Hanson KT, Bergquist WJ, Gray RJ, Gazelka HM, Cima RR, Habermann EB. Wide Variation and Overprescription of Opioids After Elective Surgery. Ann Surg. 2017 Oct;266(4):564-573. doi: 10.1097/SLA.0000000000002365.
PubMed 28697049Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [Internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK424857/
PubMed 28252892Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.
PubMed 26760086Cooper SA, Engel J, Ladov M, Precheur H, Rosenheck A, Rauch D. Analgesic efficacy of an ibuprofen-codeine combination. Pharmacotherapy. 1982 May-Jun;2(3):162-7. doi: 10.1002/j.1875-9114.1982.tb04528.x.
PubMed 6763202Hersh EV, Levin LM, Adamson D, Christensen S, Kiersch TA, Noveck R, Watson G 2nd, Lyon JA. Dose-ranging analgesic study of Prosorb diclofenac potassium in postsurgical dental pain. Clin Ther. 2004 Aug;26(8):1215-27. doi: 10.1016/s0149-2918(04)80033-x.
PubMed 15476903Hersh EV, Levin LM, Cooper SA, Doyle G, Waksman J, Wedell D, Hong D, Secreto SA. Ibuprofen liquigel for oral surgery pain. Clin Ther. 2000 Nov;22(11):1306-18. doi: 10.1016/s0149-2918(00)83027-1.
PubMed 11117655Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069.
PubMed 15462686
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction
- ClinicalTrials.gov ID
- NCT03893175
- Acronym / sponsor ID
- 832417
- Conditions
- Impacted Third Molar Tooth, Pain, Acute
- Keywords
- Non-steroidal anti-inflammatory drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will evaluate inter-individual variability in the analgesic response to the non-steroidal anti-inflammatory drug (NSAID) ibuprofen after third molar extraction surgery. It will also investigate demographic, clinical, genetic, and environmental factors that cause this variability.
Detailed description
The dramatic increase in opioid prescriptions over the past years has been linked to the concomitant rise in opioid addiction and to deaths from opioid abuse. Young adults' initial exposure to opioid analgesics is often following extraction of their impacted third molars, with an average of 5,000,000 cases in the USA per year. Over-prescribing of opioids for surgical pain, often 2-5 times more than patients actually use, further exacerbates this problem, as patients tend to save leftover pills rather than discard them. Up to 70% of individuals who become addicted to prescription opioids had access to leftover pills prescribed for others. This is particularly troubling as the odds of transitioning to heroin from prescription opioid abuse are much higher than other suspected gateway drugs, about 40 fold greater than non-gateway drug users. Heroin is now often laced with fentanyl derivatives making overdose and death more likely in even the most opioid tolerant individuals.
Multiple studies have demonstrated that non-addicting nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac are effective in relieving pain after dental impaction surgery, being at least equally efficacious to optimal doses of immediate release opioid formulations combined with acetaminophen. However, these assessments of pain relief represent average scores and approximately 22% and 50% of individuals required additional opioid-containing rescue analgesics when ibuprofen and diclofenac were employed at FDA-approved dosages. A deeper understanding of the sources of variability in pain relief should allow improvements in the overall efficacy of NSAIDs by targeting treatment to those who are most likely to receive sufficient pain relief. Thus, optimizing pain therapy with NSAIDs by personalization would be expected to help limit the unnecessary prescription of highly addicting immediate release opioids. Moreover, these results may have applicability to other types of pain that are driven by inflammation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive either ibuprofen or placebo after third molar extraction when pain intensity is at least 4/10. Four hours after the masked ibuprofen or placebo, all subjects will receive open-label ibuprofen + acetaminophen to be taken every 4 hours for the first 2 days and then as needed for up to 7 days after oral surgery. Oxycodone will be available as a rescue medication if additional analgesic is requested.
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen, Drug: Acetaminophen, Drug: OxycodoneDuring the double-blind stage, subjects will receive blinded ibuprofen (400 mg by mouth) when pain is at least 4/10 following third molar extraction. During the open-label stage, all subjects will receive ibuprofen (400 mg by mouth) and acetaminophen (500 mg by mouth) to be taken every 4 hours around the clock for the first 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction. Rescue medication (oxycodone 5 mg by mouth) will be available if additional analgesic is requested. |
| Placebo | Placebo comparator | Drug: Ibuprofen, Drug: Acetaminophen, Drug: Placebo, Drug: OxycodoneDuring the double-blind stage, subjects will receive blinded placebo when pain is at least 4/10 following third molar extraction. During the open-label stage, all subjects will receive ibuprofen (400 mg by mouth) and acetaminophen (500 mg by mouth) to be taken every 4 hours around the clock for the first 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction. Rescue medication (oxycodone 5 mg by mouth) will be available if additional analgesic is requested. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Men and women greater than 18 years of age requiring extraction of at least one impacted mandibular third molar tooth (at least 50% covered with bone).
- Body mass index (BMI) between 18 and 30 kg/m2.
- Absence of other major medical problems or contraindications to surgery or study drugs.
- Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening.
- Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and a urine pregnancy test on the day of surgery, which must be negative at all time points.
Key exclusion criteria (14 listed)
- Female subjects who are pregnant or nursing a child.
- Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects who are sensitive or allergic to ibuprofen, acetaminophen, or their components.
- Subjects who are sensitive or allergic to aspirin or other NSAIDs.
- Subjects who are sensitive or allergic to oxycodone or other opioids (excluding nausea and constipation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Advil400 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction | Drug | Ibuprofen, Placebo |
| AcetaminophenAlso: Tylenol500 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction | Drug | Ibuprofen, Placebo |
| PlaceboBy mouth | Drug | Placebo |
| Oxycodone5 mg by mouth every 6 hours as needed for pain | Drug | Ibuprofen, Placebo |
Primary outcome
Analgesic response
Time frame: Up to 7 days after third molar extraction
Use of opioid rescue medication
15 secondary outcomes
Ibuprofen plasma concentrations
Time frame: Up to 7 days
Acetaminophen plasma concentrations
Time frame: Up to 7 days
Gene expression profiling
Time frame: Up to 7 days
COX-1 activity
Time frame: Up to 7 days
COX-2 activity
Time frame: Up to 7 days
DNA sequencing
Time frame: 1 day
Urinary metabolomics
Time frame: Up to 7 days
Plasma metabolomics
Time frame: Up to 7 days
Composition of the gut microbiome
Time frame: 1 day
Composition of the oral microbiome
Time frame: 1 day
Pain intensity score
Time frame: Up to 7 days
Inflammatory mediator profiling
Time frame: Up to 7 days
C-reactive protein
Time frame: Up to 7 days
Procalcitonin levels
Time frame: Up to 7 days
Complete blood count with differential
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 17666691Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.
- Background: PubMed 29602656Gauger EM, Gauger EJ, Desai MJ, Lee DH. Opioid Use After Upper Extremity Surgery. J Hand Surg Am. 2018 May;43(5):470-479. doi: 10.1016/j.jhsa.2018.02.026. Epub 2018 Mar 27.
- Background: PubMed 27663358Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20.
- Background: PubMed 28697049Thiels CA, Anderson SS, Ubl DS, Hanson KT, Bergquist WJ, Gray RJ, Gazelka HM, Cima RR, Habermann EB. Wide Variation and Overprescription of Opioids After Elective Surgery. Ann Surg. 2017 Oct;266(4):564-573. doi: 10.1097/SLA.0000000000002365.
- Background: PubMed 28252892Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [Internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK424857/
- Background: PubMed 26760086Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.
- Background: PubMed 6763202Cooper SA, Engel J, Ladov M, Precheur H, Rosenheck A, Rauch D. Analgesic efficacy of an ibuprofen-codeine combination. Pharmacotherapy. 1982 May-Jun;2(3):162-7. doi: 10.1002/j.1875-9114.1982.tb04528.x.
- Background: PubMed 15476903Hersh EV, Levin LM, Adamson D, Christensen S, Kiersch TA, Noveck R, Watson G 2nd, Lyon JA. Dose-ranging analgesic study of Prosorb diclofenac potassium in postsurgical dental pain. Clin Ther. 2004 Aug;26(8):1215-27. doi: 10.1016/s0149-2918(04)80033-x.
- Background: PubMed 11117655Hersh EV, Levin LM, Cooper SA, Doyle G, Waksman J, Wedell D, Hong D, Secreto SA. Ibuprofen liquigel for oral surgery pain. Clin Ther. 2000 Nov;22(11):1306-18. doi: 10.1016/s0149-2918(00)83027-1.
- Background: PubMed 15462686Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilo Grosser, MD principal investigator
University of Pennsylvania
Katherine N Theken, PharmD, PhD principal investigator
University of Pennsylvania
Elliot V Hersh, DMD, MS, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen, Acetaminophen and Oxycodone in people with Impacted Third Molar Tooth and Pain, Acute, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic response (time frame: Up to 7 days after third molar extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03893175, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.