Oxycodone plus ibuprofen takes on codeine plus paracetamol for dental pain
NCT ID NCT05081102
First seen Sep 25, 2026 · Last updated Sep 25, 2026
Summary
Researchers are testing whether a combination of oxycodone and ibuprofen relieves moderate to intense pain after impacted wisdom tooth removal as well as a standard combination of codeine and paracetamol. The trial enrolls 288 people aged 16 to 35 in Brazil who are having a lower wisdom tooth surgically removed. Participants receive one of the two combinations, and they rate their pain relief over six hours to see how well each works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a fixed-dose combination of oxycodone and ibuprofen
- What this could lead to
- If it works, this combination could offer another option for short-term pain relief after dental surgery.
- What could go wrong
- The trial only tests one type of dental pain in young adults in Brazil, so the results may not apply to other surgeries or patients. Opioid-containing painkillers also carry risks of nausea, drowsiness, and dependence.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
288 people
The number who actually took part.
- Started
-
Mar 2024
- Finished
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Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 to 35 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged between 16 and 35 years old (inclusive). 2. Presence of impacted third lower molar with surgical removal indicated (diagnosed via panoramic x-ray within six \[6\] months before inclusion in the study), at vertical, mesioangular or horizontal position as per the Winter's classification, provided that it belongs to the following Pell \& Gregory's classes. 3. Maximum surgery duration of 40 minutes, counted from the initial incision to the impacted third molar extraction. 4. Moderate to intense postoperative pain (≥ 40 mm at a VAS of 0-100 mm) up to four (4) hours after the end of the surgery (counted from the end of the suture). 5. Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure Exclusion Criteria: 1. Known hypersensitivity to oxycodone or other opioid agents. 2. Known hypersensitivity to ibuprofen, acetylsalicylic acid (ASA), or any other non-steroidal anti-inflammatory drug (NSAID). 3. Known hypersensitivity to paracetamol or to any component of the Tylex® formulation; 4. History of bronchospasm or other anaphylactoid reactions (e.g.: hives, rhinitis, angioedema) associated with the use of analgesics, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen; 5. Abuse of illegal drugs, including alcoholism; emotional instability and/or previous attempt of suicide; 6. Pregnancy or breastfeeding. 7. Women of childbearing potential who do not agree to use a known effective birth control method, unless the participants are surgically sterile or state they are expressly free of the risk of getting pregnant for not having sexual intercourse or for having sexual intercourse with no reproductive potential. 8. Known hepatic or renal failure. 9. Participation in a clinical research protocol within the past 12 months, unless the investigator considers that the participation in the study could result in a direct benefit to the subject. 10. Presence of any condition that, in the investigator's opinion, would make the subject ineligible to participate in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Eurofarma Laboratorios S.A
São Paulo, São Paulo, 06696-000, Brazil
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