Oxycodone plus ibuprofen takes on codeine plus paracetamol for dental pain

NCT ID NCT05081102

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Pain

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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