Fixed-dose Combination of Oxycodone [OXIcodona] + IbuproFEN in Pain Relief After Third Molar Extr… (NCT05081102) | Clinical Trial Compass
CompletedPhase 3
Fixed-dose Combination of Oxycodone [OXIcodona] + IbuproFEN in Pain Relief After Third Molar Extraction
Brazil288 participantsStarted 2024-03-27
Plain-language summary
A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil) .
Who can participate
Age range16 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Aged between 16 and 35 years old (inclusive).
âś“. 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.
âś“. Maximum surgery duration of 40 minutes, counted from the initial incision to the impacted third molar extraction.
✓. 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).
âś“. Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure
Exclusion criteria
âś•. Known hypersensitivity to oxycodone or other opioid agents.
âś•. Known hypersensitivity to ibuprofen, acetylsalicylic acid (ASA), or any other non-steroidal anti-inflammatory drug (NSAID).
✕. Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;
âś•. 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;
âś•. Abuse of illegal drugs, including alcoholism; emotional instability and/or previous attempt of suicide;
âś•. 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.