Fixed Dose Combination of COdeine + DIpyrone to Mitigate Moderate to Intense Pain Post-impacted T… (NCT04972292) | Clinical Trial Compass
CompletedPhase 3
Fixed Dose Combination of COdeine + DIpyrone to Mitigate Moderate to Intense Pain Post-impacted Third Lower Molar Extraction
Brazil288 participantsStarted 2023-11-08
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 30 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 dipyrone or to other pirazolones or pirazolidines (e.g.: phenazone, propyphenazone, isopropylaminophenazone, phenylbutazone, oxyphenbutazone), including history of previous agranulocytosis with one of these substances;
âś•. Known hypersensitivity to codeine or to other opioid agents;
✕. Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;
âś•. Bone marrow function impairment (e.g.: after cytostatic treatment) or hematopoietic system diseases;
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;