The goal of the present phase IIb clinical trial was to compare the safety and efficacy of the fixed-dose combination etoricoxib-tramadol 120mg/100mg tablet (once a day, for three days) versus naproxen 220mg tablet plus tramadol 50 mg capsule in patients with acute postoperative pain after impacted third molar extraction. The main research question was: Is the analgesic efficacy of etoricoxib-tramadol 120mg/100mg tablet non-inferior to naproxen 220 mg tablet + tramadol 50 mg capsule in a clinical model of moderate to severe acute pain? After informed consent, patients were randomly assigned to one of the two arms: test product (etoricoxib-tramadol 120mg/100mg tablet) or active comparator (naproxen 220mg tablet + tramadol 50 mg capsule). After surgery, patients were requested to start the treatment with study drugs (test product was administered once daily for three days; meanwhile reference drug was administered twice a day for three days). Investigators compared the effects of both treatments on pain intensity at different time frames using the visual analogue scale. Furthermore, the safety of investigational drugs was assessed during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Oaxaca Site Management Organization
Oaxaca City, Mexico
Pain intensity difference (PID)
The difference in pain intensity at 4 h after drug administration versus time 0 (baseline, before dosing)
Time frame: At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)
Pain intensity difference (PID)
The difference in pain intensity at 1, 2, 3, 6, 12, 24, 48, and 72 hours after drug administration versus time 0 (baseline, before dosing)
Time frame: At 1, 2, 3, 6, 12, 24, 48, and 72 hours postdosing respecto the baseline (Day 0, before dosing)
Total pain relief (TOTPAR)
TOTPAR is a time-weighted measure of AUC or total area under the pain relief curve and is a summary measure that integrates serial assessments of a subject's pain over the duration of the study or in any time frime.
Time frame: At 4, 6, 12, 24, 48, 72 hours postdosing respect to the baseline (Day 0, before dosing)
Trismus control
Measurement the difference of mouth opening (in mm) at baseline (before dosing) and at the end of the study (Day 7).
Time frame: At the end of the study (Day 7) respect to the baseline (Day 0, before dosing)
Adverse events
Characteristics and frequency of adverse events
Time frame: From informed consent (Day -28) to the end of the study (Day 7)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.