Analgesia with paracetamol/tramadol vs. paracetamol/codeine in one day-surgery: a randomized open study
Abstract
OBJECTIVES: The analgesic efficacy of two fixed combinations of tramadol/paracetamol (TP 37.5/325 mg) and codeine/paracetamol (CP 30/500 mg) was compared in 122 patients undergoing one-day surgical procedures (hallux valgus, haemorrhoidectomy, varicectomy and inguinal hernia repair), randomly treated with TP 37.5/325 mg or CP 30/500 mg one tablet after surgery ended, followed by one tablet four times daily for 48 hours.
METHODS: Pain was assessed by a Verbal Rating Scale (VRS). Whenever the VRS score was > or = 3, the patient was given a "rescue medication" (tramadol 50 mg s.c.). The quality of life (time to return to normal daily activities, nightly rest, appetite, mood, deambulation, and self-care) was assessed in the postoperative period. Patients were asked to give their judgment on the surgical procedure and postoperative outcome.
RESULTS: The results indicate that TP 37.5/325 mg was superior to CP 30/500 mg in terms of higher analgesic efficacy (VSR at 24 hours: CP 30/500, 2.52 +/- 0.86 vs. TP 37.5/325, 1.40 +/- 0.76; p < 0.001), less patients reporting adverse events (CP 30/500: 62% vs. TP 37.5/325: 36%; p < 0.01), less patients requiring rescue medications (CP 30/500: 18.2% vs. TP 37.5/325: 5.5%; p < 0.01), and more favorable judgment (scored "excellent" by 16% and 54.5% of CP 30/500 or TP 37.5/325-treated patients, respectively; p < 0.001).
CONCLUSIONS: We conclude that a fixed association of tramadol/paracetamol is a valuable and safe tool for pain management in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 122 participants or records.
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