IngentaConnect Clinical equivalence of IV paracetamol compared to IV dipyrone fo...

Authors: Kampe, Sandra¹; Warm, Mathias²; Landwehr, Susanne¹; Dagtekin, Oguzhan¹; Haussmann, Sascha¹; Paul, Matthias¹; Pilgram, Barbara¹; Kiencke, Peter³

Source: Current Medical Research and Opinion, Volume 22, Number 10, October 2006 , pp. 1949-1954(6)

Publisher: Informa Healthcare

Abstract:

Objective: To assess clinical efficacy of IV paracetamol 1 g and IV dipyrone 1 g on a 24-h dosing schedule in this randomised, double-blinded study of 40 ASA I-III (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer.

Research design and methods: General anaesthesia using remifentanil and propofol was performed for surgery. The patients were randomly allocated to two groups, receiving infusions of paracetamol 1 g/100 mL (Para Group) or of dipyrone 1 g/100 mL (Dipy Group) 30 min before arrival in the recovery area and every 6 h up to 24 h postoperatively. All patients had unrestricted access to opioid rescue medication via an IV patient-controlled analgesia (PCA) device.

Main outcome measures: The primary variables for clinical equivalence were the differences between the mean values for pain scores at rest and pain scores on coughing over 30 h postoperatively. The equivalence margin was determined as ±10 mm on the visual analogue scale (VAS).

Results: Regarding pain scores at rest, the 90% CI of the mean differences between the treatment groups over 30 h postoperatively was found to be within the predefined equivalence margin [+7.5/−6.2], and the CI values for pain scores on coughing [+7.3/−9.0] were similar. The two groups did not differ in cumulative opioid rescue consumption (Dipy-Group 14.8 ± 17.7 mg vs. Para Group 12.1 ± 8.8 mg, p = 0.54) nor in piritramide loading dose (Dipy Group 0.95 ± 2.8 mg vs. Para Group 1.3 ± 2.8 mg, p = 0.545). Five patients in the Dipy Group experienced hypotension in contrast to none in the Para Group (p = 0.047). There were no significant between-treatment differences for other adverse events, patient satisfaction scores (p = 0.4) or quality of recovery scores (p = 0.3).

Conclusion: IV paracetamol 1 g is clinically equivalent to IV dipyrone 1 g for postoperative analgesia after surgery for breast cancer.

Keywords: ANALGESIC EFFICACY; BREAST SURGERY; DIPYRONE; PARACETAMOL; POSTOPERATIVE ANALGESIA

Document Type: Short communication

DOI: 10.1185/030079906X132659

Affiliations: 1: Department of Anaesthesiology, University of Cologne, Cologne, Germany 2: Department of Gynaecology, University of Cologne, Cologne, Germany 3: Institute of Empirical Health Economics, Burscheid, Germany

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Clinical equivalence of IV paracetamol compared to IV dipyrone for postoperative analgesia after surgery for breast cancer