@article {Kampe:October 2006:0300-7995:1949,
	author = "Kampe, Sandra",
	author = "Warm, Mathias",
	author = "Landwehr, Susanne",
	author = "Dagtekin, Oguzhan",
	author = "Haussmann, Sascha",
	author = "Paul, Matthias",
	author = "Pilgram, Barbara",
	author = "Kiencke, Peter",
	title = "Clinical equivalence of IV paracetamol compared to IV dipyrone for postoperative analgesia after surgery for breast cancer",
	journal = "Current Medical Research and Opinion",
	volume = "22",
	year = "October 2006",
	abstract = "<I>Objective:</I> 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.<P></P><I>Research design and methods:</I> 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.<P></P><I>Main outcome measures:</I> 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 &#177;10 mm on the visual analogue scale (VAS).<P></P><I>Results:</I> 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/&#8722;6.2], and the CI values for pain scores on coughing [+7.3/&#8722;9.0] were similar. The two groups did not differ in cumulative opioid rescue consumption (Dipy-Group 14.8 &#177; 17.7 mg vs. Para Group 12.1 &#177; 8.8 mg, <I>p</I> = 0.54) nor in piritramide loading dose (Dipy Group 0.95 &#177; 2.8 mg vs. Para Group 1.3 &#177; 2.8 mg, <I>p</I> = 0.545). Five patients in the Dipy Group experienced hypotension in contrast to none in the Para Group (<I>p</I> = 0.047). There were no significant between-treatment differences for other adverse events, patient satisfaction scores (<I>p</I> = 0.4) or quality of recovery scores (<I>p</I> = 0.3).<P></P><I>Conclusion:</I> IV paracetamol 1 g is clinically equivalent to IV dipyrone 1 g for postoperative analgesia after surgery for breast cancer.",
	pages = "1949-1954(6)",
	url = "http://www.ingentaconnect.com/content/apl/cmro/2006/00000022/00000010/art00011"
	doi = "doi:10.1185/030079906X132659"
}