Comparative trial of tramadol/paracetamol and codeine/paracetamol combination tablets on the vigilance of healthy volunteers

Abstract

Combination of tramadol 37.5 mg/paracetamol 325 mg (a), or codeine 30 mg/paracetamol 500 mg (b) or 300 mg have similar pain efficacy but a difference has been suggested concerning their adverse events on vigilance. In clinical practice, combinations are usually given at the above-mentioned dosage three to four times a day. The aim of this study was to compare a single dose of these two combinations (a) and (b) in 24 healthy young volunteers on visual choice reaction time (CRT, ms). Results show a longer CRT (P < 0.05) (up to 4% of the control value 3 h post-dosing) and a higher report of somnolence in the codeine/paracetamol group compared with tramadol/paracetamol group (50% vs. 4% of the subjects). This observation is important and proves that even a single dosage of these largely used drugs may have a significant effect. This finding should be further investigated in elderly subjects who consume largely these drugs for chronic pain alleviation and who are more prone to this kind of adverse event.

Impairment based legislative limits for driving under the influence of non-alcohol drugs in Norway

“…Codeine is metabolised to morphine in the body, and pain studies suggest that the analgesic effect from codeine is caused by morphine. Experimental studies have shown impairment in traffic related tests, but concentrations of morphine and codeine in blood have not been measured in these studies [6][7][8][9][10]. Codeine was therefore not included on the list on the assumption that morphine levels will identify cases where codeine, morphine, or heroin have been used.…”

Tramadol/paracetamol fixed-dose combination in the treatment of moderate to severe pain

“…However, there are few direct comparative studies of combination products – for instance, codeine/paracetamol versus tramadol/paracetamol 131–133…”

Pro–con debate: is codeine a drug that still has a useful role in pediatric practice?

“…Adult data from postoperative orthopedic pain suggest similar pain scores for tramadol–paracetamol compared to codeine–paracetamol, although the incidence of constipation and vomiting was higher in those given codeine (68). Other data suggest increased somnolence in adults given codeine over tramadol (69); although this may not necessarily be a bad thing in children.…”