Summary
To compare the analgesic activity of nefopam HCl with d-propoxyphene HCl, 85 male and 40 female in-patients, between 18 and 73 years of age, suffering moderate to severe postoperative pain one to three days after operation, were assigned randomly to one of five treatment groups of 25 patients each. Two groups were given nefopam HCl, one 60 mg and the other 90 mg, while two other groups received d-propoxyphene HCl, 65 mg and 130 mg respectively. The fifth group received a placebo.
The efficacy of the drugs was assessed double blind by analyzing the pain intensity, pain intensity differences, weighted sum of pain intensity differences, pain relief and weighted total pain relief scores based on a 4-point pain intensity and 5-point pain relief scale determined 0.5, 1, 2, 3, 4, 5, and 6 hours after the administration of the medication.
The pain relief and weighted sum of pain intensity difference values were most effective in detecting differences between the active drugs and placebo. Pain intensity differences and weighted total pain relief scores were less useful in this respect. The efficacy of d-propoxyphene 130 mg and nefopam HCl 60 mg were not significantly different from one another, while each was significantly more effective than placebo. Nefopam HCl 90 mg and d-propoxyphene 65 mg and placebo were not significantly different.
Light-headedness, grogginess and drowsiness were reported more frequently for propoxyphene than for placebo; sweating, tachycardia, sleepiness and tiredness were observed more often with nefopam than with placebo. Nefopam caused a greater incidence of sweating than propoxyphene, while the latter was responsible for the more frequent occurrence of a dry mouth and light-headedness than the former.
According to this study, nefopam HCl 60 mg was as effective as d-propoxyphene HCl 130 mg in alleviating moderate to severe postoperative pain one to three days after operation.
Résumé
Ľactivité analgésique du nefopam HCl à des doses de 60 mg et 90 mg et du d-propoxyphene HCl à des doses de 65 mg et 130 mg fut comparée à celle ďun placebo chez 125 malades des deux sexes, âgés de 18 à 73 ans, qui se plaignaient de douleurs post-opératoires.
Ľétude a été faite en double-insu, pendant une période de six heures, au cours de laquelle, à une heure ďintervalle chaque fois, les paramètres suivants ont été relevés, suivant une échelle de zéro à trois (intensité douloureuse) ou de zéro à quatre (allégement de la douleur): intensités douloureuses, variations ďintensité douloureuse somme des variations ďintensité, allégements de la douleur, somme des allégements. Les paramètres allégements de la douleur et somme des variations ďintensité se montrèrent, lors de ľanalyse des résultats, plus efficaces que les variations ďintensité douloureuse et la somme des allégements dans la mise en évidence des effets des drogues analgésiques par rapport au placebo.
Les doses de 130 mg de d-propoxyphene et de 60 mg de nefopam HCl, sans pouvoir être différenciées les unes des autres, s’avérèrent plus efficaces que le placebo; par contre les effets des doses de 90 mg de nefopam HCl et de 65 mg de d-propoxyphene ne purent être distingués de ceux du placebo.
Après avoir pris du propoxyphene certains malades se plaignirent de somnolence, de perte ďéquilibre ou de concentration, tandis qu’après le nefopam les malades rapportèrent de la transpiration, de la tachycardie, de la somnolence et de la fatigue.
En conclusion, cette étude montre que des doses de 60 mg de nefopam HCl et de 130 mg de d-propoxyphene sont également efficaces pour traiter la douleur après une intervention chirurgicale.
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Trop, D., Kenny, L. & Grad, B.R. Comparison of nefopam hydrochloride and propoxyphene hydrochloride in the treatment of postoperative pain. Canad. Anaesth. Soc. J. 26, 296–304 (1979). https://doi.org/10.1007/BF03006290
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DOI: https://doi.org/10.1007/BF03006290