Summary and Conclusions
Informed consent was obtained from over 350 patients scheduled for major elective operations to accept either 5 or 10 mg morphine or 0.5 or 1.0 mg butorphanol (intramuscularly) under double-blind conditions according to a random assignment schedule, if they should complain of moderate to severe pain while in the recovery room. Of those consenting, 120 patients were entered in the study. The remainder either denied any pain, stated that they had only slight or mild pain, or in a few instances, refused analgesic medication although they stated they had more than mild pain. Pain intensity and pain relief were scored for each treated patient at 30, 60 and 120 minutes. Scores were analyzed statistically after tabulating the data. The data show that in virtually all these patients appreciable pain relief was admitted at the first observation period (30 minutes after administration of the drug) and it persisted for at least two hours in 90 per cent of them. No consistent alteration in the vital signs (blood pressure, pulse rate, rate of respiration or tidal volume ) was evident in these patients during the two hours they were kept under close surveillance. Approximately 10 per cent of the patients receiving butorphanol, and 15 per cent of those receiving morphine, did not request more analgesic medication; 52 per cent (butorphanol) and 42 per cent (morphine) respectively requested additional medication two to five hours after, and 25 per cent (butorphanol) and 34 per cent (morphine), respectively, requested it only after 5 hours. Analysis by the parallel line assay method produced an estimate that butorphanol ( base weight ) was on the order of ten times more potent than morphine sulfate. Due to uncertain factors, the effect of the two doses of butorphanol tested could not be distinguished two hours after medication.
Drowsiness occurred early in one-third of the patients receiving butorphanol and usually persisted for several hours, whereas this effect was less prominent with morphine and was of shorter duration. Dizziness, nausea or emesis occurred in less than 5 per cent after either medication. If extensive experience with butorphanol shows that it is non-addicting and does not cause appreciable respiratory depression, it will indeed be a useful analgesic drug.
Résumé
Nous avons au préalable, obtenu la permission de 350 malades subissant une chirurgie élective majeure, de les inclure dans une étude comparative de deux analgesiques soit le Butorphanol et la Morphine. Us avaient accepté de recevoir Tun ou l’autre de ces médicaments en cas de douleur modérée ou importante, dans la salle de réveil, tout ceci dans le cadre d’une étude à double-insu. Les doses administrées étaient de 5 à 10 mg de Morphine ou de 0.5 mg à 1 mg de Butorphanol.
De ces 350 malades, 120 furent effectivement étudiés, ayant reçu I’un ou l’autre des médicaments à l’étude. Les autres n’ont pas présenté de douleur ou n’ont accusé qu’une douleur légère ou encore ont refusé un calmant tout en admettant une douleur plus que légère.
Chez tous ceux ayant recu I’un ou l’autre des analgésiques, l’intensité de la douleur et l’efficacité de son soulagement fut notée 30, 60 et 120 minutes apres l’administration du médicament. Les résultats ont démontré dans pratiquement tous les cas qu’il y avait soulagement appréciable de la douleur trente minutes après l’administration de Tun ou l’autre des agents et que cette analgésie persistait au moins 2 heures chez 90 pour cent d’entre eux. Pendant cette même période de 2 heures, les signes vitaux demeurerent stables (fréquence cardiaque, pression arterielle, fr équence + amplitude de la respiration ).
Environ 10 pour cent de ceux qui reçurent du Butorphanol et 15 pour cent de ceux ayant recu de la Morphine n’ont pas requis d’autre analgésique; 52 pour cent des patients ayant recu du Butorphanol et 42 pour cent des sujets a la Morphine ont reçuis une dose additionnelle de medicament entre 2 et 5 heures apres.
Enfin, 259 des malades ayant recu du Butorphanol et 34 pour cent de ceux ayant recu de la Morphine ont requis une dose supplemental plus de 5 heures apres la première administration. On estime que, poids pour poids, le Butorphanol est 10 fois plus puissant que la Morphine. Deux heures après l’administration on ne pouvait faire de distinction entre les effets des deux dosages de Butorphanol utilises. Chez environ 1/3 des patients, le Butorphanol produit de la somnolence, effet qui persiste quelques heures et semble plus marque et plus prolonge, qu’avec la Morphine. Moins de 5 pour cent malades des deux series ont presente des etourdissements, des nausees et des vomissements.
Si à l’usage, le Butorphanol ne montre pas de propriétés addictives et ne cause pas de dépression respiratoire importante, ce sera un médicament utile.
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Dobkin, A.B., Eamkaow, S., Zak, S. et al. Butorphanol: a double-blind evaluation in postoperative patients with moderate or severe pain. Canad. Anaesth. Soc. J. 21, 600–610 (1974). https://doi.org/10.1007/BF03006021
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DOI: https://doi.org/10.1007/BF03006021