Abstract
Purpose
To assess the safety and efficacy of transoermal fentanyl plus im ketorolac vs im ketorolac alone in the treatment of postoperative pain.
Methods
Ninety-two patients scheduled for surgery involving moderate to severe postoperative pain were randomized to one of two groups. Group A (n=46) received an active fentanyl patch and group P (n=46) received a placebo patch. Patches remained in place for 24 hr. Each patient received intraoperative ketorolac, 60 mgim. Patients were monitored for 36 hr postoperatively and the groups were analyzed for ketorolac usage, pain scores. vital signs, serum fentanyl concentrations, and adverse events. Intramuscular ketorolac was available on demand.
Results
Group A had lower pain scores at 8, 12, 16 and 24 hr after patch placement (P< 0.05). Group A had lower heart rates, lower respiratory rates and fewer dropouts due to inadequate pain relief (4.3% vs 21.7%, P< 0.05). Group A patients also used less ketorolac than group P patients (P< 0.05). The incidence of pruntus was higher in group A patients (19%vs 2%, P< 0.05), while the incidence of nausea and vomiting was not different between the two groups. Transdermal fentanyl was adequate “stand-alone” analgesia in only 23.8% of group A patients while 93.7% of the remaining group A patients receiving a combination of transdermal fentanyl and ketorolac had adequate pain relief.
Conclusion
The transdermal fentanyl delivery system plus ketorolacim was more effective in controlling postoperative pain than ketorolacim alone. The two treatment modalities were comparable in safety with no difference in serious adverse events.
Résumé
Objectif
Évaluer en rapport avec le traitement de la douleur postopératoire la sécurité et l’efficacité du fentanyl transdermique associé au kétorolac avec celles du kétorolac seul.
Méthodes
Quatre-vingt-douze patients programmés pour une chirurgie comportant des douleurs postopératoires modérées à graves étaient répartis aléatoirement entre deux groupes. Le groupe A (n = 46) recevait un timbre autocollant au fentanyl et le groupe P (n=46) un timbre placebo. Les timbres demeuraient en place pendant 24 h. Chaque patient recevait 60 mg de kétorolacim pendant l’intervention. Les patients étaient gardés sous surveillance pendant 36 h après l’intervention et la dose de kétorolac utilisée, les scores de douleur, les signes vitaux, les concentrations de fentanyl et les incidents indésirables étaient notés. Du kétorolac était administréim sur demande.
Résultats
Les patients du groupe A présentaient les scores de douleur les plus bas à 8, 12. 16 et 24 h après l’application du timbre (P< 0.05). Les patients du groupe A avaient la fréquence cardiaque et respiratoire la plus lente et le moins de décrochage par insatisfaction (4,3%vs 21,7%$, P< 0,05). Les patients du groupe A ont aussi utilisé moins de kétorolac que ceux du groupe P (P< 0.05). Lincidence de prurit était plus élevée chez les patients du groupe A (19% vs 2%. (P< 0.05), alors que l’incidence des nausées et des vomissements était la même dans les deux groupes. Le fentanyl transdermique n’était suffisant comme analgésique unique que dans seulement 23,8% des patients du groupe A; 93.7% des autres patients du groupe A qui avaient reçu une combinaison de fentanyl transdermique et de kétorolac étaient suffisamment soulagés.
Conclusions
L’administration transdermique de fentanyl associé au kétorolacim a été plus efficace pour soulager la douleur que le kétorolacim seul. Sous l’aspect de la sécunté et des incidents indésirables, les deux méthodes étaient comparables.
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Reinhart, D.J., Goldberg, M.E., Roth, J.V. et al. Transdermal fentanyl system plusim ketorolac for the treatment of postoperative pain. Can J Anaesth 44, 377–384 (1997). https://doi.org/10.1007/BF03014457
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DOI: https://doi.org/10.1007/BF03014457