TITLE:
Randomized, Double Blind, Double-Masked, Parallel-Group Clinical Study to Compare the Effectiveness of Oral Transmucosal Fentanyl 200 µg vs Morphine Hydrochloride 2 mg IV in the Treatment of Postoperative Pain
AUTHORS:
Hernan Figueredo, Vicente Bozza, Maria Gonzalez Yibirin, David Alberto Rincón Matute
KEYWORDS:
Postoperative Pain, VAS, PR, PID, SPID, TOTPAR, Fentanyl, Morphine
JOURNAL NAME:
Open Journal of Anesthesiology,
Vol.15 No.2,
February
28,
2025
ABSTRACT: Postoperative pain is an acute pain that appears due to the surgical act, reaching its maximum intensity in the first 24 - 48 hours after surgery. Postoperative pain control reduces possible postoperative complications, as well as the patient’s stay in the medical institution. Objective: This study compared the effectiveness and side effects of oral transmucosal fentanyl citrate (OTFC) with IV morphine in the control of postoperative pain. Methods: Seventy-three patients (Fentanyl group: 27, morphine group: 46) were included. Changes in pain were evaluated with Visual Analog Scale (VAS) and Pain Relief Scale, Pain Intensity Differences (PID), Sum of Pain Intensity Differences (SPID), and Total Pain Relief (TOTPAR). At time zero, 15, 30, 45 min and 1, 2, 3, 4, 5 and 6 h. Results: The decrease in pain intensity measured by VAS was similar in both groups with no significant differences at any of the measurement points. Both products produced a significant increase in the Pain Relief scale, with no differences between groups at any of the measurement times. There were no differences between groups when comparing PID. Comparing SPID between groups, there were no differences at 15, 30 minutes, then there were significant differences in favor of the Fentanyl group up to 6 hours. Both products produced a significant increase in the TOPAR scale, with no differences between groups at any of the measurement times. The appearance of adverse effects was similar in both groups. Conclusions: Both products produced a significant reduction in the measures of pain intensity (VAS), increase of SPID, as well as a significant increase in the Pain Relief scale, a significant increase in the TOPAR scale, with no differences between the groups. The number of adverse effects was similar. The convenience of OTFC administration allows its administration without the special conditions needed for the administration of IV morphine.