Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study
| Autor: | Pamela P. Palmer, Forrest G. Ringold, Tong J. Gan, Keith A. Aqua, Yu-Kun Chiang, Harold S. Minkowitz, Mark A. Evashenk |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Sufentanil Placebo-controlled study Administration Sublingual Placebo law.invention Young Adult Randomized controlled trial Double-Blind Method law Abdomen Clinical endpoint medicine Humans Pain Management Digestive System Surgical Procedures Aged Aged 80 and over Pain Postoperative business.industry Analgesia Patient-Controlled General Medicine Original Articles Middle Aged Surgery Clinical trial Analgesics Opioid Anesthesiology and Pain Medicine medicine.anatomical_structure Anesthesia Female business medicine.drug Abdominal surgery Tablets |
| Zdroj: | Regional Anesthesia and Pain Medicine |
| ISSN: | 1532-8651 |
| Popis: | Background and Objectives This study evaluates the efficacy and safety of a sufentanil sublingual tablet system (SSTS) for the management of postoperative pain following open abdominal surgery. Methods At 13 hospital sites in the United States, patients following surgery with pain intensity of greater than 4 on an 11-point numerical rating scale were randomized to receive SSTS dispensing a 15-μg sufentanil tablet sublingually with a 20-minute lockout or an identical system dispensing a placebo tablet sublingually. Pain intensity scores were recorded at baseline and for up to 72 hours after starting study drug. The primary end point was time-weighted summed pain intensity difference (SPID) over 48 hours. Secondary end points included SPID and total pain relief (TOTPAR) for up to 72 hours and patient and health care provider global assessments of the method of pain control. Results Summed pain intensity difference over 48 hours was significantly higher in the SSTS group than in the placebo group (least squares mean [SEM], 105.60 [10.14] vs 55.58 [13.11]; P = 0.001). Mean SPID and TOTPAR scores were significantly higher in the SSTS group at all time points from 1 hour (SPID) or 2 hours (TOTPAR) until 72 hours (P < 0.05). In the SSTS group, patient global assessment and health care provider global assessment ratings of good or excellent were greater than placebo at all time points (P < 0.01). Safety parameters, including adverse events and vital signs, were similar for SSTS and placebo. Conclusions These results suggest that SSTS is effective and safe for the management of postoperative pain in patients following open abdominal surgery. |
| Databáze: | OpenAIRE |
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