ABSTRACT
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.
Subject(s)
Abdomen/surgery , Analgesia, Patient-Controlled/methods , Analgesics, Opioid/administration & dosage , Pain Management/methods , Pain, Postoperative/prevention & control , Sufentanil/administration & dosage , Administration, Sublingual , Adult , Aged , Aged, 80 and over , Digestive System Surgical Procedures/adverse effects , Double-Blind Method , Female , Humans , Male , Middle Aged , Pain, Postoperative/diagnosis , Tablets , Young AdultABSTRACT
BACKGROUND: This study examines the effect of weight loss following laparoscopic Roux-en-Y gastric bypass (RYGBP) for morbid obesity on prescription drug costs in patients over the age of 54. METHODS: 78 patients aged 55 to 75 who met the inclusion criteria were identified in a database of 1,060 morbidly obese patients undergoing LRYGBP between March 2001 and March 2003. All prescription drugs and dosages were recorded preoperatively and postoperatively at 6 months, 1 year, and yearly thereafter. Drug history was obtained from the patient and verified by records from referring physicians' offices. The cost of a 30-day supply of each drug was obtained from 3 retail sources and averaged. RESULTS: The average pre-LRYGBP cost of prescription drugs was $368.65 per month per patient. The average annualized cost at 6 months after LRYGBP was $119.10 per month (down 68%), at 1 year $118.67 (down 68%) and at 2 years $104.68 per month (down 72%). CONCLUSIONS: Weight loss resulting from LRYGBP significantly reduces obesity-related morbidities, resulting in a substantial reduction in medication needs in patients over the age of 54. The projected cost savings realized in the 78 patients in this study amounts to approximately $240,566.04 annually.
