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Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study.

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-?g 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.

SUBMITTER: Ringold FG

PROVIDER: S-EPMC4272222 | biostudies-literature | 2015 Jan-Feb

REPOSITORIES: biostudies-literature

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Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study.

Ringold Forrest G FG Minkowitz Harold S HS Gan Tong Joo TJ Aqua Keith A KA Chiang Yu-Kun YK Evashenk Mark A MA Palmer Pamela P PP

Regional anesthesia and pain medicine 20150101 1

<h4>Background and objectives</h4>This study evaluates the efficacy and safety of a sufentanil sublingual tablet system (SSTS) for the management of postoperative pain following open abdominal surgery.<h4>Methods</h4>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 dispens ...[more]

PMID: 25318408

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Project description:ObjectiveTo evaluate sufentanil sublingual tablet 30 mcg (SST 30 mcg) for postoperative pain in an older patient population with comorbidities.DesignMulticenter, open-label, single-arm study.SettingNine hospitals across the United States.SubjectsAdults aged ≥40 years who had undergone a surgical procedure.MethodsPatients with a postoperative pain intensity score ≥4 on an 11-point numeric rating scale (NRS) were allowed to enter the study and receive SST 30 mcg as requested for pain (minimum 60-minute redosing interval) over the 12-hour study period. Efficacy was assessed by patient reports of pain intensity on the NRS and a five-point pain relief scale. Safety was monitored throughout the study; plasma sufentanil concentrations were also measured. The primary efficacy endpoint was the time-weighted summed pain intensity difference (SPID) to baseline over 12 hours (SPID12).ResultsOf the 140 patients enrolled, 69% were American Society of Anesthesiologists Physical Class II or III, 44% had a body mass index (BMI) ≥30 mg/kg2, and 29% had hepatic and/or renal impairment. Average age was 54.7 years (SD = 9.9 years), and average baseline pain intensity was 6.2 (SD = 1.9). The most common surgeries were abdominal (59%) and orthopedic (20%). The mean SPID12 was 36.0 (standard error of the mean = 2.2); mean scores were similar, regardless of age, sex, race, and BMI. From baseline, mean pain intensity decreased significantly starting 30 minutes postdose, and mean pain relief increased significantly starting 15 minutes postdose, remaining relatively stable through 12 hours (P < 0.001 at each time point). Four (3%) patients discontinued due to inadequate analgesia, and 45 (32%) patients had one or more adverse events that were considered possibly or probably related to the study drug. Mean plasma sufentanil concentrations were generally similar regardless of age, sex, BMI, or organ impairment status.ConclusionsSST 30 mcg was effective and well tolerated for the management of moderate-to-severe acute postoperative pain.

Project description:BackgroundFollowing abdominal surgery, postoperative ileus is a common complication significantly increasing patient morbidity and cost of hospital admission. This is the first systematic review aimed at determining the average global hospital cost per patient associated with postoperative ileus.MethodsA systematic search of electronic databases was performed from January 2000 to March 2023. Studies included compared patients undergoing abdominal surgery who developed postoperative ileus to those who did not, focusing on costing data. The primary outcome was the total cost of inpatient stay. Risk of bias was assessed using the Newcastle-Ottawa assessment tool. Summary meta-analysis was performed.ResultsOf the 2071 studies identified, 88 papers were assessed for full eligibility. The systematic review included nine studies (2005-2022), investigating 1 860 889 patients undergoing general, colorectal, gynaecological and urological surgery. These studies showed significant variations in the definition of postoperative ileus. Six studies were eligible for meta-analysis showing an increase of €8233 (95 per cent c.i. (5176 to 11 290), P < 0.0001, I2 = 95.5 per cent) per patient with postoperative ileus resulting in a 66.3 per cent increase in total hospital costs (95 per cent c.i. (34.8 to 97.9), P < 0.0001, I2 = 98.4 per cent). However, there was significant bias between studies. Five colorectal-surgery-specific studies showed an increase of €7242 (95 per cent c.i. (4502 to 9983), P < 0.0001, I2 = 86.0 per cent) per patient with postoperative ileus resulting in a 57.3 per cent increase in total hospital costs (95 per cent c.i. (36.3 to 78.3), P < 0.0001, I2 = 85.7 per cent).ConclusionThe global financial burden of postoperative ileus following abdominal surgery is significant. While further multicentre data using a uniform postoperative ileus definition would be useful, reducing the incidence and impact of postoperative ileus are a priority to mitigate healthcare-related costs, and improve patient outcomes.

Project description:Background Intravenous paracetamol added to morphine reduces postoperative morphine consumption in (near)term neonates. However, there are only sparse data on intravenous paracetamol as multimodal strategy in extremely low birth weight (ELBW) neonates. Objectives This study aims to assess the effects of rescue intravenous paracetamol on postoperative pain management (≤48 h postoperatively) in relation to both analgesic efficacy (validated pain assessment, drug consumption, adequate rescue medication) and safety (hypotension and bradycardia). This rescue practice was part of a standardized pain management approach in a single neonatal intensive care unit (NICU). Methods A single-center retrospective observational study included 20 ELBW neonates, who underwent major abdominal surgery. The primary endpoints of the postoperative study period were pain intensity, over-sedation, time to first rescue analgesic dose, and the effect of paracetamol on opiate consumption. Secondary endpoints were safety parameters (hypotension, bradycardia). And as tertiary endpoints, the determinants of long-term outcome were evaluated (i.e., duration of mechanical ventilation, intraventricular hemorrhage - IVH, periventricular leukomalacia - PVL, postnatal growth restriction, stage of chronic lung disease – CLD or neurodevelopmental outcome according to Bayley-II Scales of Infant Development at 18–24 months). Results All neonates received continuous opioids (sufentanil or morphine) and 13/20 also intravenous paracetamol as rescue pain medication during a 48-h postoperative period. Although opioid consumption was equal in the non-paracetamol and the paracetamol group over 48 h, the non-paracetamol group was characterized by oversedation (COMFORTneo < 9), a higher incidence of severe hypotension, and younger postnatal age (p < 0.05). All long-term outcome findings were similar between both groups. Conclusions Our study focused on postoperative pain management in ELBW neonates, and showed that intravenous paracetamol seems to be safe. Prospective validation of dosage regimens of analgesic drugs is needed to achieve efficacy goals.

Dataset Information

Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study.

Publications

Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study.

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