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Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.

ABSTRACT: Problems with intravenous patient-controlled analgesia (IV PCA) are well known, including invasive route of delivery and pump programming errors. The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system (sufentanil sublingual tablet system 15 mcg with a 20-minute lockout interval; SSTS) to IV PCA morphine sulfate 1 mg with a 6-minute lockout interval (IV PCA MS) for the management of acute postoperative pain.This was a randomized, open-label, 48-hour non-inferiority study with optional extension to 72 hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic (hip or knee replacement) surgery. The primary outcome measure was the proportion of patients who responded "good" or "excellent" (collectively "success") at the 48-hour timepoint on the Patient Global Assessment of method of pain control (PGA48).A total of 357 patients received study drug and 78.5% vs. 65.6% of patients achieved PGA48 "success" for SSTS vs. IV PCA MS, respectively, demonstrating non-inferiority (P < 0.001 using the one-side Z-test against the non-inferiority margin) as well as statistical superiority for treatment effect (P = 0.007). Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups; however, SSTS had fewer patients experiencing oxygen desaturations below 95% compared to IV PCA MS (P = 0.028).Sufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA.

SUBMITTER: Melson TI

PROVIDER: S-EPMC4234007 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.

Melson Timothy I TI Boyer David L DL Minkowitz Harold S HS Turan Alparslan A Chiang Yu-Kun YK Evashenk Mark A MA Palmer Pamela P PP

Pain practice : the official journal of World Institute of Pain 20140825 8

<h4>Background</h4>Problems with intravenous patient-controlled analgesia (IV PCA) are well known, including invasive route of delivery and pump programming errors. The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system (sufentanil sublingual tablet system 15 mcg with a 20-minute lockout interval; SSTS) to IV PCA morphine sulfate 1 mg with a 6-minute lockout interval (IV PCA MS) for the management of acute postoperative pain.<h4>Met ...[more]

PMID: 25155134

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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:BackgroundIntravenous morphine (IVM) is the most common strong analgesic used in trauma, but is associated with a clear time limitation related to the need to obtain an access route. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of first-pass metabolism. We aimed to determine whether IN sufentanil (INS) for patients presenting to an emergency department with acute severe traumatic pain results in a reduction in pain intensity non-inferior to IVM.Methods and findingsIn a prospective, randomized, multicenter non-inferiority trial conducted in the emergency departments of 6 hospitals across France, patients were randomized 1:1 to INS titration (0.3 μg/kg and additional doses of 0.15 μg/kg at 10 minutes and 20 minutes if numerical pain rating scale [NRS] > 3) and intravenous placebo, or to IVM (0.1 mg/kg and additional doses of 0.05 mg/kg at 10 minutes and 20 minutes if NRS > 3) and IN placebo. Patients, clinical staff, and research staff were blinded to the treatment allocation. The primary endpoint was the total decrease on NRS at 30 minutes after first administration. The prespecified non-inferiority margin was -1.3 on the NRS. The primary outcome was analyzed per protocol. Adverse events were prospectively recorded during 4 hours. Among the 194 patients enrolled in the emergency department cohort between November 4, 2013, and April 10, 2016, 157 were randomized, and the protocol was correctly administered in 136 (69 IVM group, 67 INS group, per protocol population, 76% men, median age 40 [IQR 29 to 54] years). The mean difference between NRS at first administration and NRS at 30 minutes was -4.1 (97.5% CI -4.6 to -3.6) in the IVM group and -5.2 (97.5% CI -5.7 to -4.6) in the INS group. Non-inferiority was demonstrated (p < 0.001 with 1-sided mean-equivalence t test), as the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of -1.3. INS was superior to IVM (intention to treat analysis: p = 0.034), but without a clinically significant difference in mean NRS between groups. Six severe adverse events were observed in the INS group and 2 in the IVM group (number needed to harm: 17), including an apparent imbalance for hypoxemia (3 in the INS group versus 1 in the IVM group) and for bradypnea (2 in the INS group versus 0 in the IVM group). The main limitation of the study was that the choice of concomitant analgesics, when they were used, was left to the discretion of the physician in charge, and co-analgesia was more often used in the IVM group. Moreover, the size of the study did not allow us to conclude with certainty about the safety of INS in emergency settings.ConclusionsWe confirm the non-inferiority of INS compared to IVM for pain reduction at 30 minutes after administration in patients with severe traumatic pain presenting to an emergency department. The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations. Confirmation of the safety profile of INS will require further larger studies.Trial registrationClinicalTrials.gov NCT02095366. EudraCT 2013-001665-16.

Project description:ObjectiveTo explore the effect of genetic polymorphisms of cytokines on the dosage of sufentanil for patient-controlled intravenous analgesia (PCIA) after radical lung cancer surgery.MethodsA total of 100 patients, aged 18 years and above, with ASA grade Ⅰ-Ⅱ and body mass index (BMI) 18.5 to 30, and who were scheduled for radical lung cancer surgery under total intravenous anaesthesia with PCIA of sufentanil from September 2015 to March 2016, were selected. DNA was collected from peripheral blood samples before surgery, and the iMLDRTM multiple single-nucleotide polymorphism typing kit was used to detect 16 related single-nucleotide polymorphism (SNP) sites of interleukin-1A (IL-1A), interleukin-1β (IL-1β), interleukin-1RN (IL-1RN), interleukin-6 (IL-6), C-X-C motif chemokine ligand 8 (CXCL8), interleukin-10 (IL-10), tumour necrosis factor (TNF), nuclear factor kappa-B1 (NFκB1), REL (REL proto-oncogene, NF-kB subunit), and nuclear factor kappa-B inhibitor alpha (NFκBIA). The general characteristics of patients, surgery and anaesthesia data, postoperative resting VAS pain scores, postoperative opioid dosages of sufentanil for PCIA and opioid-related adverse events were recorded. The effects of the examined genetic polymorphisms of the cytokines on the dosage of sufentanil were analysed.ResultsEight of 100 patients withdrew for various reasons, and, eventually, 92 patients were included. The patients' resting visual analogue scale (VAS) scores at 24 h, 48 h, and 72 h after surgery were 2.3 ± 1.2, 2.0 ± 0.9, and 1.9 ± 1.0, respectively. The total amounts of sufentanil used were 34.7 ± 10.5 μg, 65.2 ± 13.7 μg, and 94.7 ± 11.6 μg, respectively. We found that the TT genotype of NFκBIA rs696 had higher PCIA sufentanil dosages than the CC genotype and the CT genotype at 48-72 h postoperation (p=0.023, p=0.025, respectively).ConclusionThe genetic polymorphisms of the cytokine NFκBIA rs696 might affect the dosage of sufentanil for PCIA after radical lung cancer surgery. The specific mechanism needs further study.

Project description:BackgroundTo compare the postoperative analgesic effect of propofol total intravenous anaesthesia (TIVA) versus inhalational anaesthesia (GAS) in patients using morphine patient-controlled analgesia (PCA).MethodsA retrospective cohort study was performed in a single tertiary university hospital. Adult patients who used PCA morphine after general anaesthesia across 15 types of surgeries were included. Patients who received propofol TIVA were compared to those who had inhalational anaesthesia. Primary outcomes assessed were postoperative numerical rating scale (NRS) pain scores and postoperative opioid consumption.ResultsData from 4202 patients were analysed. The overall adjusted NRS pain scores were significantly lower in patients who received propofol TIVA at rest (GEE: β estimate of the mean on a 0 to 10 scale = -0.56, 95% CI = (-0.74 to -0.38), p < 0.001; GAS as reference group) and with movement (β estimate = -0.89, 95% CI = (-1.1 to -0.69), p < 0.001) from postoperative days (POD) 1-3. Propofol TIVA was associated with lower overall adjusted postoperative morphine consumption (β estimate = -3.45, 95% CI = (-4.46 to -2.44), p < 0.001). Patients with propofol TIVA had lower adjusted NRS pain scores with movement for hepatobiliary/pancreatic (p < 0.001), upper gastrointestinal (p < 0.001) and urological surgeries (p = 0.005); and less adjusted postoperative morphine consumption for hepatobiliary/pancreatic (p < 0.001), upper gastrointestinal (p = 0.006) and urological surgeries (p = 0.002). There were no differences for other types of surgeries.ConclusionPropofol TIVA was associated with statistically significant, but small reduction in pain scores and opioid consumption in patients using PCA morphine. Subgroup analysis suggests clinically meaningful analgesia possibly for hepatobiliary/pancreatic and upper gastrointestinal surgeries.Trial registrationThis study is registered at ClinicalTrials.gov ( NCT03875872 ).

Dataset Information

Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.

Publications

Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.

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