Dataset Information

Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery.

ABSTRACT:

Context

Patient-controlled analgesia (PCA) is commonly used for postoperative pain control. Although widely used, intravenous (IV) morphine PCA may not be suitable for all patients. Sufentanil sublingual tablet system (SSTS) PCA is a recent technique that has had success as a safe and effective alternative for acute pain management.

Aims

This study aims to compare both the efficacy and safety of SSTS PCA versus IV morphine PCA in postoperative pain control and the quality of recovery in adult patients following scheduled gynecological or orthopedic surgery.

Settings and design

Open-label, parallel-group, randomized controlled trial with 54 patients. The primary outcome was postoperative pain control, while the secondary outcomes included adverse effects associated with two analgesic modalities, total opioid dose required, patient satisfaction, and impact on the quality of postoperative recovery.

Methods and material

Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 26.0 (Released 2019; IBM Corp., Armonk, New York, United States). The chi-squared test was used in categorical variables. When distribution was normal, T-student (mean ± standard deviation) was used in continuous variables. In contrast, when distribution was not normal, the Mann-Whitney test (median (minimal-maximal)) was used.

Results

The results showed that there was a statistically significant difference in the total dose of opioid used by patients at 24 hours postoperatively, with patients receiving SSTS PCA requiring a higher total dose when compared to those receiving IV morphine PCA. However, there were no statistically significant differences in pain scores, adverse events, or patient satisfaction.

Conclusions

The study suggests that both IV morphine and sublingual sufentanil are safe and effective for postoperative pain management.

SUBMITTER: Fernandes DL

PROVIDER: S-EPMC10657160 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery.

Fernandes Diana L DL Pereira Ana Isabel G AIG Amorim Ana A Freitas Joana J

Cureus 20231019 10

<h4>Context</h4>Patient-controlled analgesia (PCA) is commonly used for postoperative pain control. Although widely used, intravenous (IV) morphine PCA may not be suitable for all patients. Sufentanil sublingual tablet system (SSTS) PCA is a recent technique that has had success as a safe and effective alternative for acute pain management.<h4>Aims</h4>This study aims to compare both the efficacy and safety of SSTS PCA versus IV morphine PCA in postoperative pain control and the quality of recov ...[more]

PMID: 38021565

Similar Datasets

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:BackgroundManaging acute postoperative pain is challenging for anesthesiologists, surgeons, and patients, leading to adverse events despite making significant progress. Patient-controlled intravenous analgesia (PCIA) is a recommended solution, where oxycodone has depicted unique advantages in recent years. However, controversy still exists in clinical practice and this study aimed to compare two drugs in PCIA.MethodsWe performed a literature search in PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, Chinese National Knowledge Infrastructure, Wanfang, and VIP databases up to December 2020 to select specific randomized controlled trials (RCTs) comparing the efficacy of oxycodone with sufentanil in PCIA. The analgesic effect was the primary outcome and the secondary outcome included PCIA consumption, the Ramsay sedation scale, patients' satisfaction and side effects.ResultsFifteen RCTs were included in the meta-analysis. Compared with sufentanil, oxycodone showed lower Numerical Rating Scale scores (mean difference [MD] = -0.71, 95% confidence interval [CI]: -1.01 to -0.41; P < 0.001; I2 = 93%), demonstrated better relief from visceral pain (MD = -1.22, 95% CI: -1.58 to -0.85; P < 0.001; I2 = 90%), promoted a deeper sedative level as confirmed by the Ramsay Score (MD = 0.77, 95% CI: 0.35-1.19; P < 0.001; I2 = 97%), and resulted in fewer side effects (odds ratio [OR] = 0.46, 95% CI: 0.35-0.60; P < 0.001; I2 = 11%). There was no statistical difference in the degree of patients' satisfaction (OR = 1.13, 95% CI: 0.88-1.44; P = 0.33; I2 = 72%) and drug consumption (MD = -5.55, 95% CI: -14.18 to 3.08; P = 0.21; I2 = 93%).ConclusionOxycodone improves postoperative analgesia and causes fewer adverse effects, and could be recommended for PCIA, especially after abdominal surgeries.RegistrationPROSPERO; https://www.crd.york.ac.uk/PROSPERO/; CRD42021229973.

Dataset Information

Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery.

Context

Aims

Settings and design

Methods and material

Results

Conclusions

Publications

Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery.

Similar Datasets

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