Efficacy of intravenous nalbuphine for managing post-anaesthesia shivering: A systematic review and meta-analysis of randomised controlled trials with trial sequential analysis
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SUBMITTER: Nair A
PROVIDER: S-EPMC10691608 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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Project description:PurposePostoperative shivering (POS) is a common and vital complication after anesthesia, which may result in serious consequences and uncomfortable experiences. Acetaminophen has been used to treat fever and mild to moderate pain. However, there is not enough evidence to prove its advantage for POS. This meta-analysis aimed to explore the prophylactic use of acetaminophen as a valid agent for POS.MethodsTwo researchers independently searched PubMed, the Cochrane Library, and Embase for controlled clinical trials. The meta-analysis of randomized controlled trials (RCTs) was performed by Review Manager.ResultsNine trials with 856 patients were included in our meta-analysis. Acetaminophen significantly reduced POS compared with placebo (pooled risk ratio [RR]: 0.43, 95% confidence interval [CI]: 0.35-0.52). What is more, not only 15 mg/kg but also 1000 mg intravenous acetaminophen could reduce the incidence of shivering compared with placebo.ConclusionOur present meta-analysis demonstrates that the intravenous prophylactic infusion of acetaminophen may prevent POS, and the results may provide new evidence to expand the clinical value of acetaminophen in addition to its routine usage.
| S-EPMC11245272 | biostudies-literature
Project description:ObjectivePerioperative shivering (POS) is a common complication in patients undergoing spinal anaesthesia. The present study investigated the efficacy of 5-HT3 receptor antagonists in preventing POS following spinal anaesthesia.DesignSystematic review and meta-analysis.Data sourcesPubmed, Embase, the Web of Science and Cochrane Library were searched from database establishment on 31 July 2019.Eligibility criteriaRandomised controlled trials that reported the effects of 5-HT3 receptor antagonists in the prevention of POS in patients after spinal anaesthesia.Data extraction and synthesisTwo reviewers independently extracted data. The primary outcome of the present study was the incidence of POS. The risk of bias for the included studies was assessed according to the Cochrane Handbook. The quality of primary outcome was evaluated by Grading of Recommendations Assessment, Development and Evaluation. Trial sequential analysis for the primary outcome was performed to reduce the type 1 error caused by repeated meta-analysis and the required information size was calculated.ResultsA total of 13 randomised controlled trials consisting of 1139 patients were included. The overall incidence of POS was significantly lower in the 5-HT3 receptor antagonists group (risk ratio 0.31; 95% CI 0.26 to 0.38; p<0.01; I2=0%). Subgroup analysis for different types of 5-HT3 receptor antagonists and timing of administration produced similar results. Also, patients had a lower incidence of postoperative nausea and vomiting after administrating 5-HT3 receptor antagonists. No statistically significant differences in drug-related adverse effects were observed. Grading of Recommendations Assessment, Development and Evaluation revealed a high level of evidence. The cumulative z-curve crossed the trial sequential monitoring boundary.ConclusionsThe present study revealed that prophylactic 5-HT3 receptor antagonists were an effective measure for reducing the incidence of POS in patients after spinal anaesthesia. However, further studies investigating the different types of surgeries are required.Prospero registration numberCRD42019148191.
| S-EPMC7537433 | biostudies-literature
Project description:BackgroundPatients often experience shivering after spinal anesthesia. In recent years, more and more studies have compared the efficacy and side effects of intravenous butorphanol and tramadol in the treatment of shivering after spinal anesthesia. Therefore, we conducted a MATE analysis and systematic review to compare the efficacy and side effects of butorphanol vs. tramadol in the treatment of shivering after spinal anesthesia.MethodsPubMed, Cochrane Library, and Embase databases were searched for randomized controlled trials (RCTs) from inception to 30 December 2022, comparing the effects of butorphanol vs. tramadol for the control of shivering after spinal anesthesia. Data assessment and collection were analyzed using the Review Manager 5.4 software.ResultsFive randomized controlled trials involving 302 adult patients were included in this meta-analysis. The results showed that butorphanol has a shorter time to cease shivering (standardized mean difference (SMD) = -0.53; 95% confidence interval (CI) [-0.89, -0.17], P = 0.004, I2 = 0%), a higher rate of cessation of shivering within 1 min after administering the study drugs (relative risk (RR), 1.69; 95% CI [1.15,2.48], P = 0.008, I2 = 0%), and higher incidences of sedation (RR, 2.98; 95% CI [2.11, 4.21], P <0.00001, I2 = 0%), compared with tramadol.ConclusionIn the treatment of shivering after spinal anesthesia, butorphanol has a shorter onset time and a higher rate of cessation of shivering within 1 min after the study drugs were administered than tramadol. Therefore, butorphanol is superior to tramadol in the treatment of shivering after spinal anesthesia.
| S-EPMC10729005 | biostudies-literature
Project description:The aim of this systematic review and meta-analysis is to evaluate the pros and cons of adjuvant low dose intrathecal meperidine for spinal anaesthesia. We searched electronic databases for randomized controlled trials using trial sequential analysis (TSA) to evaluate the incidence of reduced rescue analgesics, shivering, pruritus, nausea and vomiting when applying adjuvant intrathecal meperidine. Twenty-eight trials with 2216 patients were included. Adjuvant intrathecal meperidine, 0.05-0.5 mg kg-1, significantly reduced incidence of shivering (relative risk, RR, 0.31, 95% confidence interval, CI, 0.24 to 0.40; TSA-adjusted RR, 0.32, 95% CI, 0.25 to 0.41). Intrathecal meperidine also effectively reduced need for intraoperative rescue analgesics (RR, 0.27, 95% CI, 0.12 to 0.64; TSA-adjusted RR, 0.27, 95% CI, 0.08 to 0.91) and the incidence of pruritus was unaffected (RR, 2.31, 95% CI, 0.94 to 5.70; TSA-adjusted RR, 1.42, 95% CI, 0.87 to 2.34). However, nausea and vomiting increased (RR, 1.84, 95% CI, 1.29 to 2.64; TSA-adjusted RR, 1.72, 95% CI, 1.33 to 2.23; RR, 2.23, 95% CI, 1.23 to 4.02; TSA-adjusted RR,1.96, 95% CI, 1.20 to 3.21). Under TSA, these results provided a sufficient level of evidence. In conclusion, adjuvant low dose intrathecal meperidine effectively attenuates spinal anaesthesia-associated shivering and reduces rescue analgesics with residual concerns for the nausea and vomiting.
| S-EPMC5681692 | biostudies-literature
Project description:To further identify the real efficacy and safety of dexmedetomidine as an adjuvant to local wound infiltration anaesthesia, we conducted this meta-analysis. The systematic search strategy was performed using PubMed, Embase, Cochrane Library, and Chinese databases. As a result, a total of 23 RCTs (1445 patients) were included. Patients receiving dexmedetomidine combined with local anaesthetics had a lower rescue analgesia rate [risk ratio (RR): 0.48; 95% confidence interval (CI): 0.36-0.65] and lower rescue analgesic consumption [weighted mean difference (WMD): -10.80 mg; 95%CI: -13.28 to -8.31 mg] than patients receiving local anaesthetics alone. The dexmedetomidine-related adverse reactions included bradycardia (RR: 1.33; 95%CI: 0.32-5.56) and hypotension (RR: 3.00; 95%CI: 0.49-18.42). In addition, the time to first analgesic request (WMD: 296.16 minutes; 95%CI: 165.69 minutes ~ 426.63 minutes), incidence of postoperative nausea and vomiting (PONV) and pain scores at 4 hours postoperatively were also significantly lower in patients receiving dexmedetomidine combined with local anaesthetics. This meta-analysis demonstrated that the use of dexmedetomidine as an adjuvant to wound infiltration is effective for reducing the rescue analgesia rate, rescue analgesic consumption and PONV. In addition, limited evidence shows that dexmedetomidine can prolong postoperative analgesia for approximately 5 hours. Further investigations on dexmedetomidine-related adverse reactions and the dose-response effect of dexmedetomidine in wound infiltration are warranted.
| S-EPMC7949019 | biostudies-literature
Project description:BACKGROUND:Several studies have investigated the effects of dexamethasone on post-operative cognitive dysfunction (POCD) or post-operative delirium (POD); however, their conclusions have been inconsistent. Thus, we conducted a meta-analysis to determine the effects of dexamethasone on POCD and POD in adults following general anaesthesia. METHODS:The Cochrane Central Register of Controlled Trials (2018, Issue 11 of 12) in the Cochrane Library (searched 17 November 2018), MEDLINE OvidSP (1946 to 16 November 2018) and Embase OvidSP (1974 to 16 November 2018) were searched for randomised controlled trials that evaluated the incidence of POCD and POD following dexamethasone administration in adults (age ≥ 18 years) under general anaesthesia. We used the Grading of Recommendations, Assessment, Development and Evaluations framework to assess the quality of the evidence. RESULTS:Five studies were included (three studies with 855 participants in the dexamethasone group and 538 participants in the placebo group for the incidence of POCD, and two studies with 410 participants in the dexamethasone group and 420 participants in the placebo group for the incidence of POD). There was no significant difference between the dexamethasone group and the placebo group in terms of the incidence of POCD 30 days after surgery (RR [relative risk] 1.00; 95% CI [confidence interval: 0.51, 1.96], P = 1.00, I2 = 77%) or the incidence of POD (RR 0.96; 95% CI [0.68, 1.35], P = 0.80, I2 = 0%). However, both analyses had some limitations because of limited evidence and clinical heterogeneity, and we considered the quality of the evidence for the post-operative incidence of POCD and POD to be very low. CONCLUSIONS:This meta-analysis revealed that prophylactic dexamethasone did not reduce the incidence of POCD and POD. Trials of alternative preventive strategies for POCD and POD, as well as a better understanding of the pathophysiology of those complex syndromes, are still needed to make progress in this field. TRIAL REGISTRATIONR:This study is registered with PROSPERO, 23 October 2018, number CRD42018114552. Available from https://www.crd.york.ac.uk/PROSPERO/#recordDetails .
| S-EPMC6599229 | biostudies-literature
Project description:ObjectivesThe objective of this pharmacometric (PMX) study was to (i) characterize population pharmacokinetics (PPK) and exposure-pain response associations following intranasal (0.1 mg/kg) or intravenous (IV, 0.05 mg/kg) administration of nalbuphine, with the goal to (ii) evaluate strategies for optimized dosing and timing of painful interventions in infants 1-3 months old.MethodsPPK analysis of nalbuphine serum concentrations, prospectively collected 15, 30, and between 120 and 180 min post-dose, utilizing the software package Monolix. The final PPK model was applied to derive individual time-matched concentration predictions for each pain assessment (Neonatal Infant Pain Score, NIPS) after establishment of venous access and urinary catheterization or lumbar puncture. Drug exposure-pain response simulations were performed to evaluate potential benefits of higher doses with respect to a previously proposed target concentration of 12 mcg/L (efficacy threshold).ResultsThirty-eight of 52 study subjects receiving nalbuphine had at least one concentration measurement and were included in the pharmacometric analysis. A two-compartment model with allometric scaling was applied to describe population PK data, with intranasal bioavailability estimated to be 41% (95%CI: 26-56%). Model-based simulations showed that the proposed efficacy threshold (12 mcg/L) is expected to be exceeded with an IV dose of 0.05 mg/kg for 6 min, with 0.1 mg/kg for 30 min and with 0.2 mg/kg for 80 min. This efficacy threshold is not achieved with intranasal doses of 0.1 and 0.2 mg/kg, whereas an intranasal dose of 0.4 mg/kg is expected to exceed such threshold for 30 to 100 min.ConclusionThis PMX study confirmed that bioavailability of intranasal nalbuphine is close to 50%. Exposure-pain response simulations indicated that an intranasal dose of 0.4 mg/kg is required to provide a comparable pain control as achieved with an IV dose of 0.1-0.2 mg/kg. The optimal time window for painful procedures appears to be within the first 30 min after IV administration of 0.1 mg/kg nalbuphine, whereas such procedures should be scheduled 30 min after an intranasal dose of 0.4 mg/kg nalbuphine. Additional clinical studies are warranted to confirm these PMX based recommendations and to further optimize pain management in this vulnerable infant population.
| S-EPMC8926166 | biostudies-literature
Project description:BackgroundImproving outcomes after surgery is a major public health research priority for patients, clinicians and the NHS. The greatest burden of perioperative complications, mortality and healthcare costs lies amongst the population of patients aged over 50 years who undergo major non-cardiac surgery. The Volatile vs Total Intravenous Anaesthesia for major non-cardiac surgery (VITAL) trial specifically examines the effect of anaesthetic technique on key patient outcomes: quality of recovery after surgery (quality of recovery after anaesthesia, patient satisfaction and major post-operative complications), survival and patient safety.MethodsA multi-centre pragmatic efficient randomised trial with health economic evaluation comparing total intravenous anaesthesia with volatile-based anaesthesia in adults (aged 50 and over) undergoing elective major non-cardiac surgery under general anaesthesia.DiscussionGiven the very large number of patients exposed to general anaesthesia every year, even small differences in outcome between the two techniques could result in substantial excess harm. Results from the VITAL trial will ensure patients can benefit from the very safest anaesthesia care, promoting an early return home, reducing healthcare costs and maximising the health benefits of surgical treatments.Trial registrationISRCTN62903453. September 09, 2021.
| S-EPMC11210167 | biostudies-literature
Project description:ObjectivesThis study aimed to determine if low dose intravenous ketamine is effective in reducing opioid use and pain after non-elective caesarean delivery.DesignProspective, randomised, double-blind.SettingTertiary hospital, Bisheshwar Prasad Koirala Institute of Health Sciences, Dharan, Nepal PARTICIPANTS: 80 patients undergoing non-elective caesarean section with spinal anaesthesia.InterventionsPatients were allocated in 1:1 ratio to receive either intravenous ketamine 0.25 mg/kg or normal saline before the skin incision.Primary and secondary outcome measuresThe primary outcome was the total amount of morphine equivalents needed up to postoperative 24 hours. Secondary outcome measures were postoperative pain scores, time to the first perception of pain, maternal adverse effects (nausea, vomiting, hypotension, shivering, diplopia, nystagmus, hallucination) and neonatal Apgar score at 1 and 5 min, neonatal respiratory depression and neonatal intensive-care referral.ResultsThe median (range) cumulative morphine consumption during the first 24 hours of surgery was 0 (0-4.67) mg in ketamine group and 1 (0-6) mg in saline group (p=0.003). The median (range) time to the first perception of pain was 6 (1-12) hours and 2 (0.5-6) hours in ketamine and saline group, respectively (p<0.001). A significant reduction in postoperative pain scores was observed only at 2 hours and 6 hours in the ketamine group compared with placebo group (p<0.05). Maternal adverse effects and neonatal outcomes were comparable between the two groups.ConclusionsIntravenous administration of low dose ketamine before surgical incision significantly reduced the opioid requirement in the first 24 hours in patients undergoing non-elective caesarean delivery.Trial registration numberNCT03450499.
| S-EPMC8246353 | biostudies-literature
Project description:BackgroundThe recent AFFIRM-AHF trial assessing the effect of intravenous (IV) iron on outcomes in patients hospitalised with worsening heart failure who had iron deficiency (ID) narrowly missed its primary efficacy endpoint of recurrent hospitalisations for heart failure (HHF) or cardiovascular (CV) death. We conducted a meta-analysis to determine whether these results were consistent with previous trials.MethodsWe searched for randomised trials of patients with heart failure investigating the effect of IV iron vs placebo/control groups that reported HHF and CV mortality from 1st January 2000 to 5th December 2020. Seven trials were identified and included in this analysis. A fixed effect model was applied to assess the effects of IV iron on the composite of first HHF or CV mortality and individual components of these.ResultsAltogether, 2,166 patients were included (n = 1168 assigned to IV iron; n = 998 assigned to control). IV iron reduced the composite of HHF or CV mortality substantially [OR 0.73; (95% confidence interval 0.59-0.90); p = 0.003]. Outcomes were consistent for the pooled trials prior to AFFIRM-AHF. Whereas first HHF were reduced substantially [OR 0.67; (0.54-0.85); p = 0.0007], the effect on CV mortality was uncertain but appeared smaller [OR 0.89; (0.66-1.21); p = 0.47].ConclusionAdministration of IV iron to patients with heart failure and ID reduces the risk of the composite outcome of first heart failure hospitalisation or cardiovascular mortality, but this outcome may be driven predominantly by an effect on HHF. At least three more substantial trials of intravenous iron are underway.
| S-EPMC8318946 | biostudies-literature