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Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Adequate pain control is essential; however, acute pain is often undertreated in prehospital care. This study aimed to evaluate three analgesic regimens for treating acute pain in an ambulance setting. PreMeFen is a randomised, open-label, non-inferiority, three-arm, phase 3 trial conducted in the working areas of the ground ambulance service of the Innlandet Hospital Trust, Norway. Patients aged 18–69 years and 70 years and older with traumatic or medical acute pain scoring 4 or higher on the Numeric Rating Scale (NRS) were randomly assigned (1:1:1) to receive in titration doses 3 mL inhalational methoxyflurane, 50 μg or 100 μg intranasal fentanyl, or 0·05 mg/kg or 0·1 mg/kg intravenous morphine, respectively, depending on the age group. The primary endpoint was change in pain NRS score from baseline to 10 min after treatment start and was analysed per protocol. The non-inferiority margin was 1·3. This trial is registered with ClinicalTrials.gov (NCT05137184) and is completed. Between Nov 12, 2021, and April 22, 2023, 632 patients were assessed for eligibility, and 338 were randomly assigned to methoxyflurane (n=112), fentanyl (n=115), or morphine (n=111). 281 patients were included in the per-protocol population. 145 (52%) of 281 patients were female and 136 (48%) were male. Median age was 61 years (IQR 47–75). The baseline NRS score was 7·6 (SD 1·8). Mean NRS score changes after 10 min were –3·31 (SD 2·67) for methoxyflurane, –1·98 (2·28) for fentanyl, and –2·74 (2·12) for morphine. Comparing changes in mean NRS score while adjusting for baseline showed that methoxyflurane was non-inferior to fentanyl (–1·33 [95% CI –2·01 to –0·64]) and morphine (–0·36 [–1·03 to 0·31]). Intranasal fentanyl was not non-inferior to morphine at 10 min (0·91 [0·27 to 1·55]). Adverse events occurred in 26 (24%) of 109 patients in the morphine group, 27 (24%) of 112 in the fentanyl group, and 24 (22%) of 111 in the methoxyflurane group. Two serious adverse events, respiratory depression (grade 2) and loss of consciousness (grade 3), occurred in the same patient in the methoxyflurane group. There were no treatment-related deaths. Inhalational methoxyflurane is non-inferior to intranasal fentanyl and intravenous morphine for acute pain management in the prehospital environment, assessed 10 min after administration. Inhalational methoxyflurane serves as a valuable non-intravenous alternative in the early phase of treatment and might bridge the gap to longer-acting analgesics. Norwegian Air Ambulance Foundation and Innlandet Hospital Trust.

Shortening analgesic onset has been researched and it has been documented that prewarming epidural medications to body temperature (37°C) prior to administration increases medication efficacy. Our double-blind randomized controlled trial was designed to investigate if a lower degree of prewarming in providers’ pockets could achieve similar results without the need of a bedside incubator. A total of 136 parturients were randomized into either the pocket-warmed group or the room temperature group to receive 10 mL of 0.125% bupivacaine with 2 μg/mL fentanyl epidural bolus at either the 27.8 ±1.7°C or 22.1 ±1.0°C temperatures, respectively. Primary outcome, time to analgesic onset (verbal rating scale pain score ≤ 3) was recorded in 0-, 5-, 10-, 15-, 20-, 30-, and 60-minutes intervals. It was observed that the pocket-warming group (n = 64) and room temperature group (n = 72) had no significant difference of analgesic onset time (median 8 vs. 6.2 minutes; p = 0.322). The incidence of adverse events such as hypotension, fever (≥ 38°C), nausea, vomiting, and number of top-off epidural boluses, as well as patient satisfaction rates and mode of delivery, were not significantly different between the groups as well. Further research is warranted to confirm these findings and explore the impact of different temperatures on analgesic onset time as well as the logistical issues associated with their clinical implementations.

A single-blind, randomized controlled trial comparing oxycodone and fentanyl for patient-controlled intravenous analgesia (PCIA) after laparoscopic hysteromyomectomy found comparable pain relief between the two groups. The study included 60 participants, with NRS scores for pain at rest and when moving showing no significant differences between oxycodone and fentanyl groups at various time points postoperatively. Self-rating depression scale scores were also similar between the groups at 48 h. However, patients’ satisfaction with PCIA was higher in the oxycodone group, with 73.3% reporting being very satisfied compared to 36.7% in the fentanyl group. Additionally, the oxycodone group had fewer incidences of headaches within 48 h postoperatively compared to the fentanyl group. These findings suggest that oxycodone may offer comparable pain relief, higher patient satisfaction, and fewer headaches for patients undergoing laparoscopic hysteromyomectomy compared to fentanyl, making it a suitable option for postoperative pain management in this population. Clinical trial registration number The study was registered with CHICTR.org, ChiCTR2100051924.

Fentanyl is often administered during rapid sequence induction of anesthesia (RSI) in the emergency department (ED) to ameliorate the hypertensive response that may occur. Due to its more rapid onset, the use of alfentanil may be more consistent with both the onset time of the sedative and the commencement of laryngoscopy. As such, we compared the effect of alfentanil and fentanyl on post-induction hemodynamic changes when administered as part of a standardized induction regimen including ketamine and rocuronium in ED RSI. This was a double-blind pilot randomized controlled trial of adult patients requiring RSI in the ED of three urban Australian hospitals. Patients were randomized to receive either alfentanil or fentanyl in addition to ketamine and rocuronium for RSI. Non-invasive blood pressure and heart rate were measured immediately before and at two, four, and six minutes after induction. The primary outcome was the occurrence of at least one post-induction systolic blood pressure outside the pre-specified range of 100-160mmHg (with adjustment for patients with baseline hypertension). Secondary outcomes included hypertension, hypotension, hypoxia, first-pass intubation success, 30-day mortality, and the pattern of hemodynamic changes. A total of 61 patients were included in the final analysis (31 in the alfentanil group and 30 in the fentanyl group). The primary outcome was met in 58% of the alfentanil group and 50% of the fentanyl group (difference 8%, 95% confidence interval: -17% to 33%). The 30-day mortality rate, first-pass success rate, and incidences of hypertension, hypotension, and hypoxia were similar between the groups. There were no significant differences in systolic blood pressure or heart rate between the groups at any of the measured time-points. Alfentanil and fentanyl produced comparable post-induction hemodynamic changes when used as adjuncts to ketamine in ED RSI. Future studies could consider comparing different dosages of these opioids.

The ideal analgesic is not known for patients with acute pancreatitis (AP). Concerns have been raised about serious adverse effects of opioid analgesics increasing the severity of AP. We hypothesized that nonsteroidal anti-inflammatory drugs might be better analgesics because of their anti-inflammatory effect. Our objective was to compare pentazocine, an opioid, and diclofenac, a nonsteroidal anti-inflammatory drug, for adequate analgesia in patients with AP. In a double-blind randomized controlled trial, patients with AP were randomized to either intravenous diclofenac 75 mg or pentazocine 30 mg. Fentanyl was given as a rescue analgesic through a patient-controlled analgesia pump. Primary outcome was pain relief measured objectively by the dose of fentanyl required as the rescue analgesic, pain-free period, and numbers of effective and ineffective demands of fentanyl. Secondary outcome was adverse events. Fifty patients were randomized, 24 to the pentazocine group and 26 to the diclofenac group. Baseline characteristics were comparable between the groups. Pentazocine was found to be better than diclofenac in terms of significantly lower dose of the rescue analgesic (fentanyl) required (126 μg (interquartile range (IQR) 65-218 μg) vs 225.5 μg (IQR 133-427 μg); P = 0.028) and longer pain-free period (31.1 ± 8.2 vs 27.9 ± 6.6 hours, P = 0.047). The number of effective and ineffective demands was lower in the pentazocine group compared with the diclofenac group (11.5 (IQR 8-15) vs 16 (IQR 13-20), P = 0.098) although not statistically significant. Adverse events were similar between the groups. Pentazocine, a kappa-opioid receptor agonist, was significantly better than diclofenac for pain relief in AP (Trial registration number: CTRI/2016/09/007326).

Hip fractures frequently cause severe pain and functional decline in adults presenting to emergency departments (EDs). Although intravenous (IV) opioids are widely used for pain control, their use may be limited by adverse effects, especially in patients with comorbidities or cognitive impairment. Ultrasound-guided femoral nerve block (FNB) offers a regional analgesic technique that may provide effective pain relief while reducing opioid-related complications. However, comparative randomized trials in the ED setting remain limited. In this single-center, randomized, double-blind clinical trial, adult patients with radiologically confirmed hip fractures were assigned to receive either ultrasound-guided FNB (20 mL 0.5 % bupivacaine) or IV fentanyl (1 μg/kg). To preserve blinding, patients in each group received a placebo injection mimicking the alternative treatment. Pain severity was measured at baseline and 20 min post-intervention using the Numeric Pain Rating Scale or the Pain Assessment in Advanced Dementia Scale (PAINAD), based on cognitive status. The primary outcome was change in pain score at 20 min. Secondary outcomes included rescue analgesia requirement within four hours and adverse events. A total of 104 patients were enrolled and randomized. The FNB group experienced greater median pain reduction compared to the fentanyl group (4 [IQR 3–5] vs. 2 [IQR 2–3]; median difference: 2, 95 % CI: 1–2). Rescue analgesia was required in 21.1 % of FNB patients versus 61.5 % in the fentanyl group. Adverse events were observed only in the fentanyl group, including nausea (23 %), dizziness (15 %), headache (9.6 %), and hypotension (5.7 %). No FNB-related complications were reported. Subgroup analysis showed consistent efficacy among cognitively impaired patients. FNB resulted in superior analgesia, fewer side effects, and lower need for rescue opioids compared to IV fentanyl. Additionally, FNB has shown an effective and safe pain control in patients with cognitive impairment compared to patients without cognitive impairment. Trial registration:ClinicalTrials.gov Identifier: NCT06862154. •Femoral nerve block (FNB) reduced pain more than IV fentanyl in ED patients with hip fractures.•Rescue opioid use was significantly lower in the FNB group (21.1 %) than in the fentanyl group (61.5 %).•Adverse events occurred only in the fentanyl group, including nausea (23 %) and hypotension (5.7 %).•FNB was safe, with no complications observed in any of the patients who received the block.

Study Objectives: Postoperative respiratory adverse events (PRAE) occurred more frequently in children having adenotonsillectomy than the general surgical population, and can require escalation of care. This study aims to assess the usefulness of postinduction fentanyl-test to predict PRAE in children with obstructive sleep apnea after adenotonsillectomy. Methods: Two hundred and forty patients with obstructive sleep apnea undergoing adenotonsillectomy were included in this study. The oxygen saturation during sleep was monitored the night before adenotonsillectomy. Fentanyl-test was conducted under spontaneous breath after anesthesia induction with sevoflurane. Fentanyl-induced reduction in respiratory rate (FRR) was defined as the percentage of reduction in respiratory rate after 1 mcg/kg fentanyl administration. PRAE in the postanesthesia care unit included both respiratory complications and medical interventions. Receiver operating characteristic analysis was used to assess the usefulness of fentanyl-test in predicting PRAE. Results: Of the 240 children undergoing elective adenotonsillectomy, 38 children (16%) experienced PRAE in postanesthesia care unit. The areas under receiver operating characteristic curve for FRR and nadir pulse oxygen saturation were 0.756 and 0.692, respectively. FRR greater than 53% best predicted PRAE in postanesthesia care unit, with a sensitivity of 68% and a specificity of 72%. Patients with FRR > 53% exhibited a significantly longer duration of desaturation requiring supplementary oxygen than those with FRR ≦ 53% ( P < .001). Conclusions: We suggest that postinduction fentanyl-test is a feasible evaluation for children undergoing adenotonsillectomy to predict early PRAE, especially for those who have not undergone polysomnography. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Effects of Individualized Opioid Analgesia Versus Conventional Opioid Analgesia After Adenotonsillectomy in Children; URL: https://clinicaltrials.gov/study/NCT04527393 ; Identifier: NCT04527393. Citation: Liu H-E, He L. The performance of a post-induction fentanyl-test in predicting postoperative respiratory adverse events in children after adenotonsillectomy. J Clin Sleep Med . 2024;20(11):1749–1754.

Exercise intolerance and exertional dyspnoea are hallmarks of fibrosing interstitial lung disease (FILD) and are associated with worse prognosis and quality of life. Activation of pulmonary vagal afferents influences the ventilatory pattern and contributes to the sensation of dyspnoea. We tested the hypothesis that nebulized fentanyl, which might attenuate aberrant pulmonary afferent activity in FILD, reduces ventilation and dyspnoea while extending exercise endurance time (EET). In this randomized, single‐blind, placebo‐controlled study, eight FILD patients (two males, 71 ± 6 years of age) performed incremental cardiopulmonary cycle exercise tests following nebulization of either fentanyl citrate (100 µg) or 0.9% saline. Previous work indicated that this dose was unlikely to produce central effects. Comparisons between treatment conditions at rest were undertaken using Student's paired t‐test, and exercise data were evaluated with two‐way ANOVA with repeated measures. Dyspnoea was assessed using the Borg dyspnoea scale. Resting respiratory variables were not different following treatment with fentanyl and saline; however, resting heart rate was lower following fentanyl (P = 0.002) and remained lower throughout exercise compared with placebo (P = 0.008). Fentanyl did not increase EET (placebo 334 ± 117 s vs. fentanyl 348 ± 126 s, P = 0.250) although overall minute ventilation was reduced slightly (mean difference: −0.97 L/min, P = 0.022). There were no differences in ratings of dyspnoea intensity or unpleasantness between the conditions either at rest or at end‐exercise. Nebulized fentanyl did not improve EET or exercise dyspnoea but did decrease minute ventilation during exercise, although the extent of this reduction appears clinically insignificant. These findings suggest that nebulized fentanyl is unlikely to offer significant benefits for enhancing exercise capacity in FILD. What is the central question of this study? Fibrotic interstitial lung disease is associated with dyspnoea and exercise intolerance. The role of bronchopulmonary vagal afferents is not completely understood. We asked whether nebulized fentanyl could attenuate sensory feedback and improve exercise capacity. What is the main finding and its importance? Nebulized fentanyl reduced exercise ventilation compared with placebo; however, the small magnitude of this reduction means that it is unlikely to be clinically significant. Exercise endurance time, peak ventilation and dyspnoea scores were unchanged. Nebulized fentanyl is therefore unlikely to offer significant benefits for enhancing exercise capacity in fibrotic interstitial lung disease.

Introduction Using pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA. Methods The NONA-LISA trial (ClinicalTrials.gov, NCT05609877) is a multicentre, blinded, randomised controlled trial aiming at including 324 infants born before 30 gestational weeks, meeting the criteria for surfactant treatment by LISA. Infants will be randomised to LISA after administration of fentanyl 0.5–1 mcg/kg intravenously (fentanyl group) or isotonic saline solution intravenously (saline group). All infants will receive standardised non-pharmacological comfort care before and during the LISA procedure. Additional analgesics will be provided at the clinician’s discretion. The primary outcome is the need for invasive ventilation, meaning mechanical or manual ventilation via an endotracheal tube, for at least 30 min (cumulated) within 24 h of the procedure. Secondary outcomes include the modified COMFORTneo score during the procedure, bronchopulmonary dysplasia at 36 weeks, and mortality at 36 weeks. Discussion The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice. Impact Pre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA). This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort. The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.