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In a trial of galcanezumab, an antibody to calcitonin gene–related peptide, for the treatment of cluster headache, a subcutaneous dose reduced the mean weekly frequency of cluster attacks from 17.8 to 9.1, as compared with 17.3 to 12.1 in the placebo group. Injection-site reactions occurred in 8% of the patients receiving galcanezumab.

BackgroundDexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. During bariatric surgery, its use may reduce postoperative opioid requirements, reduce their side effects, and improve quality of recovery.The aim of this prospective randomized controlled trial was to compare the effect of dexmedetomidine bolus and infusion versus morphine bolus given prior to the end of laparoscopic bariatric surgery.MethodsSixty morbidly obese patients (BMI > 40 kg m−2) aged 18 to 60 years, undergoing laparoscopic sleeve gastrectomy, received morphine sulfate (bolus 0.08 mg kg−1 followed by a saline infusion) (group M, n = 30) or dexmedetomidine (loading dose of 1 μg kg−1 followed by 0.5 μg kg−1 h−1) (group D, n = 30) 30 min before the end of surgery.Data collected included morphine consumption in the post-anesthesia care unit (PACU) (primary outcome) and at 24 h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery.ResultsThere was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01). Group D patients had more cardiovascular stability.ConclusionsDexmedetomidine given prior to end of laparoscopic sleeve gastrectomy provides the same level of postoperative analgesia as morphine with better hemodynamic profile.

Delirium is a common and serious postoperative complication. Subanaesthetic ketamine is often administered intraoperatively for postoperative analgesia, and some evidence suggests that ketamine prevents delirium. The primary purpose of this trial was to assess the effectiveness of ketamine for prevention of postoperative delirium in older adults. The Prevention of Delirium and Complications Associated with Surgical Treatments [PODCAST] study is a multicentre, international randomised trial that enrolled adults older than 60 years undergoing major cardiac and non-cardiac surgery under general anaesthesia. Using a computer-generated randomisation sequence we randomly assigned patients to one of three groups in blocks of 15 to receive placebo (normal saline), low-dose ketamine (0·5 mg/kg), or high dose ketamine (1·0 mg/kg) after induction of anaesthesia, before surgical incision. Participants, clinicians, and investigators were blinded to group assignment. Delirium was assessed twice daily in the first 3 postoperative days using the Confusion Assessment Method. We did analyses by intention-to-treat and assessed adverse events. This trial is registered with clinicaltrials.gov, number NCT01690988. Between Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were randomly assigned, with 222 in the placebo group, 227 in the 0·5 mg/kg ketamine group, and 223 in the 1·0 mg/kg ketamine group. There was no difference in delirium incidence between patients in the combined ketamine groups and the placebo group (19·45% vs 19·82%, respectively; absolute difference 0·36%, 95% CI −6·07 to 7·38, p=0·92). There were more postoperative hallucinations (p=0·01) and nightmares (p=0·03) with increasing ketamine doses compared with placebo. Adverse events (cardiovascular, renal, infectious, gastrointestinal, and bleeding), whether viewed individually (p value for each >0·40) or collectively (36·9% in placebo, 39·6% in 0·5 mg/kg ketamine, and 40·8% in 1·0 mg/kg ketamine groups, p=0·69), did not differ significantly across groups. A single subanaesthetic dose of ketamine did not decrease delirium in older adults after major surgery, and might cause harm by inducing negative experiences. National Institutes of Health and Cancer Center Support.

VVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2 A. In this Phase 3 study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after laparoscopic colectomy. Randomized, parallel group, double-blind, Phase 3 clinical trial (Trial no. NCT05764525). 5 tertiary referral centers in South Korea. 284 patients undergoing laparoscopic colectomy. A continuous 10-h intravenous infusion of VVZ-149 (n = 141) or placebo (n = 143) administered after emergence from anesthesia. Pain intensity was assessed using a numeric rating scale (NRS) from the start of infusion for 48 h. The primary efficacy measure was the Sum of Pain Intensity Difference (SPID) for the first 12 h after the start of drug infusion. Other efficacy measures included SPID at other time points, opioid consumption via on-demand patient-controlled analgesia (PCA) and rescue medication, and proportion of patients who did not require rescue opioids for 48 h post-dose. Pain relief as measured by SPID was significantly improved by 35 % in the VVZ-149 group compared to the placebo group at 6 h (p = 0.0193) and 12 h (p = 0.0047) after the start of infusion. Significantly lower pain intensity scores were observed between 4–10 h in the VVZ-149 group compared to the placebo group (p = 0.0007), reaching mild pain (mean NRS <4) at 8 h. VVZ-149 alleviated pain during the first 12 h post-dose with 30.8 % less opioid consumption and 60.2 % fewer PCA requests when compared with placebo. A higher proportion of patients receiving VVZ-149 were rescue opioid-free during 2–6 h (p = 0.0026) and 6–12 h (p = 0.0024) compared with the placebo group. VVZ-149 administration in post-colectomy patients was generally safe and well tolerated. When compared to placebo, VVZ-149 infusion demonstrated a significant reduction of pain within the first 12 h after surgery with a substantial decrease in opioid use. VVZ-149 rapidly lowers the pain intensity starting at as early as 4 h post-dose, allowing subjects to experience mild pain levels from 8 h through 48 h. Therefore, the analgesic effect of VVZ-149 was shown to effectively relieve pain and reduce opioid use for treating moderate to severe pain in the early postoperative care setting. Registration number: Trial Number NCT05764525 •VVZ-149 is a non-opioid, non-NSAID analgesic drug candidate.•VVZ-149 inhibits both the type 2 glycine transporter and type 2A serotonin receptor.•VVZ-149 significantly lower pain levels for first 12 h of study drug infusion.•VVZ-149 substantially reduced opioid use and PCA requests after surgery.•VVZ-149 offers safe and rapid pain relief that minimizes postoperative opioid use.

Background Two of the more common methods of pain management after TKA are peripheral nerve blocks and intraarticular/periarticular injections. However, we are not aware of any study directly comparing the commonly used combination of a continuous femoral block given with a single-shot sciatic block with that of a periarticular injection after TKA. Questions/purposes This randomized clinical trial compared a combined femoral and sciatic nerve block with periarticular injection as part of a multimodal pain protocol after total knee arthroplasty with respect to (1) pain; (2) narcotic use; (3) quadriceps function and length of stay; and (4) peripheral nerve complications. Methods One hundred sixty patients completed randomization into two treatment arms: (1) peripheral nerve blocks (PNB; n = 79) with an indwelling femoral nerve catheter and a single shot sciatic block; or (2) periarticular injection (PAI; n = 81) using ropivacaine, epinephrine, ketorolac, and morphine. All patients received standardized general anesthesia and oral medications. The primary outcome was postoperative pain, on a 0 to 10 scale, measured on the afternoon of postoperative day 1 (POD 1). Secondary outcomes were narcotic use, quadriceps function, length of stay, and peripheral nerve complications. Results Mean pain scores on the afternoon of POD 1 were not different between groups (PNB group: 2.9 [SD 2.4]; PAI group: 3.0 [SD 2.2]; 95% confidence interval, −0.8 to 0.6; p = 0.76). Mean pain scores taken at three times points on POD 1 were also similar between groups. Hospital length of stay was shorter for the PAI group (2.44 days [SD 0.65] versus 2.84 days [SD 1.34] for the PNB group; p = 0.02). Narcotic consumption was higher the day of surgery for the PAI group (PAI group: 11.7 mg morphine equivalents [SD 13.1]; PNB group: 4.6 mg [SD 9.1]; p < 0.001), but thereafter, there was no difference. More patients in the PNB group had sequelae of peripheral nerve injury (mainly dysesthesia) at 6-week followup (nine [12%] versus one [1%]; p = 0.009). Conclusions Patients receiving periarticular injections had similar pain scores, shorter lengths of stay, less likelihood of peripheral nerve dysesthesia, but greater narcotic use on the day of surgery compared with patients receiving peripheral nerve blocks. Periarticular injections provide adequate pain relief, are simple to use, and avoid the potential complications associated with nerve blocks. Level of Evidence Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Background To determine whether intermittent intravenous (IV) paracetamol as primary analgesic would significantly reduce morphine consumption in children aged 0–3 years after cardiac surgery with cardiopulmonary bypass. Methods Multi-center, randomized, double-blinded, controlled trial in four level-3 Pediatric Intensive Care Units (PICU) in the Netherlands and Belgium. Inclusion period; March 2016–July 2020. Children aged 0–3 years, undergoing cardiac surgery with cardiopulmonary bypass were eligible. Patients were randomized to continuous morphine or intermittent IV paracetamol as primary analgesic after a loading dose of 100 mcg/kg morphine was administered at the end of surgery. Rescue morphine was given if numeric rating scale (NRS) pain scores exceeded predetermined cutoff values. Primary outcome was median weight-adjusted cumulative morphine dose in mcg/kg in the first 48 h postoperative. For the comparison of the primary outcome between groups, the nonparametric Van Elteren test with stratification by center was used. For comparison of the proportion of patients with one or more NRS pain scores of 4 and higher between the two groups, a non-inferiority analysis was performed using a non-inferiority margin of 20%. Results In total, 828 were screened and finally 208 patients were included; parents of 315 patients did not give consent and 305 were excluded for various reasons. Fourteen of the enrolled 208 children were withdrawn from the study before start of study medication leaving 194 patients for final analysis. One hundred and two patients received intermittent IV paracetamol, 106 received continuous morphine. The median weight-adjusted cumulative morphine consumption in the first 48 h postoperative in the IV paracetamol group was 5 times lower (79%) than that in the morphine group (median, 145.0 (IQR, 115.0–432.5) mcg/kg vs 692.6 (IQR, 532.7–856.1) mcg/kg; P  <  0.001 ). The rescue morphine consumption was similar between the groups (p = 0.38). Non-inferiority of IV paracetamol administration in terms of NRS pain scores was proven; difference in proportion − 3.1% (95% CI − 16.6–10.3%). Conclusions In children aged 0–3 years undergoing cardiac surgery, use of intermittent IV paracetamol reduces the median weight-adjusted cumulative morphine consumption in the first 48 h after surgery by 79% with equal pain relief showing equipoise for IV paracetamol as primary analgesic. Trial Registration Clinicaltrials.gov, Identifier: NCT05853263; EudraCT Number: 2015-001835-20.

In a randomized trial involving patients with sciatica, the antiepileptic drug pregabalin, at a dose of up to 600 mg per day, was no more effective than placebo in reducing pain or disability over the course of 8 weeks and resulted in a higher incidence of adverse events. Sciatica is characterized by radiating posterior or posterolateral leg pain, which is sometimes accompanied by back pain, sensory loss, weakness, or reflex abnormalities. 1 – 3 Few clinical guidelines for the treatment of sciatica exist, and evidence regarding effective medical treatments is limited. 2 , 3 Treatment with pregabalin (Lyrica, Pfizer) has been shown to be effective in reducing some types of neuropathic pain, including postherpetic neuralgia and diabetic peripheral neuropathy, 4 , 5 as well as allodynia and hyperalgesia from several conditions, 6 – 8 and some guidelines recommend pregabalin for the treatment of pain with neuropathic features. 5 Pregabalin therefore represents a potential treatment for sciatica. Its . . .

Background The three-step analgesic ladder, recommended by the World Health Organization (WHO), serves as a guideline for managing cancer pain, progressing from non-opioids to weak opioids and strong opioids based on pain intensity. Despite its widespread use, challenges in standardizing its application persist, impacting medication safety and efficacy. This study aimed to implement the PDCA (Plan-Do-Check-Act) cycle in hospital inpatient pharmacies to improve the management and compliance of the three-step analgesic ladder for cancer pain patients. Methods A mixed-methods study design combining retrospective and prospective components was employed. Retrospective data on prescription compliance for three-step analgesics were collected from June 2021 to March 2022 (pre-implementation). The prospective randomized cohort study enrolled 160 advanced cancer patients from June 2022 to March 2023 (intervention and control groups). Interventions included paperless prescription management, enhanced patient education, and structured follow-ups. Results The prescription compliance rate improved significantly from 72.32% before implementation to 92.92% after implementation ( P  < 0.05). Satisfaction rates among medical staff with the management process increased from 81.09 to 94.22%, indicating enhanced efficiency and accuracy. Satisfaction rates reflected healthcare professionals’ evaluation of improved prescription practices and reduced workload. Pain intensity, measured by the visual analog scale (VAS), decreased significantly in the intervention group compared to the control group (2.26 ± 0.78 vs. 3.07 ± 0.15; P  < 0.01). Conclusions The implementation of the PDCA cycle significantly improved compliance with the WHO three-step analgesic ladder, enhanced pain management outcomes, and increased satisfaction among healthcare professionals. Future studies should explore integrating patient-specific assessments to optimize individualized pain management strategies.

Introduction Preemptive multimodal analgesia (PMA) is commonly employed for pain control after total knee arthroplasty (TKA). However, the optimal timing for initiating PMA remains unclear. This study aimed to compare the efficacy of PMA administered at different time points before TKA. Materials and methods In this prospective, double-blind, placebo-controlled, randomized trial, 120 patients who underwent TKA were randomized into three groups. PMA (200 mg celecoxib and 150 mg pregabalin administered every 12 h) was initiated 48 h (group A), 24 h (group B), and 1 h (group C) before surgery. The primary outcome was the postoperative administration of morphine hydrochloride as a rescue analgesic. Secondary outcomes included time to first rescue analgesia, postoperative pain assessed using the visual analog scale (VAS), functional recovery assessed by knee motion range and ambulation distance, time until hospital discharge, and complication rates. Results Compared with group C, groups A and B exhibited significantly lower morphine consumption within 24 h after surgery, lower total morphine consumption, longer time to first rescue analgesia, and superior range of knee motion on the day of surgery. Groups A and B did not exhibit significant differences in these outcomes. The three groups did not differ significantly in postoperative VAS pain scores, ambulation distance, length of hospital stay, or complication rates. Conclusions In comparison with PMA starting at 1 h preoperatively, initiating PMA at 24 and 48 h preoperatively provided better postoperative pain relief. Considering the aim of minimizing the amount of ineffective medication received by patients, initiating PMA at 24 h preoperatively may be a more favorable option for patients undergoing TKA. However, the clinical significance of our results and the optimal starting time for PMA require further investigation.

This randomized, controlled study compared the efficacy and safety between oxycodone–paracetamol tablet and celecoxib for postoperative analgesia in patients who underwent arthroscopic knee surgery (AKS). Totally, 232 patients scheduled to undergo AKS were enrolled and were randomly assigned to either the oxycodone–paracetamol (OPT group) or the celecoxib group (CEL group). Pain at rest/motion (based on pain visual analog scale (VAS) score), rescue analgesia consumption, satisfaction level and adverse events were assessed after AKS. Pain VAS score at rest was decreased at 6 h, 12 h post-AKS in the OPT group compared with the CEL group. Similarly, pain VAS score at motion was reduced at 6 h, 12 h, 24 h post-AKS in the OPT group compared to the CEL group. Furthermore, both rescue analgesia rate (14.7% vs . 33.6%) and accumulated pethidine consumption (3.7 ± 8.9 mg vs . 14.0 ± 21.2 mg) were lower in OPT group compared with the CEL group. Patients satisfaction score was either at 24 h, 48 h in OPT group compared with the CEL group. Further subgroup analyses indicated that the effect of oxycodone–paracetamol versus (vs . celecoxib) on post-AKS management was more apparent in the elderly patients and male patients. In addition, the adverse events were well tolerable (including nausea, constipation, vomiting, drowsiness and dizziness) and were of no different between the two groups. In conclusion, oxycodone–paracetamol tablet presents increased analgesic efficacy for acute postoperative pain, with higher patient satisfaction and comparable safety profiles compared with celecoxib in patients underwent AKS.