Average Pain Score Research Articles

EVALUATION OF CLINICAL RESULTS OF SURGICAL RESECTION OF SYNOVIAL OSTEOCHONDROMATOSIS IN THE SHOULDER: A RETROSPECTIVE STUDY

Synovial osteochondromatosis of the shoulder is a rare condition and its details remains unclear. Aim of this study was to evaluate the clinical results of surgical resection and histopathological characteristic of SOC of the shoulder. Ten shoulders with SOC were retrospectively assessed for demographic characteristic, history of trauma, presence of osteochondral loose bodies, inferior humeral osteophytes and acromial spurs. Visual analog scores for pain and functional scores using Constant scores were compared pre and post operatively. Resected lesions were histo-pathologically differentiated between primary and secondary SOC. The average age of patients was 39.8+/- 15.7 year; four female and six patients was male in our study. Average duration of symptoms was 11.5+/-8.11 months. Three shoulders has osteochondral lesion in subacromial space (30%) and seven in glenohumeral joint (70%). Five shoulders (71%) show inferior humeral osteophytes out of seven shoulders with lesion in glenohumeral joint. All three shoulder (100%) with SOC in the subacromial space had spur formation. One shoulder have primary SOC while other nine had secondary SOC. Average Visual analog scale pain score graded from 0 (no pain) to 100 mm( maximal pain) was 47.5+/-11.32 mm. The Constant score was improved from preoperative score 51.6+/-8.34 points to postoperative score 78.7+/-11.62. No case show recurrence of new loose bodies, acromial spur and inferior humeral osteophytes. Our study showed that resection of SOC successfully relieved the pain and clinical symptoms. Primary SOC is less common than secondary SOC and histopathological identification is needed to differentiate between both types. Thus further investigations required to determine long term prognosis SOC in the shoulder. KEYWORDS: osteochondromatosis, shoulder joint, synovium

Clinical and Radiologic Outcomes after Cryoablation of Desmoid Tumors

Abstract Purpose This study aims to evaluate the impact of cryoablation on patients with desmoid tumors, considering both pain and functional impairment. Cryoablation has emerged as a promising intervention, primarily recognized for its ability to reduce radiological evidence of the neoplasm. However, the focus of this research is on assessing the clinical outcomes, recognizing the importance of improving patient-reported symptoms as additional evidence is required in this area to strengthen previous findings. Methods A retrospective study of 18 patients treated with cryoablation for desmoid tumors were included in this study. The evaluation of clinical status involved structured interviews to capture changes in pain and functional impairment. Pain scores and functional impairment scores were recorded on a 10-point Likert scale before and after the treatment. The correlation between these clinical findings and imaging was a key aspect of the investigation. Results Following cryoablation treatment, the average pain scores exhibited a notable decrease of 4.75 points on the 10-point Likert scale. Similarly, functional impairment scores demonstrated a significant average decrease of 4.0 points. Additionally, there was an overall decrease in viable tumor volume after ablation, correlating with the above findings. Conclusion This study provides evidence that cryoablation is effective in achieving clinically significant improvement in patients with desmoid tumors. While the reduction in radiological evidence is recognized, the emphasis of this study was on patient-reported outcomes, particularly in pain and functional impairment. These findings underscore that cryoablation is a valuable intervention in the comprehensive management of desmoid tumors improving overall quality of life.

Comparison of Pericapsular Nerve Group and Lateral Quadratus Lumborum Blocks for Analgesia after Primary Total Hip Arthroplasty: A Randomized Controlled Trial.

The quadratus lumborum block (QLB) and the pericapsular nerve group (PENG) block both provide effective postoperative analgesia after hip surgery while minimizing impact on motor function. This study aimed to compare QLB and PENG in patients undergoing primary total hip arthroplasty. This superiority trial randomized patients scheduled for elective total hip arthroplasty to receive a lateral QLB or PENG with lateral femoral cutaneous nerve blocks for postoperative analgesia. Perioperative analgesic protocols were standardized. The primary outcome was postoperative cumulative opioid consumption at 72 hours. Secondary outcome was postoperative pain scores. Additional outcomes of interest included time to first ambulation, length of stay, patient reported outcome measures, and opioid-related side effects. This trial consented and randomized 106 subjects and 101 were included in analysis: PENG (n=50), QLB (n=51). Mean (95% CI) opioid consumption (IV MME) in the first 72 hours did not differ between PENG [109.6 (93.6, 125.6)] and QL [92.3 (76.6, 107.9)] groups (p=0.129) There were no significant differences between treatment arms in average pain score, time to ambulation, distance ambulated, rate of same day discharge, or hospital length of stay. There were also no differences in patient reported outcomes using HOOS-JR and PROMIS-10 scores. Patients undergoing primary THA receiving preoperative PENG vs QLB had similar opioid consumption, pain scores, time to ambulation, and hospital length of stay. Both QL and PENG blocks are analgesic options in patients undergoing primary THA. NCT05710107; www.ClinicalTrial.gov IRB Protocol ID: Pro00124880. Pericapsular nerve group (PENG) block may provide analgesia after hip arthroplasty and improve early functional recovery. This study evaluated postoperative opioid consumption in patients randomized to PENG or lateral quadratus lumborum block (QLB).Opioid consumption, pain scores, motor recovery, and functional outcome measures did not differ in patients randomized to PENG vs lateral QLB.PENG and lateral QLBs are analgesic options following total hip arthroplasty with similar rates of same day discharge.

The role of vitamin D in amelioration of oral lichen planus and its effect on salivary and tissue IFN-γ level: a randomized clinical trial

Background and objectivesOral lichen planus (OLP) is a common, prevalent, immune-mediated, inflammatory disease affecting both the skin and oral mucosa and is considered one of the potentially malignant diseases. Since OLP is regarded as an immunologically mediated disease, some studies suggest the use of vitamin D (VD) for its management as it exhibits immune-modulatory, anti-inflammatory, and antimicrobial properties, as well as anti-proliferative, pro-differentiative, and anti-angiogenic effects. VD has demonstrated a suppressive effect on TH1 pro-inflammatory cytokines, including IFN-γ while augmenting the secretion of anti-inflammatory cytokines. At the same time, VD deficiency is a prevalent public issue. Therefore, the present study aimed to investigate the role of VD as an adjunct to steroids in the management of VD-deficient OLP patients as well as its inhibitory effect on IFN-γ through measurement of salivary and tissue IFN-γ levels in OLP patients.MethodsA total of 40 patients with ulcerative or erythematous OLP, diagnosed according to the World Health Organization’s (WHO) modified criteria for OLP, were randomly allocated into one of the two study groups to receive either systemic steroids in addition to VD supplements (Group A) or systemic steroids only (Group B). Blood samples were collected for the measurement of serum VD level (SVDL) using the enzyme-linked immunosorbent assay (ELISA) to involve only patients with VD deficiency or insufficiency (≤ 30 ng/ml). Clinical evaluation of the lesion involved objective signs and subjective symptoms. Also, changes in salivary and tissue INF-γ levels (in pg/mL and pg/mg, respectively) were determined using the ELISA technique. All parameters were measured at baseline and after 4 weeks of treatment. The clinical pharmacy team devised a checklist to record all team interventions. The interventions were categorized into six domains, including drug interactions and/or adverse reactions, medication dose issues, drug selection issues, support with medication history, patient-related concerns, and suggestions for dental medication.ResultsAfter one month of treatment, a significantly greater number of patients in group A showed complete pain relief and resolution of clinical lesions, as well as a greater number of patients showing a reduction in the clinical severity of lesions than in group B (P = 0.005). Also, there was a statistically significant reduction in average VAS pain scores and clinical scores in group A compared to group B after 1 month of treatment (P = 0.001 and 0.002, respectively). Furthermore, there was a statistically significant greater reduction in salivary and tissue IFN-γ levels in group A than in group B (P ≤ 0.001 and 0.029, respectively) after 1 month of treatment.ConclusionCurrent evidence suggests a significant preventive and therapeutic role for VD as an adjunct to standard therapies indicated for OLP lesions. These protective and therapeutic functions are achieved through the suppressive effect of VD on pro-inflammatory cytokines, particularly IFN-γ. Also, salivary IFN-γ appears to be a valuable prognostic marker for monitoring the progression of OLP. In addition, the inter-professional collaboration between dentists and clinical pharmacists helped to deliver complete, patient-centered primary care and ensured the quality of the medications included in patient kits, thus improving patient treatment and management. Nevertheless, further studies with larger sample sizes, longer follow-ups, and standardized designs may still be needed.

Complete elbow ankylosis secondary to heterotopic ossification: operative management leads to fair to excellent long-term outcomes

BackgroundHeterotopic ossification (HO) in the elbow, often caused by trauma or neurogenic factors, can lead to limited range of motion and physical impairment, while severe cases may result in debilitating loss of function. Complete bony ankylosis of the elbow, though rare, presents challenges in treatment due to complex anatomy and high recurrence rates, with limited literature on management and outcomes. This study retrospectively investigates cases of elbow ankylosis secondary to HO, assessing long-term functional outcomes following operative intervention and standardized rehabilitation. MethodsA retrospective case series was performed on patients who underwent surgical excision of heterotopic ossification of the elbow at our institution. Outcomes of interest were intraoperative flexion-extension arc, flexion-extension arc at final long-term postoperative follow-up, visual analog scale pain scores at long-term follow-up, and Mayo Elbow Performance Scores at long-term follow-up. Wilcoxon signed-rank test was performed to identify a statistically significant difference between arc of motion achieved intraoperatively and the arc of motion maintained at final long-term postoperative follow-up. ResultsBetween September 1999 and July 2021, 107 patients underwent operative resection for heterotopic ossification around the elbow, with 13 patients (16 elbows) exhibiting complete ankylosis at time of surgery. Patients were followed for a minimum of two years. Long-term outcomes demonstrated an average VAS pain score of 1.4 +/- 1.7, and an average MEPS of 85.9 +/-12.8, with 75% of cases maintaining at least 100 degrees of flexion-extension arc at final long-term postoperative follow-up. On average, the flexion-extension arc of motion at final follow-up was preserved at 95% of intraoperative levels. Patients did have an average residual flexion contracture of 18 +/- 9 degrees at final follow-up. ConclusionSurgical excision for complete elbow ankylosis secondary to heterotopic ossification presents challenges due to potential complications. Our study shows favorable long-term outcomes in pain scores, range of motion, and Mayo Elbow Performance Scores (MEPS). Despite reported complications in the literature, our series exhibited no adverse events, supporting operative excision as a standard treatment with overall fair to excellent outcomes. Further research, particularly involving multicenter, randomized, prospective studies, is warranted to refine protocols and understand predictors for improved outcomes in this patient population.

A sham-controlled, randomized trial of spinal cord stimulation for the treatment of pain in chronic pancreatitis.

Spinal cord stimulation (SCS) has emerged as a treatment option for patients with chronic pancreatitis (CP) who experience pain that does not respond to standard interventions. However, there is a lack of sham-controlled trials to support its efficacy. This randomized, double-blinded, sham-controlled, cross-over trial enrolled 16 CP patients with insufficient pain relief from standard therapies. Patients underwent high-frequency (1000 Hz) paraesthesia-free SCS or sham for two 10-day stimulation periods, separated by a 3-day washout period. The primary outcome was daily pain intensity registered in a pain diary based on a numeric rating scale (NRS). Secondary outcomes included various questionnaires. Quantitative sensory testing was used to probe the pain system before and after interventions. The average daily pain score on the NRS at baseline was 5.2 ± 1.9. After SCS, the pain score was 4.2 ± 2.1 compared to 4.3 ± 2.1 in the sham group (mean difference -0.1, 95% CI [-1.4 to 1.1]; P = 0.81). Similarly, no differences were observed between groups for the maximal daily pain score, secondary outcomes or quantitative sensory testing parameters. During an open-label, non-sham-controlled and non-blinded extension of the study, the average daily NRS was 5.2 ± 1.7 at baseline, 3.2 ± 1.8 at 3 months, 2.9 ± 1.9 at 6 months and 3.4 ± 2.2 at 12 months of follow-up (P = 0.001). In this first sham-controlled trial of SCS in painful CP, we did not find evidence of short-term pain relief with paraesthesia-free high-frequency (1000 Hz) stimulation. However, evaluation of the long-term effect by larger sham-controlled trials with long-term follow-up is warranted. In this first sham-controlled trial to apply high-frequency (1000 Hz) spinal cord stimulation in patients with visceral pain due to chronic pancreatitis, we did not find evidence for clinically relevant pain relief. Taken together with potential procedure-related complications, adverse effects and costs associated with spinal cord stimulation, our findings question its use for management of visceral pain.

Efficacy of EMLA for Office-based Andrology Procedures Under Local Anesthesia: A Randomized Control Trial

ObjectiveTo evaluate the effectiveness of Eutectic Mixture of Local Anesthetic (EMLA), a topical anesthetic cream, in office-based invasive andrological procedures such as hydrocelectomy, spermatocelectomy, and others, aimed at minimizing pain perception and enhancing the overall patient experience. MethodsA double-blinded randomized controlled trial was conducted for patients undergoing scrotal andrology surgeries under LA. Power calculation was performed with an estimated sample size of 72. Participants were randomly assigned in a 1:1 ratio to topical EMLA + LA vs LA alone. In the post-operative recovery area, patient will be asked to complete a VAS questionnaire rating pain with LA administration and pain with procedure. Analysis comparing VAS pain scores of both groups was performed using the independent sample t-test method. Results72 patients were included in our analysis, with 36 in the control and 36 in the intervention arm. For patient pain with administration of LA, the control arm reported an average VAS pain score of 4.31, compared to 3.72 in the intervention arm (p=0.319). For patient pain with procedure, patients in the control arm reported a median VAS pain score of 3.47 compared to 3.03 (p=0.432) in the intervention arm. Overall, 86% (62/72) of patients reported that they would either be “very likely” (4/5) or “highly likely” (5/5) to undergo future procedures under local anesthetic. ConclusionsWhile performing scrotal surgeries under LA appears to be well tolerated and a feasible option, the application of EMLA cream does not appear to significantly alter patient-reported outcomes.

Utilization and Evaluation of Analgesics in Post Gynecologic Operations: A Cross- Sectional Study

Background: This study evaluated the current practices of opioid and non-opioid analgesic administration for postoperative pain management in gynecological surgeries, aiming to optimize pain relief while minimizing side effects. Methods: A cross-sectional, prospective Drug Utilization Evaluation (DUE) study was conducted at Al-Zahra Hospital, Tabriz, Iran. Medical records of 100 patients undergoing gynecological surgery were reviewed over five months. Data on prescribed analgesics, pain scores, and adherence to APS2016 and ERAS2016 guidelines were collected and analyzed statistically. Results: Meperidine (pethidine) and diclofenac were the most frequently prescribed analgesics. The average patient pain score was 2.48 units. A combination of meperidine, diclofenac, and acetaminophen was identified as the most effective regimen for pain control. Prescribed regimens demonstrated 41.4±27.3% theoretical and 60.60 ± 28.77% practical compliance with APS2016 and ERAS2016 guidelines. While achieving the primary objective of pain relief with minimal side effects, compliance with established guidelines could be further improved through educational interventions. Conclusion: Optimizing analgesic regimens for postoperative pain management requires careful consideration of individual patient needs, including the benefits of opioid analgesics in achieving greater pain reduction. Adherence to evidence-based guidelines and ongoing educational programs for healthcare professionals are crucial for ensuring optimal pain relief with minimal side effects.

It is not the best option to perform transurethral enucleation of the prostate immediately after biopsy in patients with histological inflammation.

This study seeks to investigate the impact of histopathological evidence of histological prostatic inflammation (PI) on the surgical outcomes of patients with benign prostatic hyperplasia (BPH) undergoing transurethral bipolar enucleation of the prostate (BiLEP) after biopsy. We conducted a prospective study in which data were collected from 112 patients with BPH who underwent BiLEP immediately after prostate biopsy at the Department of Urology in our hospital between October 2020 and October 2023. This cohort included 52 patients with histopathological prostatic inflammation (BPH + PI group) and 60 patients with simple BPH (BPH group). Baseline characteristics, surgical details, International Prostate Symptom Score (IPSS), quality of life (QoL), post-void residual volume (PVR), maximum flow rate (Qmax), International Index of Erectile Function-5 (IIEF-5), postoperative pathology results, and surgical complications were compared between the two groups. The study findings indicate that in patients with BPH who underwent BiLEP, various parameters in the BPH + PI group including operation time, intraoperative flushing volume, hemoglobin drop value, postoperative white blood cells, postoperative C-reactive protein, and average pain score at 3 days postoperatively were significantly higher compared to those in the BPH group (p < 0.01). In addition, the IPSS and IIEF-5 scores of the BPH + PI group were significantly worse before surgery and at 2 weeks postoperatively compared to the BPH group (p < 0.01); however, no significant differences were observed between the two groups at 1 and 3 months postoperatively (p > 0.05). At 2 weeks postoperatively, the BPH + PI group exhibited significantly worse outcomes in terms of QoL, PVR, and Qmax compared to the BPH group (p < 0.01). However, there were no statistically significant differences between the two groups at 1 and 3 months postoperatively (p > 0.05). The incidence rates of postoperative complications, such as fever, prostatic capsule perforation, urinary tract irritation, bladder spasm, acute epididymitis, urinary tract infection, and urethral stricture, were higher in the BPH + PI group compared to the BPH group (p < 0.05). Nevertheless, there was no significant difference in the overall complication rates between the two groups (p > 0.05). There were no statistically significant differences observed between the two groups in postoperative irrigation volume, extubation time, hospitalization time, proportion of secondary operations, proportion of bladder injury, and proportion of urinary incontinence (p > 0.05). However, the proportion of reported prostate cancer after surgery in the BPH + PI group was significantly higher than that in the BPH group (p < 0.05). Histopathological prostatic inflammation does not have a significant impact on the long-term efficacy of BiLEP surgery immediately after biopsy. However, it does prolong surgery time, increase surgery-related complications, and influence short-term surgical outcomes and patient treatment experience. Therefore, it may be advisable to administer a course of anti-inflammatory treatment before performing BiLEP in such patients. Nevertheless, further high-quality studies are necessary to validate this approach.

Multiple Level Anterior Cervical Discectomy and Fusion with PEEK Cage without Plating: Clinical Outcomes

Abstract Background: Anterior cervical discectomy and fusion is a common procedure done to treat cervical disk disease. The role of plating in the treatment of multilevel disc disease in the absence of instability has been debated with some claiming no difference in the clinical outcomes. Objective: The aim of the study was to assess the long term clinical outcomes of patients who underwent two or three level discectomies with PEEK cage placement without plating. Material and Methods: We collected the required data of all patients. Patients were contacted and completed clinical outcome questionnaires including NDI and VAS-Neck. All data was tabulated and statistical analysis was done. Results: Data of 72 patients was collected. The average age of the patients was 52.73 years. The mean follow-up was 62.4 months. 37 patients presented with Myelopathy (51%), 24 with radiculopathy (33%), 11 with myeloradiculopathy. The average VAS scores for neck pain preoperatively was 6.29 (Range: 4–9) and postoperatively improved to an average of 3.18 (Range: 0–7). The average neck disability index preoperatively was 37.86 (Range: 28–47) and the average postoperative NDI score being 19.02 (Range: 9 to 28). Our patients had a preoperative mean mJOA score of 11.68 (Range:3–17) and a mean postoperative mJOA score of 14.66 (3–17) with a mean difference of 3 points. Conclusion: The clinical outcomes of multiple-level cervical fusion without plating and with plating are similar. The best surgical option is one that requires minimal disruption of normal tissue, simple in technique and provides the patient with immediate- and long-term relief.

Safety and perioperative outcomes of uniportal versus multiportal video-assisted thoracoscopic surgery.

Uniportal video-assisted thoracoscopic surgery (U-VATS) has recently become an alternative approach for many minimally invasive thoracic procedures, but although its surgical effectiveness has been proven, still its feasibility and safety are debated and unclear. the objective of this study was to compare the safety and perioperative outcomes of U-VATS versus multiportal VATS (M-VATS). This was a comparative follow-up randomised controlled clinical trial, carried out on 36 randomly selected eligible patients, and fulfilling the inclusion and exclusion criteria for VATS, they were assigned randomly into two groups: Study Group I including 18 patients undergoing U-VATS with conventional treatment using standard chest tube drainage and Control Group II including 18 patients undergoing M-VATS) with the same conventional treatment using standard chest tube drainage and served as a comparable control group. Patients in the U-VATS Group 1 had faster operation time, and with reduced blood loss, pleural drainage and post-operative hospitalisation, they also experienced lower average post-operative pain score on comparison with those in M-VATS Group II (P < 0.001), respectively. For either group, there were no hospital deaths or infections. There was no noticeable difference between the two groups in terms of the number of resected lymph nodes or the rates of intraoperative or post-operative complications (P > 0.05). U-VATS is feasible and safe in eligible selected patients with favourable short-term perioperative outcomes (operative time, duration of pleural drainage, post-operative pain, early ambulation, duration of hospital stay as well as the risk of perioperative complications), and it can be considered the preferred approach in minimally invasive thoracic procedures that open up for the possibility of fast-track thoracic surgeries.

The Effect of Effleurage Massage on the Level of Back Pain Scale in Trimester III Pregnant Women

Pregnancy is a physiological process that occurs in every woman in the reproductive phase. The growth and development of the fetus in the uterus can result in anatomical and physiological changes in pregnant women. The occurrence of back pain is caused by musculoskeletal changes. By providing massage therapy it is hoped that it can reduce the severity of back pain in third trimester pregnant women. This research used a pre-experimental design with a pretest-posttest with control group design. The sampling method used a purposive sampling technique, which took samples from third trimester pregnant women who experienced back pain in the Lubuk Bintialo Health Center Work Area. Data analysis used in this research was the T-test to determine the effect of effleurage massage on the level of the back pain scale. Based on research conducted, of the 18 respondents before receiving effleurage massage in the treatment group, the average maternal pain scale was 5.44, while in the control group it was 5.67. Meanwhile, after receiving effleurage massage, the treatment group experienced a significant decrease with a mean of 3.7 with a mean difference of 1.66 before being given effleurage massage. Meanwhile, in the control group, the average result was 5.56 with a mean difference of 0.11. The results of bivariate analysis using the T-test obtained sig results. 0.000 &lt; 0.05 indicates that there is an influence of effleurage massage on the back pain scale level of pregnant women in the third trimester. Thus, the application of effleurage massage can be used as an alternative treatment to reduce back pain in third trimester pregnant women by doing it according to the procedure.

Assessing the Influence of Patient Anxiety on the Efficacy of Endodontic Procedures.

Patient anxiety is known to influence various aspects of dental procedures, including endodontic treatments. However, the extent of its impact on the efficacy of such procedures remains uncertain. Understanding this influence is crucial for improving patient outcomes and optimizing treatment protocols. A prospective cohort study was conducted involving 100 patients undergoing endodontic procedures. Patient anxiety levels were assessed using standardized anxiety scales before and after treatment. The efficacy of endodontic procedures was evaluated based on posttreatment pain scores, success rates of root canal treatments, and patient-reported satisfaction levels. The mean pre-treatment anxiety score was 45.7 (SD = 9.2), while the mean posttreatment anxiety score reduced significantly to 32.4 (SD = 7.6), indicating a significant reduction in anxiety levels following endodontic procedures (P < 0.001). Posttreatment pain scores were lower in patients with reduced anxiety levels, with an average pain score of 2.1 (SD = 1.3) compared to 3.8 (SD = 1.6) in patients with persistently high-anxiety levels (P = 0.002). Additionally, the success rate of root canal treatments was higher in patients with lower anxiety levels (85%) than those with higher anxiety levels (65%) (P = 0.015). Overall patient satisfaction was also significantly higher in the low-anxiety group (P < 0.001). Patient anxiety significantly influences the efficacy of endodontic procedures, affecting posttreatment pain, success rates of root canal treatments, and patient satisfaction levels. Efforts to reduce patient anxiety before and during endodontic procedures may lead to improved treatment outcomes and higher patient satisfaction.

The Effect of Music Therapy on the Pain Level of 3 to 6-year-old Children Undergoing Wound Repair by Suturing and Their Parents' Anxiety in the Emergency Department: A Randomized Controlled Trial

Background: Music can serve as a passive distraction to reduce pain and anxiety. Due to the limited number of studies in this field, a study was designed and implemented to determine the effect of music therapy on the pain level of 3 - 6-year-old children undergoing wound repair by suturing and their parents' anxiety in the emergency department. Objectives: This study aimed to examine the effect of music therapy on the pain level of 3 to 6-year-old children undergoing wound repair by suturing and their parents' anxiety in the emergency department. Methods: The present study is a parallel, controlled, randomized clinical trial. Sixty children aged 3 to 6 years referred to the emergency room for sutures were included in the study. In the test group, music was played on a mobile phone from the time the child entered the outpatient operating room until the end of the procedure and discharge. In the control group, children were sutured as usual. The behavioral reactions of both groups were assessed using Wong-Baker's pain scale before washing the wound, immediately after the injection of lidocaine, and at the end of the suture. The abbreviated Spielberger Situational Anxiety Questionnaire was used to measure parents' anxiety before washing the wound and at the end of the suture. These measures were recorded by the researcher. Results: Comparing the mean (standard deviation) of pain before washing the wound in the test group (9.90 ± 0.44) and the control group (9.97 ± 0.258) showed no statistically significant difference (P = 0.311). Using the GEE model, the average pain score immediately after lidocaine injection and at the end of the suture decreased by 1.77 and 4.9 units, respectively, compared to the phase before washing the wound (P &lt; 0.001). The average anxiety of parents before washing the wound was 21.05 ± 2.59 in the test group and 21.05 ± 2.09 in the control group, showing no statistically significant difference (P = 0.801). Conclusions: Based on the results of this study, there was no statistically significant difference between the two groups in terms of children's pain and parents' anxiety. However, clinically, the average levels of children's pain and parents' anxiety in the intervention group decreased at all three times. Music therapy seems to be effective in the emergency department during painful procedures.

Use of regional anesthesia within a pediatric interventional radiology suite reduced periprocedural opioid use without delaying the overall workflow: a retrospective study

BackgroundNerve block utility has been extensively described in the operating room, however, there is a paucity of evidence regarding blocks in the interventional radiology (IR) suite, with no studies examining...

Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study.

Up to 50% of diabetic patients with neuropathy suffer from chronic pain, namely painful diabetic neuropathy (PDN), an unmet medical need with significant impact on quality of life. Gabapentin is widely used for PDN, albeit with frequent dose-limiting effects. Trazodone, an antidepressant with multi-modal action, has shown promising results when given at low doses as an add-on to gabapentin. Upon previous clinical trials and experimental evidence, a fixed-dose combination (FDC) of both compounds, at low doses, was developed for neuropathic pain. This was a phase II, randomized, double-blind, placebo and reference controlled, dose-finding, multicenter, international, prospective study. Male and female diabetic patients aged 18-75years and affected by PDN were eligible for enrolment. Patients were randomized (1:1:1:1:2 ratio) to trazodone and gabapentin (Trazo/Gaba) 2.5/25mg t.i.d. for 8weeks, Trazo/Gaba 5/50mg t.i.d. for 8weeks, Trazo/Gaba 10/100mg t.i.d. for 8weeks, gabapentin (Gaba), or placebo (PLB). The aim of the study was to collect preliminary information on the effect of the 3 different FDCs of Trazo/Gaba on pain intensity based on the 11-point numeric rating score (NRS) after 8weeks of treatment. The secondary objectives were the evaluation of the percentage of responders, neuropathic pain symptoms, anxiety, sleep, quality of life, safety, and tolerability. The primary efficacy endpoint was evaluated with last observation carried out forward (LOCF), using an analysis of covariance (ANCOVA), including treatment and centers as factors and baseline as covariate and applying linear contrast test, excluding the active treatment. Only if the linear contrast test was significant (p < 0.05), the step-down Dunnett test would be used to determine the minimum effective dose significantly different from PLB. If linearity was not verified, an adjusted ANCOVA model and comparisons with Dunnett test were performed. Before the application of the ANCOVA model, the non-significance of interaction treatment per baseline was verified. A total of 240 patients were included in the modified intention-to-treat (m-ITT) population: 39 in Trazo/Gaba 2.5/25mg, 38 in Trazo/Gaba 5/50mg, 37 in Trazo/Gaba 10/100mg, 83 in PLB, and 43 in Gaba. After 8weeks of treatment, changes of the average daily pain score based on the 11-point NRS from baseline were - 2.52 ± 2.31 in Trazo/Gaba 2.5/25mg group, - 2.24 ± 1.96 in Trazo/Gaba 5/50mg group, - 2.46 ± 2.12 in Trazo/Gaba 10/100mg group, - 1.92 ± 2.21 in Gaba group, and - 2.02 ± 1.95 in the PLB group. The linear contrast test did not result in significant differences (p > 0.05) among treatment groups. Consequently, the minimum effective dose against PLB was not determined. The multiple comparison with Dunnett adjustment did not show any statistically significant differences vs. PLB after 8weeks of treatment: Trazo/Gaba 2.5/25mg (95% confidence interval (CI) - 1.2739, 0.2026; p = 0.1539); Trazo/Gaba 5/50mg (95% CI - 0.9401, 0.5390; p = 0.5931); Trazo/Gaba 10/100mg (95% CI - 1.0342, 0.4582; p = 0.4471). However, patients receiving the lowest dose of Trazo/Gaba 2.5/25mg showed a statistically significant difference to PLB after 6weeks of treatment (95% CI - 1.6648, - 0.2126; p = 0.0116). Positive results were also found for responder patients, other items related to the pain, anxiety, depression, sleep, and quality of life, consistently in favor to the lowest Trazo/Gaba FDC. Two serious adverse events (SAEs) occurred but were judged unrelated to the study treatment. Treatment-emergent adverse events (TEAEs) were mainly mild-to-moderate in intensity and involved primarily nervous system, gastrointestinal disorders, and investigations. The primary end point of the study was the change from baseline of the average daily pain score based on the 11-point NRS after 8weeks of treatment. While the primary endpoint was not reached, patients treated with Trazo/Gaba 2.5/25mg t.i.d. showed statistically significant improvement of pain and other scores after 6weeks and reported consistent better results in comparison to PLB on primary and secondary endpoints for the overall study duration. According to these results, the lowest dose of Trazo/Gaba FDC may be the best candidate for further clinical development to confirm the potential benefits of the FDC drug for this condition. NCT03749642.

Efficacy, Quality of Life, and Safety of Canacea in Palliative Cancer Patients

Background: Cancer is an important health problem in Thailand and all over the world. Cancer patients usually receive standard treatments, which causes adverse events. The advanced-stage cancer patients may not be responsive to treatments; therefore, supportive or palliative care is usually required. Canacea is a traditional medicine consisting of herbs with antioxidant and antimutagenic activities. Objective: To determine the efficacy, quality of life (QoL), and safety of Canacea in advanced-stage cancer patients. Materials and Methods: The present study was conducted at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand between January 2020 and March 2022. All patients received Canacea with supportive care medications. The performance status, pain control, and QoL were measured 24 weeks after Canacea treatment by using The Eastern Co-operative Oncology Group (ECOG), the Palliative Performance Status (PPS), the pain score, and the World Health Organization Quality of Life Brief - Thai (WHOQOL-BREF-THAI), respectively. Results: Seventeen patients were enrolled in the present study. The average age was 64.29±9.14 years, with eleven males and six females. At 24 weeks, the average pain score was 0.33±0.47 (range of 0 to 1) which was mild pain. The average ECOG and PPS were 1.7±0.75 (range of 1 to 3) and 70±18.26% (range of 40 to 90), respectively, which reflected a stable health status. The total QoL score from WHOQOL-BREF-THAI was 94.5±8.44 (range of 78 to 105), which reflected a moderate-to-high QoL. The safety outcome was monitored throughout the study using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Eleven patients developed adverse events, with four patients who had to withdraw from Canacea (23.53%). Conclusion: The treatment of Canacea with other supportive care showed a moderate-to-high score of pain control, health status, and QoL. Particularly, the total QoL showed an improvement after 24 weeks of treatment and the patients tended to have a better QoL.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain.

There is no approved effective drug for diabetic peripheral neuropathic pain (DPNP) in China. Gabapentinoids including mirogabalin have shown promise, although data in Chinese patients are scarce. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of mirogabalin for treating DPNP in China. Mirogabalin was administered at 5mg twice daily for the first week and uptitrated to 15mg twice daily for a total duration of 14weeks. The primary efficacy endpoint was the change from baseline in weekly average daily pain score (ADPS) at week 14; secondary endpoints included the ADPS responder rate, Short-Form McGill Pain Questionnaire visual analogue scale score, patient global impression of change (PGIC), average daily sleep interference score (ADSIS), EuroQol 5-dimensions 5-levels (EQ-5D-5L), and incidence of treatment-emergent adverse events (TEAEs). Of 393 patients (mirogabalin, n = 196; placebo n = 197), the mean age was 58.2years (mirogabalin, 58.7years; placebo, 57.7years) and 54.2% were male (mirogabalin, 56.1%; placebo, 52.3%). Mirogabalin elicited a greater change from baseline in the weekly ADPS vs. placebo at week 14: least-squares mean difference (95% confidence interval) vs. placebo - 0.39 (- 0.74, - 0.04), p = 0.0301. PGIC, ADSIS, and EQ-5D-5L data reflected significantly better improvements for patients receiving mirogabalin vs. placebo. The incidence of TEAEs was 75.0% and 75.1% in the mirogabalin and placebo groups, respectively. Most TEAEs were mild or moderate, and the incidence of TEAEs leading to treatment discontinuation was 2.6% in the mirogabalin group and 1.5% in the placebo group. Although the effect size of mirogabalin was reduced due to the placebo effect, mirogabalin is a safe and effective treatment option for Chinese patients with DPNP. ClinicalTrials.gov identifier, NCT04094662.

Efficacy and Safety of LX9211 for Relief of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1): Results of a Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study.

To evaluate the efficacy of LX9211 in reducing pain related to diabetic peripheral neuropathy. In this double-blind, multicenter, proof-of-concept trial, 319 individuals with diabetic peripheral neuropathic pain (DPNP) were randomized (1:1:1) to LX9211 10 mg (n = 106), LX9211 20 mg (n = 106), or matching placebo (n = 107), administered once daily for 6 weeks. DPNP was rated daily with an 11-point numerical rating scale. The primary end point was change from baseline to week 6 in the average daily pain score. The difference between each LX9211 group and placebo was evaluated with mixed-model repeated-measures analysis. For those on low-dose LX9211 the primary efficacy end point was achieved: -1.39 vs. -0.72 points for placebo, least squares mean (SE) difference -0.67 (0.249), 95% CI -1.16 to -0.18, P = 0.007; results for high-dose LX9211 demonstrated improvement in pain severity versus placebo (-1.27 vs. -0.72 points, respectively), but the between-group LS mean difference did not reach the prespecified statistical significance (-0.55 [0.254], 95% CI -1.06 to -0.05, P = 0.030). Treatment benefit was observed beginning at week 1 and maintained thereafter. Results for LX9211 also demonstrated improvement in several patient-reported secondary outcomes. Most common adverse events (AEs) were dizziness, nausea, and headache. More participants treated with LX9211 (20 mg, n = 28 [26.4%]; 10 mg, 17 [16.0%]) than placebo (3 [2.8%]) discontinued study drug prematurely due to AEs; serious AEs were uncommon (2 [1.9%], 0, and 1 [0.9%], respectively). These preliminary findings of improvement in DPNP with LX9211 support further investigation in larger trials.

Exploring the Efficacy of Biologics in Knee Osteoarthritis: Ultrasound Evaluation of Cartilage Regeneration Effects.

Biologics like growth factors, stem cells, and platelet-rich plasma show potential in stimulating cartilage regrowth and reducing inflammation. By synthesizing preclinical and clinical studies, this study offers insights into how these biologics work and their effectiveness in treating knee osteoarthritis. Twenty-four participants with knee osteoarthritis (Kellgren - Lawrence grade II or III) were enrolled after obtaining consent. They received three doses of 2ml intraarticular platelet-rich plasma at 1month intervals. The clinical assessment involved the oxford knee score (OKS) and visual analogue scale (VAS) for pain on Days 0, 90, and 180. Ultrasound measured femoral and trochlear cartilage thickness pre- (Day 0) and post-PRP (Day 90-180). Before treatment, the average pain score was 7.2 (p = 1.03). On Day 90 post-PRP, it decreased to 5 (p = 0.81), and by Day 180, it further reduced to 4.5 (p = 0.97). The initial total OKS was 33.5 (p = 1.76), which increased to 36 (p = 1.71) on Day 90 and 38.5 (p = 1.89) on Day 180. The femoral and trochlear cartilage thickness also showed improvement from baseline (0.92) to Day 90 (0.96) and Day 180 (1.01), indicating significant cartilage healing post-PRP administration. Our study highlights the probability of PRP in treating knee OA, highlighting their ability to alleviate symptoms, enhance joint function, and promote articular cartilage regeneration.