A Cross-Sectional Survey on Pain Management in Dermal Filler Injections from Physicians' and Patients' Perspectives.

BACKGROUND: Hyaluronic acid (HA) dermal fillers injection is a common procedure in patients with cosmetic needs. Concomitant pain is a major complaint among patients undergoing HA filler injections. Relevant research is limited and there is no consensus on pain management of dermal filler injection. OBJECTIVES: To assist physicians in determining a more appropriate treatment approach, and to better provide treatment suggestions. METHODS: A nationwide (China) cross-sectional survey was conducted using questionnaires designed for physicians and patients, respectively. A total of 62 semi-structured questionnaires were administered to aesthetic physicians via face-to-face interview, whereas 123 online-based questionnaires were collected from patients who have ever undergone HA treatment. The collected questionnaire information was analyzed using descriptive statistics and content analysis. RESULTS: 42 (67.74%) physicians observed that over 50% of their patients were concerned about pain during injection. 101 (82.11%) of patients were concerned about impending pain ≥5 points (a total score is 10) before injection. For preferred pain relief modalities, 48 (77.42%) physicians would choose a hyaluronic acid dermal filler with lidocaine, and 82 (66.67%) patients would choose anesthetic-containing products. 59 (95.16%) physicians who injected lidocaine-containing hyaluronic acid found patients had a comfortable treatment experience. CONCLUSIONS: Pain management during hyaluronic acid dermal fillers injection is important from both perspectives of physicians and patients. This survey showed that compared with other analgesic methods, lidocaine-containing hyaluronic acid has offered a more satisfying experience. It also provides insights to physicians and patients in pain management. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Evaluation of procedural pain for neonates in a neonatal intensive care unit: a single-centre study.

BACKGROUND: To evaluate the procedural pain experienced by neonates in a neonatal intensive care unit (NICU) setting and determine the corresponding pain grades. METHODS: Two experienced nurses independently used the Neonatal Infant Pain Scale (NIPS) to evaluate the neonatal pain during procedures taking place in the tertiary NICU and two level-two neonatal care units in the Children's Hospital of Zhejiang University School of Medicine. The mean and distribution of NIPS pain scores and the corresponding pain grades of participants when experiencing clinical painful procedures were analysed. RESULTS: A total of 957 neonates exposed to 15 common clinical painful procedures were included in the study. The clinical painful procedures experienced by 957 participants could be divided into three groups: severe pain (NIPS score 5-7: peripheral intravenous cannulation, arterial catheterisation, arterial blood sampling, peripherally inserted central catheter placement and nasopharyngeal suctioning), mild to moderate pain (NIPS score 3-4: finger prick, intramuscular injection, adhesive removal, endotracheal intubation suctioning, heel prick, lumbar puncture and subcutaneous injection) and no pain to mild pain (NIPS score 0-2: gastric tube insertion, enema and intravenous injection). CONCLUSIONS: The neonatal pain response to clinical procedures in NICU had certain pattern and preintervention drug analgesia could be taken for painful procedures with clustered high NIPS pain scores. Meanwhile, full coverage non-drug pain relief measures could be taken for procedures that are with scattered pain scores, and real-time pain evaluation should be provided to determine whether further drug analgesia is required.

ALPS-Neo pain and stress assessment scale for neonates-A measure for procedural pain.

AIM: The aim of this study was to investigate psychometric properties, reliability and validity, of Astrid Lindgren and Lund Children's Hospitals Pain and Stress Assessment Scale for Preterm and Sick Newborn Infants (ALPS-Neo), as a measure for procedural pain. METHODS: This observational, prospective study with a repeated measures design, explored inter-rater reliability by two raters assessing 21 neonates during non-pain and pain events. Construct validity was explored, that is, ability to discriminate between non-pain and pain, and criterion validity by correlating ALPS-Neo with Premature Infant Pain Profile-Revised (PIPP-R) and Skin Conductance Algesimeter (SCA) in 54 neonates without ventilator support and sedation undergoing routine heel-stick procedure in a tertiary neonatal intensive care unit. RESULTS: Mean gestational and assessment age of 54 infants was 33.8 weeks and 12.7 days respectively. Inter-rater reliability from baseline, skin wiping, heel-stick events for 21 infants demonstrated intraclass correlations with 95% confidence intervals (CI) of 0.49 (-0.27 to 0.79), 0.86 (0.65-0.94) and 0.73 (0.34-0.89) respectively. ALPS-Neo discriminated significantly between baseline, non-pain and heel-stick (mean differences from pain event -2.3 and -1.0 respectively) and correlated during heel-stick with PIPP-R (r = 0.56, 95% CI: 0.34-0.72), not with SCA. CONCLUSION: ALPS-Neo may be used as a measure for procedural pain.

Effects of an Immersive Virtual Reality Intervention on Pain and Anxiety Among Pediatric Patients Undergoing Venipuncture: A Randomized Clinical Trial.

Importance: Venipuncture is one of the most painful and distressing procedures experienced by pediatric patients. Emerging evidence suggests that providing procedural information and distraction using immersive virtual reality (IVR) may reduce pain and anxiety among children undergoing needle-related procedures. Objectives: To examine the effects of IVR on reducing the pain, anxiety, and stress experienced by pediatric patients undergoing venipuncture. Design, Setting, and Participants: This 2-group randomized clinical trial recruited pediatric patients aged 4 to 12 years undergoing venipuncture from a public hospital in Hong Kong between January 2019 and January 2020. Data were analyzed from March to May 2022. Interventions: Participants were randomly allocated to an intervention (an age-appropriate IVR intervention offering distraction and procedural information) or a control (standard care only) group. Main Outcomes and Measures: The primary outcome was child-reported pain. Secondary outcomes included child-reported anxiety, heart rate, salivary cortisol, length of procedure, and satisfaction of health care professionals with the procedure (rated on a 40 point scale, with higher scores indicating greater satisfaction). Outcomes were assessed 10 minutes before, during, immediately after, and 30 minutes after the procedure. Results: A total of 149 pediatric patients were recruited, with 86 female patients (57.7%) and 66 patients (44.3%) diagnosed with fever. Compared with the 74 participants in the control group (mean [SD] age, 7.21 [2.49] years), the 75 participants in the IVR group (mean [SD] age, 7.21 [2.43] years) reported significantly less pain (ß = -0.78; 95% CI, -1.21 to -0.35; P < .001) and anxiety (ß = -0.41; 95% CI, -0.76 to -0.05; P = .03) immediately after the intervention. Health care professional satisfaction in the IVR group (mean [SD] score, 34.5 [4.5]) was significantly higher than that in the control group (mean [SD] score, 32.9 [4.0]; P = .03). Moreover, the length of venipuncture procedure in the IVR group (mean [SD] duration, 4.43 [3.47] minutes) was significantly shorter than that in the control group (mean [SD] duration, 6.56 [7.39] minutes; P = .03). Conclusions and Relevance: In this randomized clinical trial, integrating procedural information and distraction in an IVR intervention for pediatric patients undergoing venipuncture significantly improved pain and anxiety in the IVR group compared with the control group. The results shed light on the global trends of research on IVR and its clinical development as an intervention for other painful and stressful medical procedures. Trial Registration: Chinese Clinical Trial Registry identifier: ChiCTR1800018817.

The Clinical Suitability of an Artificial Intelligence-Enabled Pain Assessment Tool for Use in Infants: Feasibility and Usability Evaluation Study.

BACKGROUND: Infants are unable to self-report their pain, which, therefore, often goes underrecognized and undertreated. Adequate assessment of pain, including procedural pain, which has short- and long-term consequences, is critical for its management. The introduction of mobile health-based (mHealth) pain assessment tools could address current challenges and is an area requiring further research. OBJECTIVE: The purpose of this study is to evaluate the accuracy and feasibility aspects of PainChek Infant and, therefore, assess its applicability in the intended setting. METHODS: By observing infants just before, during, and after immunization, we evaluated the accuracy and precision at different cutoff scores of PainChek Infant, which is a point-of-care mHealth-based solution that uses artificial intelligence to detect pain and intensity based solely on facial expression. We used receiver operator characteristic analysis to assess interpretability and establish a cutoff score. Clinician comprehensibility was evaluated using a standardized questionnaire. Other feasibility aspects were evaluated based on comparison with currently available observational pain assessment tools for use in infants with procedural pain. RESULTS: Both PainChek Infant Standard and Adaptive modes demonstrated high accuracy (area under the curve 0.964 and 0.966, respectively). At a cutoff score of ≥2, accuracy and precision were 0.908 and 0.912 for Standard and 0.912 and 0.897 for Adaptive modes, respectively. Currently available data allowed evaluation of 16 of the 17 feasibility aspects, with only the cost of the outcome measurement instrument unable to be evaluated since it is yet to be determined. PainChek Infant performed well across feasibility aspects, including interpretability (cutoff score defined), ease of administration, completion time (3 seconds), and clinician comprehensibility. CONCLUSIONS: This work provides information on the feasibility of using PainChek Infant in clinical practice for procedural pain assessment and monitoring, and demonstrates the accuracy and precision of the tool at the defined cutoff score.

Assessment of salivary cortisol concentrations for procedural pain monitoring in newborns.

OBJECTIVES: The study aimed to evaluate the usefulness of salivary cortisol (SC) for the assessment of procedural pain intensity in preterm and term newborns. METHODS: Three groups of neonates (term, 370-416 weeks; moderate to late preterm, 320-366; and very preterm, <320) hospitalized in neonatal intensive care unit were assessed for the study. Response to nappy change, lung ultrasound (LUS), and blood sampling was analyzed. The intensity of pain was evaluated using continuous heart rate and blood oxygen saturation (SpO2) monitoring, Neonatal Infant Pain Scale (NIPS), and SC concentrations. Saliva samples were collected before and 20 min after the procedure's end. RESULTS: Seventy-one infants were examined: 30 term, 21 moderate to late preterm, and 20 very preterm. SC has increased significantly in response to nappy change only in very preterm newborns (2.13 ng/mL [1.55-3.68] vs. 2.84 ng/mL [1.93-9.06], p = 0.01). LUS did not affect concentrations of SC in any group. Significant increase in SC was observed after blood sampling in term and very preterm infants (2.2 ng/mL [1.45-2.92] vs. 4.29 ng/mL [3.88-5.73], p = 0.002, and 1.88 ng/mL [1.47-4.13] vs. 5.3 ng/mL [3.42-8.02], p = 0.002, respectively). A significant correlation between values of SC increase and NIPS scores was found (Spearman's rank correlation coefficient [rs] = 0.31, p = 0.001). CONCLUSIONS: We observed the increase in SC concentrations in response to painful stimulus. The presence of a correlation between NIPS scores and SC increase suggests that SC can be used as an objective parameter to assess pain in neonates.

Effect of a Virtual Reality Environment Using a Domed Ceiling Screen on Procedural Pain During Intravenous Placement in Young Children: A Randomized Clinical Trial.

Importance: Distraction using virtual reality (VR) has been found to provide a clinically significant reduction in the experience of pain during various painful procedures. Commercially available VR systems usually require the user to wear a head-mounted display helmet, which can be challenging for young children, and whether VR can reduce pain during intravenous (IV) placement in young children is currently unknown. Objective: To determine whether a VR environment using a novel domed ceiling screen reduces distress among children over the course of IV placement compared with standard care in a pediatric emergency department. Design, Setting, and Participants: This randomized clinical trial was conducted from June 3, 2020, to February 8, 2021, at an urban tertiary academic children's hospital. Included were children aged 6 months to 4 years undergoing IV placement in the pediatric emergency department. Intervention: Children in the intervention group lay on a bed to experience a VR animation using a domed ceiling screen during the IV placement procedure, which was performed as usual. Children in the control group also lay on a bed during the procedure but did not view a VR animation. Main Outcomes and Measures: The primary outcome was pain scores measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 4 time points during IV placement: immediately after the child lay down on the bed (T1), the moment the tourniquet was applied (T2), the moment a sterile alcohol swab was applied (T3), and the moment the needle penetrated the skin (T4). Results: Of the 88 children included in the final analysis, 44 received VR distraction (median [IQR] age, 24.0 [14.5-44.0] months; 27 boys [61.4%]), and 44 received standard care (median [IQR] age, 23.0 [15.0-40.0] months; 26 boys [59.1%]). The median [IQR] FLACC scores at T4 were 6.0 (1.8-7.5) in the intervention group and 7.0 (5.5-7.8) in the control group. The ordinal logistic regression model showed that children in the VR intervention group vs the control group had a lower probability of higher FLACC scores (odds ratio, 0.53; 95% CI, 0.28-0.99; P = .046). Conclusions and Relevance: The findings of this trial indicate that displaying VR using a domed ceiling screen may be an effective distraction method that reduces distress in young children undergoing IV placement. Trial Registration: isrctn.org Identifier: KCT0005122.

Como avaliar a dor sentida por crianças pré-escolares durante os procedimentos odontológicos? revisão de escopo / How to evaluate the pain felt by preschool children during dental procedures? scope review

Introdução: o diagnóstico da dor sentida pela criança é um passo importante para orientar o cirurgião-dentista sobre o uso de técnicas farmacológicas e não farmacológicas que minimizem a sensação desagradável. Objetivo: identificar os instrumentos usados para a avaliação da dor de crianças pré-escolares durante procedimentos odontológicos. Fontes dos dados: busca por artigos foi realizada no PubMed, Scopus, The Cochrane Library e Google Schoolar, em abril/2022. Estudos observacionais e de intervenção que avaliaram a dor de crianças pré- escolares em atendimento odontológico, publicados em português, inglês ou espanhol foram incluídos. Estudos que avaliaram a dor de crianças tratadas sob sedação ou anestesia geral, bem como a dor pós-operatória, foram excluídos. Síntese dos dados: um total de 767 artigos foram identificados; 133 artigos foram lidos integralmente e 62 incluídos. Em 48 estudos, a dor foi avaliada por meio de autorrelato, usando instrumentos como a Wong-Baker FACES Pain Rating Scale e outras escalas de faces como a Faces Pain Scale-Revised e a Faces Pain Scale. Quando a dor foi avaliada a partir do comportamento infantil, foram usadas escalas como a Face, Legs, Activity, Cry, Consolability Scale (FLACC) e a Sound, Eye and Motor scale (SEM). Conclusão: a dor processual das crianças foi avaliada por meio de autorrelato e da observação do seu comportamento. Tanto as escalas de autorrelato quanto as observacionais têm limitações. A combinação dos instrumentos pode ser uma estratégia na avaliação da dor de pré-escolares.

Introduction: the diagnosis of the pain felt by the child is an important step to guide the dentist on the use of pharmacological and non-pharmacological techniques that minimize unpleasant sensation. Objective: to identify the instruments used to assess the pain of preschool children during dental procedures. Sources of Data: search for articles was conducted at PubMed, Scopus, The Cochrane Library and Google Schoolar in April/2022. Observational and interventional studies that evaluated the pain of preschool children in dental care, published in Portuguese, English or Spanish were included. Studies evaluating the pain of children treated under sedation or general anesthesia, as well as postoperative pain, were excluded. Synthesis of data: a total of 767 articles were identified; 133 articles were read in full and 62 included. In 48 studies, pain was evaluated by self-report, using instruments such as the Wong-Baker FACES Pain Rating Scale and other face scales such as the Faces Pain Scale-Revised and the Faces Pain Scale. When pain was evaluated from child behavior, scales such as Face, Legs, Activity, Cry, Consolability Scale (FLACC) and Sound, Eye and Motor scale (SEM) were used. Conclusion: the procedural pain of the children was evaluated by self-report and the observation of their behavior. Both self-report and observational scales have limitations. The combination of the instruments can be a strategy in the evaluation of the pain of preschoolers.

Parasympathetic evaluation for procedural pain assessment in neonatology.

INTRODUCTION: The Newborn Infant Parasympathetic Evaluation (NIPE) index is an instrument that enables continuous, fast and objective assessment of neonatal discomfort. The aim of the study was to analyse changes in NIPE values after performance of blood draws and the factors involved in this variation. MATERIAL AND METHODS: We conducted a prospective observational study. We included infants admitted to the neonatal intensive care unit between June and December 2021 who underwent blood draws. We recorded demographic data, aspects related to the procedure, the NIPE index and the heart rate at baseline and 1, 2, 3, 4, 5, 10 and 15 min after the procedure. RESULTS: The study included 86 records for 49 patients. In the first 4 min after the procedure, there was a significant decrease in the NIPE index, with a maximum decrease of 22.8% relative to baseline and the nadir at 2.79 min. The decrease in NIPE values was greater in infants born preterm, male, with lower 5-min Apgar scores and following procedures that had been performed previously, after caesarean section or in the morning. There were no differences when the blood draw was obtained during kangaroo care. The correlation between the NIPE index and the heart rate was weak. CONCLUSIONS: After a painful procedure, such as a blood draw, the NIPE monitor showed a significant decrease in the first 4 min, which was more pronounced in preterm infants, in repeated procedures or after caesarean delivery. The NIPE index could help identify infants experiencing acute procedural pain, complementing clinical rating scales.

Effectiveness of lidocaine spray on radial arterial puncture pain: A randomized double-blind placebo controlled trial.

OBJECTIVE: Radial arterial puncture is a painful procedure. The aim of this study was to evaluate the effect of lidocaine spray (10%) on pain associated with radial artery blood withdrawal for arterial blood gas analysis. METHODS: This randomized, controlled, double-blind study was performed between December 2018 and September 2019. Before radial arterial puncture, 10% lidocaine or placebo spray was applied to each patient by the attending physician, who was blinded with regard to random assignment. The spray was administered six times on the site from a distance of 5 cm. After waiting for 5 min, a radial arterial puncture was performed routinely. The pain levels of patients during radial arterial puncture and 5 min after puncture were evaluated with the visual analog scale (VAS). The Wilcoxon test was used to compare pain scores during puncture. RESULTS: The research was performed with 67 patients (34 patients in the lidocaine group, 33 patients in the placebo group) who were admitted to the emergency department and required ABG analysis. Forty-three patients were men, and 24 were women. The ages of the patients ranged between 19 and 86 years, and the mean (± standard deviation) age was 56.3 ± 16.6 years. Pain levels, as measured by VAS, were significantly lower in the lidocaine group (24.00 mm IQR:[14.75-33.75]) compared with the placebo group (33.00 mm IQR:[22.00-61.50]) during radial arterial puncture (p = 0.011). CONCLUSIONS: The level of pain perceived during radial arterial puncture was significantly lower in those who were administered lidocaine spray. Lidocaine spray application can be used in pain management related to radial arterial puncture.

A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy.

PURPOSE/OBJECTIVE: The primary objective is to examine patient self-assessment of breast pain and cosmesis between three-dimensional (3D-CRT) versus intensity-modulated radiotherapy (IMRT). The secondary objective is to evaluate any relationship of treatment planning conformality of both cohorts to patient-assessed pain. Assessments were performed at interim 12, 24, 36, and 48 months with a final 5-year assessment. MATERIALS/METHODS: In total, 656 patients (3D-CRT n = 328; IMRT n = 328) were randomly assigned to either IMRT or 3D-CRT accelerated partial breast radiotherapy to 38.5 Gy in 10 BID 3.85 Gy fractions. RESULTS: Median follow-up was 3 years. Multivariate analysis showed that pain severity significantly decreased from baseline to the 12-month follow-up visit (<0.001 for both 3D-CRT and IMRT) in each cohort. There was significantly less pain at 2 (p = 0.002) and 3 years (0.045) in the IMRT arm versus the 3D-CRT arm when compared to the baseline pain level. There was no difference in patient-assessed cosmesis at any follow-up point; however, although MD-assessed cosmesis showed no difference from years 1 to 4, there was significantly better cosmesis for 3D-CRT versus IMRT (p = 0.047) at 5 years. There was a significant correlation between a maximum pain score and an increase in the CI100 (indicating less conformity) in the IMRT cohort (p < 0.01) and in the IMRT subgroup when the CI100 was ≤0.37 cohort arm (p = 0.01). CONCLUSION: In the analysis of our primary objective we found that at 2 years, IMRT resulted in more interval improvement in breast pain after baseline when compared to patients treated with 3D-CRT planning. As seen in our secondary analysis, this may be due to the ability of IMRT to achieve higher conformality (as evidenced by lower CI values) resulting in less fibrosis. There were no differences in patient-assessed cosmesis or MD-assessed cosmesis for years 1-4; however, physician-assessed 5-year cosmesis was better with 3D-CRT.

Assessing procedural pain in infants: a feasibility study evaluating a point-of-care mobile solution based on automated facial analysis.

BACKGROUND: The management of procedural pain in infants is suboptimal, in part, compounded by the scarcity of a simple, accurate, and reliable method of assessing such pain. In this study, we aimed to evaluate the psychometric properties of the PainChek Infant, a point-of-care mobile application that uses automated facial evaluation and analysis in the assessment of procedural pain in infants. METHODS: Video recordings of 40 infants were randomly chosen from a purposely assembled digital library of 410 children undergoing immunisation as part of their standard care in Prishtina, Kosovo, between April 4, 2017, and July 11, 2018. For each infant recording, four 10 s video segments were extracted, corresponding to baseline, vaccine preparation, during vaccination, and recovery. Four trained assessors did pain assessments on the video segments of 30 infants, using PainChek Infant standard, PainChek Infant adaptive, the Neonatal Facial Coding System-Revised (NFCS-R) single, the NFCS-R multiple, and the Observer administered Visual Analogue Scale (ObsVAS), on two separate occasions. PainChek Infant's performance was compared to NFCS-R and ObsVAS using correlation in changes in pain scores, intra-rater and inter-rater reliability, and internal consistency. FINDINGS: 4303 pain assessments were completed in two separate testing sessions, on Aug 31, and Oct 19, 2020. The study involved videos of 40 infants aged 2·2-6·9 months (median age 3·4 months [IQR 2·3-4·5]). All pain assessment tools showed significant changes in the recorded pain scores across the four video segments (p≤0·0006). All tools were found to be responsive to procedure-induced pain, with the degree of change in pain scores not influenced by pre-vaccination pain levels. PainChek Infant pain scores showed good correlation with NFCS-R and ObsVAS scores (r=0·82-0·88; p<0·0001). PainChek Infant also showed good to excellent inter-rater reliability (ICC=0·81-0·97, p<0·001) and high levels of internal consistency (α=0·82-0·97). INTERPRETATION: PainChek Infant's use of automated facial expression analysis could offer a valid and reliable means of assessing and monitoring procedural pain in infants. Its clinical utility in clinical practice requires further research. FUNDING: PainChek.

A Randomized Controlled Trial of Virtual Reality in Awake Minor Pediatric Plastic Surgery Procedures.

BACKGROUND: Virtual reality has been used to alleviate pain and anxiety in a variety of medical procedures. The authors sought to explore the effects of virtual reality in common awake minor plastic surgery procedures where children may experience discomfort. METHODS: A randomized controlled trial compared virtual reality to standard-of-care distraction among children aged 6 to 16 years undergoing awake minor plastic surgery procedures at a quaternary children's hospital. Primary outcome was change in Faces Pain Scale-Revised pain score, and secondary outcomes included change in Venham Situational Anxiety Scale score, procedure duration, administration of local anesthetic, and pain/anxiety management satisfaction. RESULTS: Mean pain and anxiety scores were similar in both groups (p = 0.60 and p = 0.18, respectively), and procedure duration was shorter with virtual reality (22 minutes versus 29 minutes; p = 0.002). Duration remained shorter in a linear regression model accounting for procedure type (p = 0.01). Similar proportions of children received additional local anesthetic after the initial dose (virtual reality, n = 6; standard of care, n = 9; p = 0.19) and median pain management satisfaction was similar (virtual reality, 9 of 10; standard of care, 9 of 10; p = 0.41). Median anxiety management satisfaction was similar (virtual reality, 9 of 10; standard of care, 9 of 10; p = 0.05). Younger children reported more "fun" than older children with virtual reality (p = 0.02). Surgeons reported interest "using virtual reality again" in 83 percent of cases. CONCLUSIONS: The use of virtual reality for awake pediatric plastic surgery reduced procedure time but not pain or anxiety compared to standard of care in children aged 6 to 16 years. Virtual reality was safe and well-liked and should be considered as an additional tool. Increased efficiency may allow more cases to be performed. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Ultrasound-guided transrectal implantation of fiducial markers for image-guided radiotherapy of prostate cancer without local anesthesia: Patient-reported gastrointestinal-genitourinary system complications and pain.

PURPOSE: The present study evaluates procedure-associated pain and side effects in the gastrointestinal-genitourinary system in patients with early-stage prostate cancer who were treated with image-guided radiotherapy (IGRT), accompanied by an ultrasound-guided transrectal implantation of fiducial markers, without local anesthesia. MATERIALS AND METHODS: A total of 46 patients who referred to our clinics between 2012 and 2017 with a diagnosis of early-stage prostate cancer were included in the study. Before undergoing radiotherapy, all patients were implanted with three intraprostatic fiducial markers through the ultrasound-guided transrectal approach without local anesthesia. The patients underwent radiotherapy after the clinical target volumes were established, in accordance with the respective risk groups, and localization of the markers was confirmed before each therapy session. The levels of procedure-associated pain and side effects were graded immediately after the procedure through the use of a patient-based scoring system. RESULTS: The faces pain scale - revised version was used for the measurement of the severity of procedure-associated pain. Of the total study sample, the facial expressions of 38 patients (35%) corresponded to level 0 in the study, seven (15%) to level 2, and a single patient (2%) to level 4. None of the facial expressions of the patients corresponded to levels 6, 8, or 10. The evaluation of procedure-related genitourinary and gastrointestinal system side effects indicated that nine patients (20%) experienced side effects, while no side effects were reported in 37 patients (80%). The reported side effects included rectal bleeding in two patients (4%), dysuria in three patients (6%), hematuria in five patients (11%), and frequent urination in five patients (11%). None of the patients experienced fever or hematospermia. All side effects were reported by the respondents as "a little," while only one patient answered positively to the question on the frequency of urination. Among the patients who answered "yes" and "a little" to the questions evaluating genitourinary and gastrointestinal system side effects, the severity of these events was reported as Grade 1, corresponding to mild adverse, in only 9 (20%) patients. None of the patients experienced a Grade 2 or higher severe adverse event. In the comparison of the severity of pain of the patients during the fiducial marker procedure without local anesthesia with the severity of pain during the biopsy, 24 patients (80%) reported "lower" levels of pain, while five patients (20%) reported "equal" levels of pain. None of the patients stated that they had experienced "more" pain. CONCLUSION: IGRT accompanied by an ultrasound-guided implantation of fiducial markers without local anesthesia can be considered a safe method, given the associated acceptable levels of pain, low side effect profiles, and high prostate-specific antigen control rates.

Rectal wall sparing effect of a rectal retractor in prostate intensity-modulated radiotherapy.

PURPOSE: The objective of the study was to evaluate the effectiveness of a rectal retractor (RR) designed to protect rectal tissue in intensity-modulated radiotherapy (IMRT) by pushing rectal wall (RW) away from the prostate. MATERIALS AND METHODS: Twelve patients with localized prostate cancer were enrolled into this study. Patients underwent two computed tomography (CT) scans without and with RR. A prescription of 80 Gy in 40 fractions was planned on CT scans with and without RR. This study evaluates the ability of the RR in RW dose reduction, in particular reduction of the RW V70Gy≥ 25% in comparison with the plan without RR dose-volume histograms were generated with and without RR. The patient's tolerance was assessed by patient-reported outcomes. RESULTS: The planning target volume coverage was equal for both without and with RR (P = 0.155). The mean dose to the RW was statistically significantly lower for the plan with RR than that for the plan without RR, a mean reduction of 5.8 Gy (P = 0.003). Significant relative reductions in rectal dose-volume parameters whether in absolute volume (cc) or as a percentage of contoured RW were detected. A relative reduction more than 25% in RW V70Gy(%) in 100% of patients was achieved. The rectal retraction resulted in a significant increase in the prostate to the rectum space at the prostate midgland level, an absolute increase of 2.7 mm. The retraction of the rectum induced a mean (±standard deviation) pain score of 2.7 (±1.3) according to the visual analog score. CONCLUSION: The application of a RR showed a remarkable rectal sparing effect during prostate IMRT. This may lead to reduced acute and late rectal toxicities in prostate IMRT.

Randomized, Placebo-Controlled Phase 1/2 Study to Determine the Appropriate ATX-101 Concentration for Reduction of Submental Fat.

BACKGROUND: ATX-101 is indicated for submental fat treatment. OBJECTIVE: Evaluate ATX-101 versus placebo for reducing submental fat. MATERIALS AND METHODS: Adults with unwanted submental fat across 6 global sites were randomized to ATX-101 (0.5%, 1.0%, or 2.0%) or placebo for ≤4 treatments every 28 days. Outcomes included safety (adverse events and pain visual analog scale) throughout the study and efficacy (submental fat rating, patient satisfaction, and submental fat improvements) at Week 16. RESULTS: Eighty-four of 85 enrolled patients received ≥1 ATX-101 treatment (0.5% [n = 20], 1.0% [n = 20], 2.0% [n = 22] or placebo [n = 22]). Most patients (n = 82) experienced adverse events, which were mostly mild/moderate, seemed to be dose-related, and led to no study discontinuations. The mean pain scores were highest in the ATX-101 1.0% and 2.0% groups. Week-16 change from baseline in the submental fat rating scale was significantly greater for ATX-101 0.5% and 1.0% versus placebo (p ≤ .05). At Week 16, 71%, 74%, 53%, and 40% of patients in the ATX-101 0.5%, 1.0%, 2.0%, and placebo groups, respectively, achieved a ≥1-grade reduction in submental fat from baseline. Satisfaction with appearance and patient-assessed global improvement ratings increased in all ATX-101 treatment groups versus placebo. CONCLUSION: All ATX-101 concentrations were safe and efficacious for moderate/severe submental fat reduction.

Quantifying procedural pain associated with office gynecologic tract sampling methods.

OBJECTIVE: Emerging technologies may enable detection of endometrial cancer with methods that are less invasive than standard biopsy methods. This study compares patient pain scores among 3 office gynecologic tract sampling methods and explores their potential determinants. METHODS: A prospective study including 3 sampling methods (tampon, Tao brush (TB), endometrial biopsy (EB)) was conducted between December 2015 and August 2017 and included women ≥45 years of age presenting with abnormal uterine bleeding, postmenopausal bleeding, or thickened endometrial stripe. Patients rated pain after each sampling procedure using a 100-point visual analog scale (VAS). RESULTS: Of 428 enrolled, 190 (44.39%) patients underwent all 3 sampling methods and reported a VAS score for each. Nearly half were postmenopausal (n = 93, 48.9%); the majority were parous (172, 90.5%) of which 87.8% had at least one vaginal delivery. Among the 190 patients, the median (IQR) pain score was significantly lower for sampling via tampon (0 [0,2]) compared to TB (28 [12, 52]) or EB (32 [15, 60]) (both p < 0.001, Wilcoxon signed rank test). Among women who underwent tampon sampling, age and pain scores showed a weak positive correlation (Spearman rank correlation, r = 0.14; p = 0.006); EB sampling was associated with a weak inverse correlation between parity and pain scores (r = -0.14; p = 0.016). CONCLUSION: Gynecologic tract sampling using a tampon had significantly lower pain than both EB and TB. Pain with tampon sampling was positively correlated with age and pain with EB sampling was inversely correlated with parity. Pain scores for TB and EB were not significantly related to age, menopausal status, or BMI.

A Nationwide Analysis of Cleft Palate Repair: Impact of Local Anesthesia on Operative Outcomes and Hospital Cost.

BACKGROUND: This study investigates the associations between local anesthesia practice and perioperative complication, length of stay, and hospital cost for palatoplasty in the United States. METHODS: Patients undergoing cleft palate repair between 2004 and 2015 were abstracted from the Pediatric Health Information System database. Perioperative complication, length of stay, and hospital cost were compared by local anesthesia status. Multiple logistic regressions controlled for patient demographics, comorbidities, and hospital characteristics. RESULTS: Of 17,888 patients from 49 institutions who met selection criteria, 8631 (48 percent), 4447 (25 percent), and 2149 (12 percent) received epinephrine-containing lidocaine, epinephrine-containing bupivacaine, and bupivacaine or ropivacaine alone, respectively. The use of epinephrine-containing bupivacaine or bupivacaine or ropivacaine alone was associated with decreased perioperative complication [adjusted OR, 0.75 (95 percent CI, 0.61 to 0.91) and 0.63 (95 percent CI, 0.47 to 0.83); p = 0.004 and p = 0.001, respectively]. Only bupivacaine- or ropivacaine-alone recipients experienced a significantly reduced risk of prolonged length of stay on adjusted analysis [adjusted OR, 0.71 (95 percent CI, 0.55 to 0.90); p = 0.005]. Risk of increased cost was reduced in users of any local anesthetic (p < 0.001 for all). CONCLUSIONS: Epinephrine-containing bupivacaine or bupivacaine or ropivacaine alone was associated with reduced perioperative complication following palatoplasty, while only the latter predicted a decreased postoperative length of stay. Uses of epinephrine-containing lidocaine, epinephrine-containing bupivacaine, and bupivacaine or ropivacaine alone were all associated with decreased hospital costs. Future prospective studies are warranted to further delineate the role of local anesthesia in palatal surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Anesthetic management for cesarean delivery in a woman with congenital atlantoaxial dislocation and Chiari type I anomaly: a case report and literature review.

BACKGROUND: The preferable choice of anesthesia for the patients with congenital atlantoaxial dislocation (CAAD) and type I Arnold Chiari malformations (ACM-I) has been a very confusing issue in clinical practice. We describe the successful administration of combined spinal-epidural anesthesia for a woman with CAAD and ACM-1 accompanied by syringomyelia. CASE PRESENTATION: Our case report presents the successful management of a challenging obstetric patient with CAAD and ACM-1 accompanied by syringomyelia. She had high risks of difficult airway and aspiration. The injection of bolus drugs through the spinal or epidural needle may worsen the previous neurological complications. The patient was well evaluated with a multidisciplinary technique before surgery and the anesthesia was provided by a skilled anesthesiologist with slow spinal injection. CONCLUSIONS: An interdisciplinary team approach is needed to weigh risks and benefits for patients with CAAD and ACM-1 undergoing cesarean delivery. Therefore, an individual anesthetic plan should be made basing on the available anesthetic equipments and physicians' clinical experience on anesthetic techniques.

Comparison Between Cyanoacrylate Embolization and Radiofrequency Ablation for Superficial Venous Incompetence: A Systematic Review and Meta-analysis.

BACKGROUND: Chronic venous disease is a debilitating condition involving great saphenous vein (GSV) incompetence. OBJECTIVE: To investigate the efficacy and effectiveness of cyanoacrylate embolization (CAE) versus radiofrequency ablation (RFA) in patients with incompetent GSVs. MATERIALS AND METHODS: PubMed, Embase, and the Cochrane library were searched. The primary outcomes were the Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), closure rate, and visual analog scale (VAS) for pain. RESULTS: This meta-analysis included 378 and 590 patients who underwent CAE and RFA, respectively. Cyanoacrylate embolization was comparable with RFA in VCSS (weighted mean difference [WMD] = -0.03, 95% confidence interval [CI]: -0.18 to 0.12, p = .686), AVVQ (WMD = -0.08, 95% CI: -0.38 to 0.21, p = .570), closure rate (odds ratio [OR] = 0.61, 95% CI: 0.18-2.01, p = .414), and VAS (standardized mean difference [SMD] = 0.24, 95% CI: -0.59 to 1.06, p = .523). There were no significant differences between CAE and RFA regarding the occurrence of phlebitis (OR = 1.22, 95% CI: 0.70-2.13, p = .479) and pigmentation (OR = 0.48, 95% CI: 0.18-1.31, p = .153), but CAE had a lower risk of ecchymosis (OR = 0.45, 95% CI: 0.25-0.81, p = .007) and paresthesia (OR = 0.16, 95% CI: 0.03-0.99, p = .049). CONCLUSION: Cyanoacrylate embolization and RFA demonstrated no significant differences in VCSS, AVVQ, closure rate, and pain score for patients with incompetent GSVs. Patients in the CAE group had a lower risk of ecchymosis and paresthesia compared with the RFA group.