Double-blind Randomized Clinical Trial Research Articles

Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery

Epidural anesthesia is a primary choice for cesarean delivery, but supplemental analgesics are often required to relieve pain during uterine traction. To investigate the sedative and analgesic effects of intravenous esketamine administered before childbirth via cesarean delivery with the patient under epidural anesthesia. This multicenter, double-blind randomized clinical trial assessed 903 women 18 years or older who had full-term single pregnancy and were scheduled for elective cesarean delivery with epidural anesthesia in 5 medical centers in China from September 18, 2021, to September 20, 2022. Patients were randomized to receive intravenous injection of 0.25 mg/kg of esketamine or placebo before incision. The coprimary outcomes included scores on the numeric rating scale of pain (an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain; a difference of ≥1.65 points was clinically meaningful) and Ramsay Sedation Scale (a 6-point scale, with 1 indicating restlessness and 6 indicating deep sleep without response; a difference of ≥2 points was clinically meaningful) immediately after fetal delivery. Secondary outcomes included neonatal Apgar score assessed at 1 and 5 minutes after birth. A total of 600 women (mean [SD] age, 30.7 [4.3] years) were enrolled and randomized; all were included in the intention-to-treat analysis. Immediately after fetal delivery, the score on the numeric rating scale of pain was lower with esketamine (median [IQR], 0 [0-1]) than with placebo (median [IQR], 0 [0-2]; median difference, 0; 95% CI, 0-0; P = .001), but the difference was not clinically important. The Ramsay Sedation Scale scores were higher (sedation deeper) with esketamine (median [IQR], 4 [3-4]) than with placebo (median [IQR], 2 [2-2]; median difference, 2; 95% CI, 2-2; P < .001). The neonatal Apgar scores did not differ between the 2 groups at 1 minute (median difference, 0; 95% CI, 0-0; P = .98) and at 5 minutes (median difference, 0; 95% CI, 0-0; P = .27). Transient neurologic or mental symptoms were more common in patients given esketamine (97.7% [293 of 300]) than in those given placebo (4.7% [14 of 300]; P < .001). For women undergoing cesarean delivery under epidural anesthesia, a subanesthetic dose of esketamine administered before incision produced transient analgesia and sedation but did not induce significant neonatal depression. Mental symptoms and nystagmus were common but transient. Indications and the optimal dose of esketamine in this patient population need further clarification, but study should be limited to those who require supplemental analgesia. ClinicalTrials.gov Identifier: NCT04548973.

Comparison of dexmedetomidine and ketamine in adjuvant with morphine for postoperative pain management following lumbar fusion surgery

BackgroundPostoperative pain leads to increased opioid consumption and associated adverse effects. Adjuvant analgesia can improve pain management and reduce opioid consumption. This study aimed to compare the analgesic effects of adjuvants of dexmedetomidine and ketamine with morphine in patients with lumbar fusion. Patients and methodsIn this double-blind randomized clinical trial, patients undergoing elective lumbar fusion surgery were included. These patients were randomly divided into three groups. Group D received 50 μg dexmedetomidine and 20 mg of intravenous morphine, group K received 50 mg of ketamine and 20 mg of intravenous morphine, and control group C received 20 mg of intravenous morphine with normal saline (100 cc) in the form of PCA (patient-controlled analgesia) pump. The severity of pain after surgery was assessed using a visual analog scale (VAS) 2, 6, and 24 postoperative hours. Nausea and vomiting after the surgery, the amount of drug consumption from the PCA pump, and the duration of hospital stay were also evaluated. ResultsOf 196 patients included in the study, 69.4 % were males and 30.6 % were females. At 2,6 and 24 postoperative hours, the pain was significantly less in group D, compared to groups K and C, p < 0.05. However, in all three groups, pain was significantly reduced at all time intervals, p < 0.05. Group C had significantly the greatest incidence of postoperative nausea and vomiting, ileus, and prolonged hospitalization, p < 0.05. ConclusionsThe results of this study showed that postoperative pain management with the adjuvant of dexmedetomidine and morphine is most effective in terms of pain, adverse effects, hospitalization, and patient satisfaction. It is also superior to ketamine and morphine adjuvant and morphine alone, respectively.

The anti-dyslipidemia property of saffron petal hydroalcoholicextract in cardiovascular patients: A double-blinded randomized clinical trial

Dyslipidemia is one of the most important risk factors of cardiovascular diseases (CVDs). Despite developments in pharmacological treatments for dyslipidemia there are several challenges. Recently some herbs highly considered to control dyslipidemia due to their low toxicity and high potency. In this study we investigated the effects of saffron petals on the lipid profile of dyslipidemia patients as well as several other biochemical blood factors. In this double blind, placebo controlled, clinical trial, we used systematic random sampling to divide 40 patients with at least two abnormalities in the following factors: (high-density lipoproteins (HDL) ≤40, low-density lipoproteins (LDL) ≥130, triglycerides (TG) ≥200, total cholesterol (Cho) ≥200), into 2 groups of 21 ones. At the end of the intervention period, serum lipid factors, alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), urea, creatinin (CR) and fasting blood sugar (FBS) were measured and statistically compared with their values just before the intervention. We found that the saffron petal pills markedly (P<0.001) decreased the serum lipid levels of patients (TG, Cho and LDL) in the intervention group (113.81±12.93, 56.52±4.68 and 48.28±3.70) as compared to the placebo group (18.42±15.79, 4.57±4.40 and 7.38±3.54). Also, comparing the mean value of differences in two groups before and after the intervention showed significant reduction in TG (113.81±26), Cho (56.53±0.30) and LDL (48.28±4.30) levels (P<0.001). The saffron petal pills considerably reduced blood serum lipid profile and as well as urea and CR of dyslipidemia patients. So, this plant may be used as a potent phytomedicine for treatment and prevention of dyslipidemia and cardiovascular disorders. However, the results indicated that no statistical change was observed in the level of other biochemical blood factors such as ALT, AST, ALP and FBS.

Comparison of the Effects of Nano Micelles Curcumin and Ibuprofen on Pain Reduction After Initial Arch Wire Placement: A Double-Blind Randomized Clinical Trial Study

Aim: To compare the effect of nano micelles curcumin and ibuprofen on pain reduction after primary arch wire placement in orthodontic patients. Materials and Methods: In this double-blind randomized clinical trial study, 60 female patients between the ages of 14 and 30 years who had moderate tooth crowding and were candidates for fixed orthodontic treatment were examined. The subjects were divided into four groups ( n = 15) of nano micelles curcumin (SinaCurcumin), ibuprofen, placebo of SinaCurcumin, and placebo of ibuprofen. Each patient received a questionnaire and a rectangular, flexible cube of silicone to record the severity of their pain under each of the three situations (biting posterior teeth together, fitting anterior teeth together, and without fitting the teeth together) at the designated time points (2 h, 6 h, bedtime, the second, third, and seventh days after archwire placement). The obtained outcomes were statistically verified and analyzed by the employment of SPSS Statistics Version 22. Results: despite the lack of any significant differences among the four groups in terms of pain severity upon biting by the anterior teeth 2 h after the intervention, there was a considerable difference in the cases of 6 h, bedtime, and the second, third, and seventh days subsequent of the placement of archwire. Our data indicated a lower rate of pain severity for SinaCurcumin group than the placebo of SinaCurcumin and ibuprofen groups at 6 h after the archwire placement. However, the pain severity of SinaCurcumin group at bedtime was significantly lower than ibuprofen group, which also resulted in a notably lower rate than the other groups at the second, third, and seventh days after the placement of archwire. Conclusion: These findings support the effectiveness of curcumin in reducing the pain severity of orthodontic patients. Nevertheless, it is a necessity to conduct further confirmation trials on this latter.

Efficacy and Safety of Avalglucosidase Alfa in Patients With Late-Onset Pompe Disease After 97 Weeks

In the previously reported Comparative Enzyme Replacement Trial With neoGAA Versus rhGAA (COMET) trial, avalglucosidase alfa treatment for 49 weeks showed clinically meaningful improvements in upright forced vital capacity (FVC) percent predicted and 6-minute walk test (6MWT) compared with alglucosidase alfa. To report avalglucosidase alfa treatment outcomes during the COMET trial extension. This phase 3 double-blind randomized clinical trial with crossover in the extension period enrolled patients 3 years and older with previously untreated late-onset Pompe disease (LOPD) between November 2, 2016, and February 10, 2021, with primary analysis after 49 weeks. Patients were treated at 55 referral centers in 20 countries. Efficacy outcomes were assessed at 97 weeks and safety outcomes to last follow-up, with data cutoff at February 10, 2021. Data were analyzed from May to June 2021. Random assignment (1:1) to receive 20 mg/kg of avalglucosidase alfa or alglucosidase alfa by intravenous infusion every other week for 49 weeks; thereafter, all patients received 20 mg/kg of avalglucosidase alfa every other week. The primary outcome was the least squares (LS) mean change from baseline in FVC percent predicted. Secondary outcomes included the LS mean change from baseline in 6MWT, muscle strength, motor function, quality of life, and disease biomarkers. Safety and tolerability were also assessed. Of 100 participants from the double-blind treatment period, 95 entered the extension period. Of these, 51 (54%) were men, and the mean (range) age was 48.3 (10-79) years. At the start of this study, mean upright FVC percent predicted was similar between treatment arms, and 6MWT distance was greater in the avalglucosidase alfa arm. From baseline to week 97, LS mean (SE) FVC percent predicted increased by 2.65 (1.05) for those who continued avalglucosidase alfa and 0.36 (1.12) for those who switched to avalglucosidase alfa. The LS mean (SE) 6MWT distance increased by 18.60 (12.01) m and 4.56 (12.44) m, respectively. For participants who switched to avalglucosidase alfa, FVC percent predicted remained stable (LS mean [SE] change from week 49 to 97, 0.09 [0.88]) and 6MWT distance improved (LS mean [SE] change from week 49 to 97, 5.33 [10.81] m). Potentially treatment-related adverse events were reported in 29 patients (56.9%) who continued avalglucosidase alfa and in 25 patients (56.8%) who switched. In this randomized clinical trial extension, maintenance of positive clinical outcomes was demonstrated for patients continuing avalglucosidase alfa treatment and, to a lesser extent, patients who switched from alglucosidase alfa. No new safety concerns were observed. ClinicalTrials.gov Identifier: NCT02782741.

Low-load exercise program and platelet-rich plasma for intrasubstance tear in lateral elbow tendinopathy: protocol for a double-blinded randomized clinical trial

Background: Lateral elbow tendinopathy (LET) is one of the most common musculoskeletal conditions. Treatment includes a series of therapeutic alternatives. However, the resolution takes nearly 24 months. Platelet-rich plasma (PRP) is an effective option, especially when the tendon presents an intrasubstance tear (IST). It is unknown what type of rehabilitation plan is more effective after this treatment. Aim: To perform a study protocol of a double-blinded, randomized clinical trial to determine the efficacy of a specific low-load exercise program in patients with LET and IST treatment with PRP under US-guided Methods: A single-center, parallel-controlled, randomized, double-blinded, phase III trial was pro-posed. Patients over 18 years-old diagnosed with LET and IST treated with US-guided PRP will be selected. Two arms of treatment will be allocated with a ratio a 1:1 ratio (low-load exercise protocol vs. conventional exercise program). The principal outcome will be the reduction of the tendon tear size. Secondary outcomes will include Patient-Rated Tennis Elbow Evaluation score, visual analogue scale, and handgrip at baseline, 3, 6, and 12 months of follow-up. Statistical tests will be 2-sided t-test with an alpha level (significance level) of 0.05. Discussion: The intervention aims to significantly reduce tendon tear size and improve pain and functionality in patients with LET and IST treated with US-guided PRP. We proposed one of the first studies in the literature that considered a detailed standardized exercise protocol applied to these patients. The result could be used to speed up treatment save time and money, help evaluate guidelines, and improve patients' and athletes' quality of life.

Comparison of Dextrose Prolotherapy and Triamcinolone Intraarticular Injection on Pain and Function in Patients with Knee Osteoarthritis - A Randomized Clinical Trial.

The present study was performed to assess the therapeutic effects of combined intra and extraarticular dextrose prolotherapy on knee osteoarthritis and its comparison with intra- articular triamcinolone injection. In this study, 50 patients suffering from knee osteoarthritis were allocated into two groups as a double-blind randomized clinical trial. The first group received one session of dextrose prolotherapy as one intra-articular injection of 10cc dextrose 16% and periarticular intradermal injections of dextrose 12% at 4 points around the knee (2.5 cc at each point). The second group underwent therapy with one intra-articular injection of triamcinolone (40 mg). Compared to pretreatment, both interventions caused significant improvement in pain (evaluated by VAS) and WOMAC (all its components) in 1 and 3 months postintervention (all with P-value < 0.005). In the first month, pain reduction was significantly better in corticosteroid group (P-Value 0.002 and 0.048 respectively). In third month post intervention, improvements in VAS and WOMAC components were significantly greater in prolotherapy group. Both methods of corticosteroid and dextrose prolotherapy (combined intra and extraarticular technique) are effective on pain and function of patients with knee osteoarthritis. Compared to corticosteroid, prolotherapy method was associated with less pain reduction in short- term, but its effects were more persistent and in midterm examinations (3 months), it was more effective than corticosteroid.

Prevention of Dry Socket with Ozone Oil-Based Gel after Inferior Third Molar Extraction: A Double-Blind Split-Mouth Randomized Placebo-Controlled Clinical Trial

Tooth extraction is followed by a sequence of elaborate local changes affecting hard and soft tissues. Dry socket (DS) can occur as intense pain around and in the extraction site, with an incidence from 1-4% after generic tooth extraction to 45% for mandibular third molars. Ozone therapy has gained attention in the medical field because of its success in the treatment of various diseases, its biocompatible properties and its fewer side effects or discomfort than drugs. To investigate the preventive effect of the sunflower oil-based ozone gel Ozosan® (Sanipan srl, Clivio (VA), Italy) on DS, a double-blind split-mouth randomized placebo-controlled clinical trial was conducted according to the CONSORT guidelines. Ozosan® or the placebo gel were put in the socket, and the gels were washed off 2 min later. In total, 200 patients were included in our study. The patient population comprised 87 Caucasian males and 113 Caucasian females. The mean age of the included patients was 33.1 ± 12.4 years. Ozosan reduced the incidence of DS after inferior third molar extraction from 21.5% of the control to 2% (p < 0.001). Concerning the dry socket epidemiology, the incidence was not significantly correlated with gender, smoking or mesioangular, vertical or distoangular Winter's classification. Post hoc power calculation showed a power of 99.8% for this data, with alpha = 0.001.

Effect of fluvoxamine on preventing neuropsychiatric symptoms of post COVID syndrome in mild to moderate patients, a randomized placebo-controlled double-blind clinical trial

BackgroundShortly after the Coronavirus disease 2019 (COVID-19) pandemic, a considerable number of recovered patients reported persisting symptoms, especially neuropsychological manifestations, which were later named post-COVID syndrome (PCS). Immune dysregulation was suggested as one of the main mechanisms for PCS. Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) that is mostly used to treat depression, anxiety disorders, and obsessive–compulsive disorder, has been suggested as an anti-COVID drug due to its anti-inflammatory effects, mainly through the sigma-1 receptor. Therefore, we aimed to evaluate fluvoxamine's effect on PCS neuropsychiatric symptoms.MethodIn this double-blind randomized clinical trial, we included confirmed mild to moderate COVID-19 outpatients using polymerase chain reaction (PCR) by an infectious disease specialist. The presence of severe COVID-19 symptoms was evaluated by the infectious disease specialist and included dyspnea, SpO2 < 94% on room air, PaO2/FiO2 < 300 mm Hg, a respiratory rate > 30 breaths/min, and lung infiltrates > 50%. Then we performed permuted block randomization and assigned patients 1:1 into two groups to either receive fluvoxamine 100 mg tablet or a placebo daily for 10 days. Eligible patients were evaluated after 12 weeks for the presence of fatigue, as the primary, and other PCS symptoms as secondary outcomes.ResultsWe screened a total of 486 patients from March to June 2022. After 12 weeks, 42 patients receiving fluvoxamine and 43 patients receiving Placebo were evaluated for PCS. Patients had a mean age of 38.5 ± 14.1 and 48% of them were women. Fatigue was significantly lower in the fluvoxamine group (p-value 0.026). No significant differences were observed in other symptoms.ConclusionWe concluded that taking fluvoxamine during active COVID-19 can reduce the chance of fatigue but the advantage of fluvoxamine was not observed for other symptoms. Further studies are necessary to confirm these preliminary results.

Clonidine premedication was better in preventing hemodynamic response changes post laryngoscopy and endotracheal intubation compared to fentanyl premedication

Background: Airway control under general anesthesia can be performed using laryngoscopy and endotracheal intubation. Laryngoscopy and endotracheal intubation produce mechanical and chemical stimuli that increase sympatho-adrenergic activity, causing an increased hemodynamic response. Various pharmacological and non-pharmacological methods have been used to reduce the response of hemodynamic changes in laryngoscopy and endotracheal intubation, such as fentanyl and clonidine. This study aimed to compare the effectiveness of fentanyl and clonidine in reducing hemodynamic response changes after laryngoscopy and endotracheal intubation. Methods: A double-blind randomized clinical trial was conducted on 48 elective surgery patients in the Surgical Installation of Dr. Kariadi General Hospital and Diponegoro National Hospital Semarang who were planned for laryngoscopy and endotracheal intubation procedures. Subjects were randomized and divided into 2 groups. Group 1 was administered with 2 µg/kgBW intravenous fentanyl premedication and group II was administered with 1 µg/kgBW intravenous clonidine premedication 5 minutes before the laryngoscopy and endotracheal intubation procedure. At baseline and at 1, 3, and 5 minutes after laryngoscopy and endotracheal intubation, the systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) were recorded simultaneously. Results: Both fentanyl and clonidine could maintain SBP, DBP, MAP, and HR within normal range. However, clonidine premedication seemed to be better in preventing hemodynamic response changes post-laryngoscopy and endotracheal intubation compared to fentanyl premedication. Clonidine premedication showed lower SBP, DBP, and MAP, but not HR, at the 1st and 3rd-minute post laryngoscopy and endotracheal intubation in comparison with fentanyl premedication (p&lt;0.05). Conclusion: If confirmed by further findings, clonidine premedication may be preferable to prevent hemodynamic changes after laryngoscopy and endotracheal intubation.

Prevention of relapse in drug sensitive pulmonary tuberculosis patients with and without vitamin D3 supplementation: A double blinded randomized control clinical trial.

The immunomodulatory effects of vitamin D are widely recognized and a few studies have been conducted to determine its utility in the treatment of tuberculosis, with mixed results. This study was conducted to see if vitamin D supplementation in patients with active pulmonary tuberculosis (PTB) in the Indian population contributed to sputum smear and culture conversion as well as the prevention of relapse. This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15-60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were randomly assigned (1:1) to receive standard anti-tubercular treatment (ATT) with either supplemental dose of oral vitamin D3 (60,000 IU/sachet weekly for first two months, fortnightly for next four months followed by monthly for the next 18 months) or placebo with same schedule. The primary outcome was relapse of PTB and secondary outcomes were time to conversion of sputum smear and sputum culture. A total of 846 participants were enrolled between February 1, 2017 to February 27, 2021, and randomly assigned to receive either 60,000 IU vitamin D3 (n = 424) or placebo (n = 422) along with standard ATT. Among the 697 who were cured of PTB, relapse occurred in 14 participants from the vitamin D group and 19 participants from the placebo group (hazard risk ratio 0.68, 95%CI 0.34 to 1.37, log rank p value 0.29). Similarly, no statistically significant difference was seen in time to sputum smear and sputum culture conversion between both groups. Five patients died each in vitamin D and placebo groups, but none of the deaths were attributable to the study intervention. Serum levels of vitamin D were significantly raised in the vitamin D group as compared to the placebo group, with other blood parameters not showing any significant difference between groups. The study reveals that vitamin D supplementation does not seem to have any beneficial effect in the treatment of PTB in terms to the prevention of relapse and time to sputum smear and culture conversion. CTRI/2021/02/030977 (ICMR, Clinical trial registry-India).

Fentanyl-Propofol Versus Ketamine-Propofol Combination for Sedation and Recovery in ERCP: A Double-Blinded Randomized Clinical Trial

Objective: The main goal of this study was to investigate the groups receiving fentanyl-propofol (fentP) against ketamine-propofol (ketP) in ERCP in terms of sedation, rescue sedation requirement, and recovery scores. Additionally, evaluated were the procedure's hemodynamic changes, postoperative pain score, complications, and endoscopist satisfaction. Methodology: A double-blinded randomized clinical trial was undertaken at the Dr. Ruth K.M. Pfau Civil Hospital Karachi's endoscopic room (DUHS) for six months. By using OPEN EPI sample size calculator, sample size was calculated. A total of 124 patients for elective ERCP were randomized into two groups by SNOSE protocol. Groups A and B, fentanyl-propofol (fentP) and ketamine-propofol (ketP), respectively, each contain 62 patients. All patients were given a loading dose of propofol 0.5 mg/kg, followed by a 75 ug/kg/minute infusion. The group fentP received fentanyl 1ml/kg (1 ug/kg) and the group ketP received ketamine 1ml/kg (0.5mg/kg). Ramsay sedation scores, the necessity for rescue sedation, and the Aldrete score post-operatively were noted. Hemodynamics during surgery and complications were also noted. Results: Sedation began noticeably earlier than usual in the group B at 0, 2 and 4 minutes (p-value &lt;0.05), whereas sedation scores were higher in the group A at 8,10, and 15 minutes (p-value &lt;0.05). Early sedation in the group B led to less consumption of rescue sedation doses (p-value &lt;0.01). However, recovery scores were comparable in each groups (p-value &gt;0.05). Conclusion: We were able to conclude that during ERCP, ketP had a significantly faster sedative onset than fentP, with less complication and a quicker recovery. Keywords: Propofol, KetP, FentP, ketamine, fentanyl, Sedation, Analgesia, ERCP, Monitored Anesthesia care.

Comparative Evaluation of White Spot Lesion incidence between NovaMin, Probiotic, And Fluoride containing Dentifrices during Orthodontic treatment Using Laser Fluorescence - A Prospective Randomized Controlled Clinical Trial

ABSTRACT Background Orthodontic appliances act as plaque traps leading to the demineralization of teeth. Aim The purpose of the study was to compare Probiotics, NovaMin, and fluoride-containing dentifrices in terms of the incidence of white spot lesions in subjects undergoing treatment with fixed appliances using laser fluorescence. Materials and Methods In this prospective double-blinded randomized clinical trial, a total of 93 subjects were equally assigned to one of the three groups (Group A – Probiotic containing dentifrice, Group B – NovaMin containing dentifrice and group C – Fluoride containing dentifrice). Diagnodent scores were noted at T0 (just before bonding) and T1 (6 months into treatment). Statistical analyses were performed with Windows version 20.0 of IBM SPSS Statistics. Results Significant intergroup differences were noted in all teeth except for the lower right central incisor . Teeth with the highest incidence of WSLs were the lower right canine in group C (12.9%), and the least incidence of WSL was noted in the lower left lateral incisor (group B-0.92%). An overall higher incidence of WSLs was noted in group C (46.37%) as compared to group A (20.37%) and group B (43.05%). Males had a higher incidence of WSLs in all the three groups. The incidence of WSLs was highest in the age group of 26–35 years in all three groups. Conclusion WSL incidence was least in subjects on Probiotics-containing dentifrice. Adult males had a high incidence of WSLs. The lower right canine had the highest overall incidence of WSLs in all groups.

Indirect Spinal Canal Decompression Using Ligamentotaxis Compared With Direct Posterior Canal Decompression in Thoracolumbar Burst Fractures: A Prospective Randomized Study.

There is still no standard of care to manage thoracolumbar burst fractures. With all the recent advances, posterior approaches are still one of the mainstays of treatment. On the other hand, while spinal canal decompression in neurological impaired patients is an important goal of treatment, its technique remains controversial.This study compared the effects of direct laminectomy decompression against ligamentotaxis/indirect canal decompression on neurological and radiographic improvements. A prospective double-blind randomized clinical trial was conducted on 60 thoracolumbar burst-fracture patients meeting our inclusion and exclusion criteria. They were randomized into 2 treatment arms: (1) direct decompression using laminectomy and (2) indirect decompression using ligamentotaxis/distraction. Each patient was observed for 6 months, and their neurological and radiographical data were collected prospectively. Statistical analysis was done by the Student t test, Friedman test, Mann Whitney-U test, Wilcoxon ranked test, and 1-way analysis of variance. Among 60 patients enrolled in our study, each treatment arm had an improvement in Frankel scores but there was no difference between the groups at any given time. After 6 months of surgery, local sagittal kyphosis improved in both groups (from 32.2 to 7.43 and 29.93 to 8.77 for the indirect and direct groups, respectively), as well as anterior vertebral height ratio (from 57.73 to 70.7 and 62.17 to 66.27 for the indirect and direct group, respectively) and posterior vertebral height ratio (from 61.17 to 74.87 and 64 to 67.5 for the indirect and direct group, respectively). For between-group comparisons after 6 months, there was a significant difference only for posterior vertebral height ratio (P = 0.040). Posterior approaches with ligamentotaxis have shown to be safe and may present the same outcome as direct decompression techniques using wide laminectomy.

The effect of sage (Salvizan gel) compared to triamcinolone acetonide on the treatment of recurrent aphthous stomatitis: a double-blinded randomized clinical trial

BackgroundRecurrent Aphthous Stomatitis (RAS) is one of the most common lesions of the oral mucosa. Herbal medicine can be used for the treatment of this disease. The present study aimed to compare the effects of topical application of Sage (Salvizan) and triamcinolone acetonide gels on RAS.MethodsThis double-blind clinical study recruited sixty patients with minor aphthous ulcers. Half of the patients were treated with Salvizan gel, and the other half were treated with oral triamcinolone acetonide gel. The effect of Salvizan topical gel was evaluated and compared with that of oral triamcinolone acetonide gel. Factors such as Pain recovery time, wound healing time, and pain level was evaluated. Data were analyzed by SPSS version 22 using independent t-test, paired t-test, repeated measures ANOVA, and survival analysis, including Kaplan-Meier and Cox regression.ResultsThe mean duration of pain recovery was 1.5 days for Salvizan and 2.5 days for triamcinolone acetonide (p < 0.001). Moreover, the duration of wound healing was 3.3 days for Salvizan and 6 days for triamcinolone acetonide (p < 0.001). Patients’ satisfaction from factors such as taste and smell had no significant difference between the two groups.ConclusionThe results of this study showed that Salvizan gel is very effective in the treatment of RAS. It was significantly better than triamcinolone acetonide in the pain recovery and wound healing. These promising results favor herbal treatments and show that they can be used more commonly for treating diseases such as RAS.Trial registrationThis study was approved by the ethics committee of Isfahan University of Medical Sciences (IR.MUI.RESEARCH.REC.1399.834) on 17/03/2021. It was also registered in the Iranian Registry of Clinical Trials (IRCT20100202003251N7).

Comparative study between surgical wound catheter, femoral nerve block, and adductor canal block for postoperative analgesia after knee arthroplasty: A double blind randomized clinical trial.

The present study compared the surgical wound catheter (SWC), femoral nerve block (FNB), and adductor canal block (ACB) for postoperative analgesia after knee arthroplasty. The study included (180) patients scheduled for unilateral total knee replacement and were randomly allocated into three groups. Patients received postoperative analgesia via continuous infusion of ropivacaine 0.2% (10 ml bolus followed by continuous infusion of 5 ml/hour) through the SWC, FNB, or ACB groups. All groups received supplemental analgesia by IV morphine using patient controlled analgesia. Pain scores were assessed at rest and during movements, the worst and least pain scores, and how often were in worst pain during the first 72 hours. The functional activity and patient's satisfaction were also recorded. The study showed significant reductions in pain scores at rest and during movements in all groups compared to the baseline scores. Significant reductions in pain scores were observed in both ACB and FNB groups compared to the SWC group (P < 0.05). The worst pain scores were (6.15 ± 2.9, 5.85 ± 2.7, and 5.025 ± 1.513), least pain scores (2.06 ± 0.72, 1.92 ± 1.34 and 1.89 ± 1.76), percentage of time in worst pain (17.67 ± 9.15, 11.42 ± 7.50, and 9.8.8 ± 8.14) and the total morphine consumption (39.24 ± 6.82, 34.55 ± 7.86, and 26.40 ± 8.47 mg) in the SWC, FNB, and ACB groups, respectively. Functional assessments and patient's satisfaction, at 6 and 24 hours, were significantly better in ACB followed by SWC, and lastly FNB group (P < 0.5). No significant differences in the incidence of side effects (P > 0.05). Local anesthetic leak from the SWC was a continuous concern by the orthopedic surgeons. In terms of efficiency, ACB provided the highest quality of analgesia in terms of pain relief, functional activity, and patient's satisfaction. Both ACB and FNB provided higher quality of analgesia compared to the SWC. While ACB and SWC provided better functional improvements compared to FNB.

Colchicine reduces the activation of NLRP3 inflammasome in COVID-19 patients.

To evaluate whether colchicine treatment was associated with the inhibition of NLRP3 inflammasome activation in patients with COVID-19. We present a post hoc analysis from a double-blinded placebo-controlled randomized clinical trial (RCT) on the effect of colchicine for the treatment of COVID-19. Serum levels of NOD-like receptor protein 3 (NLRP3) inflammasome products-active caspase-1 (Casp1p20), IL-1β, and IL-18-were assessed at enrollment and after 48-72h of treatment in patients receiving standard-of-care (SOC) plus placebo vs. those receiving SOC plus colchicine. The colchicine regimen was 0.5mg tid for 5days, followed by 0.5mg bid for another 5days. Thirty-six patients received SOC plus colchicine, and thirty-six received SOC plus placebo. Colchicine reduced the need for supplemental oxygen and the length of hospitalization. On Days 2-3, colchicine lowered the serum levels of Casp1p20 and IL-18, but not IL-1β. Treatment with colchicine inhibited the activation of the NLRP3 inflammasome, an event triggering the 'cytokine storm' in COVID-19. RBR-8jyhxh.

Prevention of radiotherapy-related oral mucositis with zinc and polyherbal mouthwash: a double-blind, randomized clinical trial

BackgroundA significant percentage of head and neck cancer (HNCs) patients receiving RT experience oral mucositis (OM). This study aimed to evaluate the effect of the polyherbal (containing chamomile, peppermint oil, Aloe vera, and honey) and zinc mouthwashes in comparison to the control (chlorhexidine) and placebo groups for prevention of radiation-induced OM.MethodsThis study was a double-blinded randomized clinical trial, conducted on 67 patients with HNCs undergoing radiotherapy. The eligible participants were randomized to receive either one of the following; zinc sulfate, polyherbal, chlorhexidine (Vi-one 0.2% CHX), or placebo mouthwash for 6 weeks. Follow-up evaluation of oral hygiene and the checklists of OM and the intensity of pain were filled out according to WHO assessment tool, Oral Mucositis Assessment Scale (OMAS), and Visual Analog Scale (VAS) in all the participants weekly for seven consecutive weeks.ResultsThe results of present clinical trial demonstrated that the use of either zinc sulfate or polyherbal mouthwash significantly reduced the scores of OM and the severity of pain during weeks 2 to 7 after consumption compared with the CHX or placebo mouthwashes (P < 0.05). According to the post hoc analysis and compared with the placebo, a significantly better result was reported for zinc sulfate and polyherbal mouthwashes at weeks 2 to 7, but not for the CHX mouthwash.ConclusionThis study showed that the use of zinc sulfate or polyherbal mouthwashes is effective in prevention of both OM severity scores and pain related to OM intensity at weeks 2 to 7 following consumption in HNCs patients.Trial registration IRCT20190123042475N1 and IRCT20190123042475N2. Registration date: 2019-06-09, 2019-07-26.

The effect of conjugated estrogens vaginal cream and a combined vaginal cream of vitamins D and E in the treatment of genitourinary syndrome.

Genitourinary syndrome occurs due to a decrease in ovarian hormones; this can have a significant negative impact on women's interpersonal relationships and sexual function. The present study aimed at comparing the therapeutic effect of conjugated estrogens vaginal cream and a combined vaginal cream of vitamins D and E in the treatment of genitourinary syndrome in postmenopausal women. This study was conducted as a double-blind randomized clinical trial (RCT). As many as 64 postmenopausal women suffering from genitourinary syndrome were randomly divided into study and control groups. The study group was treated with a combined vaginal cream of vitamins D and E, and the control group was treated with conjugated estrogens vaginal creams for 12 weeks. The patients were visited at the beginning of being admitted, the fourth week, the 12th week, and four weeks after the treatment and their information was recorded by checklists and a sexual function questionnaire. The data were finally analyzed by SPSS-25 at a significant level of 0.05. At four visits, libido, orgasm, and frequency of sexual intercourses, as well as vaginal symptoms such as burning, itching, dryness, and dyspareunia were improved in both groups (P <.05). However, there was no difference between the two groups in terms of the frequency of severity of these symptoms during the four visits (P >.05). Investigating the female sexual function index showed that using vitamin D and E vaginal creams, like the use of conjugated estrogens vaginal creams, improves sexual function in women (P <.01). According to the results, it can be concluded that the combined vaginal cream of vitamins D and E is a suitable alternative to vaginal estrogens in relieving the symptoms of genitourinary syndrome in postmenopausal women, especially those who are unable to use hormone therapy or have little compatibility with this therapy.

Abstract P3-03-05: A randomized study assessing interventions to improve comfort during screening mammography

Abstract Background: Although screening mammography leads to an early detection of breast cancer and a reduction in breast cancer mortality, many women have apprehension about mammograms due to reported discomfort and pain [would cite the source]. A study showed that pain was the cause of non-reattendance of screening mammograms in 25-46% of reported cases by women. Despite this, there is limited research on strategies to reduce discomfort and anxiety associated with mammography screening and improve patient experience and compliance with national screening recommendations. Herein, we performed a double-blind randomized clinical study to determine if the use of local analgesia and calming music can improve patient satisfaction during routine screening mammogram. Methods: This study was designed as a double-blind randomized clinical trial with a 2 × 2 factorial design. A total of 251 patients who presented for mammographic screening were randomized to receive: breast lidocaine gel at a dose of 1200 mg or placebo gel on both breast and experience calming music or no music Patients with history of mastectomy, breast cancer or recent (within 24 hours) analgesic use were excluded. Pain was measured with a 5-point face pain scale. Benjamini-Hochberg false discovery rate was used for analysis Results: Of the 251 patients who were randomized between June 2017 and October 2019, 195 self-identified as Hispanics (77%). Median age was 58.5 years old and there were no differences in between groups. 100% were female. 99.3% presented for screening with no concerning symptoms. A total of 126 patients were randomized to music vs 125 to no Music. 79 patients in music group and 51 patients in no music group were randomized to lidocaine. Regarding pain assessment, 18.96% of patients had a pain score of 4 and 5 in the music group randomized to lidocaine gel as opposed to 10.64% to placebo gel. In the non-music group, 17.65% of patients expressed pain score of 4 and 5 to lidocaine gel vs. 18.91% to placebo gel. (P value music: 0.95, P value lidocaine: 0.93 P value music and lidocaine: 1). Patients randomized to lidocaine gel to music reported their prior mammogram to be at a pain score of 4 to 5 in 41.7% of the subjects vs 45% of patients in the no music group. (P value music: 0.45, P value lidocaine: 0.93 P value music and lidocaine: 1). Despite this, majority patients in both groups expressed no reluctance for future mammograms. Conclusion: The addition of calming music and breast lidocaine gel did not show a statistically significant difference in the level of pain perceived by patients getting screening mammography. The data appear to suggest less severe pain (pain score 4 and 5) when these strategies are combined. Further prospective trials with larger patient populations are needed to explore these interventions. Despite the perceived pain most patients were still willing to return for a mammogram the following year. Citation Format: Marcela Mazo-Canola, Heidi C. Ko, Kenneth Kist, Joel Michalek, Lillian Franco, Pamela Otto, Virginia Kaklamani. A randomized study assessing interventions to improve comfort during screening mammography [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-05.