Effectiveness of Topical Sucralfate in the Management of Pressure Ulcer in Hospitalized Patients: A Prospective, Randomized, Placebo-Controlled Trial.

BACKGROUND: The aim of this study was to evaluate the effectiveness of topical sucralfate in the management of pressure ulcer (PU) in hospitalized patients. METHODS: Forty hospitalized patients with stage II PU were included in this prospective, double-blind, randomized, placebo-controlled trial and were randomly divided into 2 groups receiving either sucralfate gel or placebo, on a daily basis. The patients were visited every day for 14 days, the ulcer was evaluated using the Pressure Ulcer Scale for Healing (PUSH) and changes to the measured scores over time were used as an indicator of wound healing. RESULTS: There were no statistically significant differences in any of the demographic characteristics between both groups. Both of the interventions reduced the average PUSH score, and at the end of the trial, all but 2 patients were healed. One in each group discontinued the trial because of exacerbation of the ulcer. No significant between-group difference in the average PUSH score reduction was observed (6.36 ± 2.11 vs. 5.89 ± 1.41, P = 0.42). Although the average healing time was less in the sucralfate group (6.05 ± 2.17 vs. 7.78 ± 3.42), the difference was not statistically significant (P = 0.07). CONCLUSIONS: Sucralfate gel does not improve healing of PU compared with placebo.

Randomized double-blind clinical trial of combined treatment with megestrol acetate plus celecoxib versus megestrol acetate alone in cachexia-anorexia syndrome induced by GI cancers.

PURPOSE: Previous studies reported promising efficacy for celecoxib in the treatment of cancer cachexia. We designed this study to test the hypothesis that combination therapy with megestrol acetate (MA) plus celecoxib is superior to MA alone. METHODS: Ninety eligible gastrointestinal cancer patients randomly received either MA 320 mg/day plus placebo (arm1) or MA 320 mg/day plus celecoxib 200 mg/day (arm2). Patients were evaluated at baseline, then 1 and 2 months after starting interventions. The primary outcome was body weight. Secondary outcomes were quality of life, grip strength, appetite score, performance status, plasma albumin, CRP, IL-6, and Glasgow Prognostic Score. RESULTS: Patients were comparable at baseline. Sixty patients were assessable for the first month and 33 patients for the second month. After 2 months, patients in arm1 (MA + placebo) and arm2 (MA + celecoxib) experienced 4.0 ± 3.4 and 2.2 ± 3.6Kg of weight gain respectively (P = 0.163). Changes relative to baseline were statistically significant in both arms of the study (P = 0.001). Regarding secondary outcomes, comparisons between groups did not show any statistically significant difference, but within-group changes were significant in both arms of the study. CONCLUSION: Since both MA alone and MA plus celecoxib are associated with improvement of cachexia in GI cancer patients, this study failed to show that adding celecoxib (200 mg/day) to megestrol (320 mg/day) could enhance anti-cachexic effects of megestrol.

Topical Minoxidil Versus Topical Diltiazem for Chemical Sphincterotomy of Chronic Anal Fissure: A Prospective, Randomized, Double-Blind, Clinical Trial.

BACKGROUND: Anal fissure is a common anorectal problem causing severe pain and discomfort to the patients. Chemical sphincterotomy has emerged as a noninvasive alternative to the surgical methods of fissure treatment. The objective of this study was evaluation of the efficacy and the adverse effects of topically applied minoxidil in chemical sphincterotomy of chronic anal fissure in comparison with topical diltiazem. METHODS: A total of 88 patients with chronic anal fissure aged between 15 and 65 years were included in this double-blind, randomized clinical trial and were randomly assigned to either 0.5% minoxidil cream or 2% diltiazem cream twice daily for 2 weeks. The pain intensity, bleeding, wound healing, itching, headache, dizziness, significant drop in blood pressure, allergy and fissure relapse were assessed on a monthly basis for 2 months. RESULTS: Both diltiazem and minoxidil reduced the pain, bleeding and improved fissure healing with no significant difference. There were no between-groups differences in the frequencies of adverse effects, except for itching which was slightly higher with minoxidil during the first month. Allergy occurred in two patients in the minoxidil group, which was not severe and did not lead to discontinuation of the trial. CONCLUSION: Topically administered minoxidil is of equal efficacy as diltiazem in the treatment of chronic anal fissure with low frequency of adverse effects. Thus, it can be considered as an agent for chemical sphincterotomy of anal fissure, but the itching at the beginning of the treatment can affect the adherence of the patient to treatment. Trial registration number IRCT2015041414483N6 (the full trial protocol could be accessed online at www.irct.ir ).

Effects of Topical Atorvastatin (2 %) on Posthemorrhoidectomy Pain and Wound Healing: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

BACKGROUND: Atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor widely used in treatment of hypercholesterolemia and prevention of coronary heart disease and has various pleiotropic effects. In this study, the efficacy of atorvastatin emulgel (2 %) in reducing postoperative pain at rest, pain during defecation and analgesic requirement after open hemorrhoidectomy was investigated. METHODS: A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either atorvastatin emulgel or placebo immediately after surgery and then every 12 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of pethidine and acetaminophen consumption, and percent of wound healing. RESULTS: There was no significant difference in the average postoperative pain scores in the first 48 h (P 12h = 1, P 24h = 0.128 and P 48h = 0.079) after the surgery between the two groups, but at the week 1 the pain scores during defecation were considerably lower in the atorvastatin group than in placebo group (P = 0.004), which also was the same at the week 2 (P = 0.03). There was no significant difference in the average pethidine and acetaminophen (mg) administration at 12 h and 24 h between the two groups after surgery. Regarding the data about wound healing, at the week two the healing was much better in the treatment group than it was in control group and the difference was statistically significant (P = 0.04). CONCLUSIONS: Compared with placebo, atorvastatin emulgel reduced postoperative pain at rest and on defecation and could improve the healing process after open hemorrhoidectomy. TRIAL REGISTRATION NUMBER: IRCT201404013014N8.

Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

A triple-blinded, randomized, placebo-controlled trial to examine the efficacy of buspirone added to typical antipsychotic drugs in patients with chronic schizophrenia.

BACKGROUND: The purpose of this study was to test the hypothesis that the addition of buspirone, a partial agonist of 5HT1A receptor, to ongoing treatment with typical antipsychotics would improve the positive and negative symptoms in patients with chronic schizophrenia. MATERIALS AND METHODS: In this study, 50 patients including 40 male and 10 female were recruited with chronic schizophrenia who were inpatients at psychiatric teaching hospital or asylums, aged between 18 and 65 years (mean age = 47 ± 10.02). All patients were on the stable dose of typical antipsychotics for at least 1-month, and their acute symptoms were controlled. Patients were allocated in a random fashion: 25 patients to buspirone at 30 mg/day plus typical antipsychotic and 25 patients to placebo plus typical antipsychotic. The positive and negative syndrome scale (PANSS), Simpson-Angus extrapyramidal rating scale (SAS) and mini mental state examination (MMSE), were administered at baseline, and 2, 4, and 6 weeks after the addition of buspirone. RESULTS: The 30 mg/day buspirone was well-tolerated, and no clinically important adverse effects were seen. There was no statistically significant difference between the two groups in MMSE and SAS scales. There was a significant reduction in subscales of negative, general, positive, and total of PANSS over the 6-week trial in buspirone group. There was a statistically significant difference between the two groups negative subscale (mean ± standard deviation [SD] = 14.08 ± 1.4 in buspirone group) P = 0.0219, general subscale (mean ± SD = 27.42 ± 2.1 in buspirone group) P = 0.0004, and total subscale (mean ± SD = 55.63 ± 3.9 in buspirone group) P = 0.0298, of PANSS in the 6-week of trial. CONCLUSION: The results suggest that adjunctive treatment with 5HT1A agonist such as buspirone may improve the negative symptoms of schizophrenia. Further studies are indicated to determine the efficacy of 5HT1A agonist treatment in chronic schizophrenia.

Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo-controlled trial.

BACKGROUND: The aim of the present study was to evaluate the efficacy of 10 % sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy. METHODS: A total of 48 patients (24 men and 24 women) between 20 and 70 years of age who underwent open hemorrhoidectomy were included in this prospective, double-blind, randomized, controlled trial and were randomly divided into two groups (24 in each group), receiving either sucralfate ointment or placebo immediately after surgery and then every 12 h for 14 days. The primary outcome measure was pain intensity measured by a visual analogue scale at different time points after hemorrhoidectomy. RESULTS: The sucralfate group had significantly less pain than the placebo group at 24th h and the 48th h after hemorrhoidectomy (4 ± 1.14 vs 5.08 ± 0.97; P = 0.001 and 3 ± 0.72 vs 4.41 ± 0.8; P < 0.001, respectively), and they consumed lower amounts of analgesics at the same time intervals (12.50 ± 16.48 vs 21.87 ± 15.30 mg of pethidine; P = 0.047 and 152 ± 23 vs 172 ± 29 mg of diclofenac; P = 0.009, respectively). The same trend continued until the end of the trial. CONCLUSIONS: Sucralfate ointment reduced the acute postoperative pain after hemorrhoidectomy.

Efficacy of cholestyramine ointment in reduction of postoperative pain and pain during defecation after open hemorrhoidectomy: results of a prospective, single-center, randomized, double-blind, placebo-controlled trial.

BACKGROUND: The aim of the present study was to evaluate the efficacy of cholestyramine ointment (15 %) in reducing postoperative pain at rest and during defecation after open hemorrhoidectomy. METHODS: A total of 91 patients with third and fourth degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either cholestyramine ointment or placebo immediately after surgery, 12 h after surgery, and then every 8 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of tramadol consumption. RESULTS: The cholestyramine group had less postoperative pain than the placebo group at the 24th hour (1.84 ± 2.54 vs. 4.07 ± 3.35; P = 0.001) and 48th hour (0.18 ± 0.88 vs. 3.57 ± 3.45; P < 0.001) and less pain during defecation starting at the 48th hour (2.28 ± 2.96 vs. 4.77 ± 4.09; P = 0.001). Similarly, the average tramadol consumption at hours 24 and 48 was significantly lower for the cholestyramine group (5.32 ± 21.45 vs. 43.18 ± 61.56 mg at 24 h, and 4.48 ± 16.65 vs. 57.63 ± 65.47 mg at 48 h; P < 0.001). The only adverse event was pruritus, which had a lower frequency in the cholestyramine group but the difference was not significant until postoperative week 4 (P < 0.001). CONCLUSIONS: Compared with placebo, cholestyramine ointment (15%) reduced postoperative pain at rest and on defecation, and consequently lowered the analgesic requirement after open hemorrhoidectomy.

Acute pancreatitis following COVID-19 vaccine: A case report and brief literature review.

Vaccination is the most effective way to overcome COVID-19 morbidity and mortality. However, Covid-19 vaccines may cause potential adverse effects. We reported a 28-year-old healthy woman who was referred to the emergency department with a chief complaint of severe abdominal pain, nausea and hemoptysis. She has received two doses of COVID-19 vaccine (Sinopharm BIBP). Similar this time, three days after the injection of the second dose of the Sinopharm BIBP COVID-19 vaccine, abdominal and flank pain appeared, for which she has referred to the emergency department. After necessary tests and pancreatitis was confirmed, we started fluid therapy, plasmapheresis, gemfibrozil and insulin for patient management. The COVID-19 vaccines may lead to acute pancreatitis. The mechanism of pancreatitis caused by COVID-19 vaccines is unclear. Acute pancreatitis can develop after COVID-19 vaccination. This process can even happen a few months later. Therefore, to better diagnosis and prevention of long-term complications, it is necessary to measuring the lipase or amylase in patients that received COVID-19 vaccine if abdominal pain was occurred.

Efficacy and safety of adding fluoxetine to the treatment regimen of hospitalized patients with non-critical COVID-19 pneumonia: A double-blind randomized, placebo-controlled clinical trial.

INTRODUCTION: Selective serotonin reuptake inhibitors are considered the drugs, whose effectiveness in viral pandemics has been studied. The aim of this study was to evaluate of adding fluoxetine to the treatment regimen of patients with COVID-19 pneumonia. METHODS: This study was a double-blind randomized placebo controlled clinical trial .36 patients in the fluoxetine and 36 patients in the placebo group were enrolled. Patients in the intervention group were first treated with fluoxetine 10 mg for 4 days and then the dose of 20 mg was continued for 4 weeks. Data analysis was conducted using SPSS V. 22.0. RESULTS: There was no statistically significant difference between the two groups in terms of clinical symptoms at the beginning of the study and also the score of anxiety and depression, oxygen saturation at the time of hospitalization, mid-hospitalization and discharge periods. The need for mechanical ventilator support (p = 1.00), the need for admission in the intensive care unit (ICU) (p = 1.00), rate for mortality (p = 1.00), and discharge with relative recovery (p = 1.00) were not significantly different between the two groups. The distribution of CRP within the study groups showed a significant decrease during different time periods (p = 0.001), and although there was no statistically significant difference between the two groups on the first day (p = 1.00) and at discharge (p = 0.585), mid-hospital CRP showed a significant decrease in the fluoxetine group (p = 0.032). CONCLUSION: Fluoxetine resulted in a faster reduction of patients' inflammation without association with depression and anxiety.

Effect of atorvastatin 1% mouthwash in the prevention of radiotherapy induced mucositis: A pilot study.

Background: Oral mucositis is a troublesome symptom for people who receive radiotherapy and chemotherapy and it is a dose-dependent factor. Atorvastatin is a HMG-CoA reductase inhibitors and various studies have proven its anti-inflammatory effects. The goal of this study was to evaluate atorvastatin 1% mouthwash effects in prevention of radiotherapy-induced mucositis. Methods: Atorvastatin 1% suspension was prepared for mouthwash in this randomized, double-blind clinical trial. Thirty patients randomly received atorvastatin or placebo mouthwash. They had to gargle 5cc of mouthwash, 3 times per day during radiotherapy. The severity and pain of mucositis was evaluated every week, during their treatment. Results: The severity of mucositis between the two study groups was significant every four weeks (p<0.05) and the percentage of patients with more severe mucositis was less in the atorvastatin group. It is found that the pain intensity was lower after 3 and 4 weeks in atorvastatin group. Conclusion: These findings indicated that atorvastatin mouthwash showed a significant activity in relieving of radiotherapy-induced oral mucositis and pain.

Effect of melatonin on stress-induced hyperglycemia and insulin resistance in critically-ill patients: A randomized double-blind, placebo-controlled clinical trial.

BACKGROUND: Hyperglycemia is a common finding which is associated with increased mortality and morbidity among critically ill patients. There is currently no evidence that melatonin could improve stress induced hyperglycemia (SIH). In this study, we evaluated the effect of melatonin on blood sugar and insulin resistance (IR) in critically-ill patients. METHODS: 104 critically-ill patients with SIH divided into two groups, receiving melatonin (6 mg BD for 3 days) or placebo. Changes of blood sugar, IR indices including homeostasis model assessment for insulin resistance and homeostasis model assessment adiponectin (HOMA-AD) ratios, Glasgow coma scale (GCS) were evaluated on the 4th day of melatonin prescription. On the 7Th day of study, changes of ventilator dependency and delirium were considered. Mortality and intensive care unit (ICU) stay were also compared between groups. RESULTS: On day 4, patients in the melatonin group had significantly lower blood glucose and HMOA-IR level compared with the placebo group (P=0.04 and P=0.03, respectively) whereas HOMA-AD level did not differ significantly from placebo group (p>0.2). Also, we did not observe any significant difference in GCS level at this time between groups (p>0.2). On day 7, melatonin could not improve ventilator dependency and delirium significantly (p>0.2) and also could not reduce mortality and ICU stay in comparison with placebo (p>0.2, P=0.2, respectively). CONCLUSION: Melatonin supplementation showed positive effect on blood sugar and somehow insulin resistance whereas it could not improve ICU complications.

The comparison of the effect of flaxseed oil and vitamin E on mastalgia and nodularity of breast fibrocystic: a randomized double-blind clinical trial.

BACKGROUND: Fibrocystic changes are a common benign condition in women aged 20-50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast's pain and tenderness. In the long-term, reversing the fibrocystic changes is also desirable. METHODS: In this randomized double-blind clinical trial, the effect of flaxseed oil on the severity of pain and breast nodularity was investigated against vitamin E. This study was conducted on 100 women with mastalgia. The intervention group received Flaxseed oil pearls and the control group received vitamin E pearl 200 IU twice a day for 2 months. The duration and severity of breast pain were evaluated by Cardiff chart and VAS (Visual Analogue Scale). The nodularity was assessed by Lucknow-Cardiff scale at baseline, then the first and second months of intervention. RESULTS: At baseline, there was no statistically significant difference between the two groups in characteristics. The breast pain improved in both groups during the first and second months of intervention (P-value within group< 0.001). However, the mean breast pain was not significantly different between the two groups at the end of the first and second month (P1= 0.54, P2= 0.73). Furthermore, the breast pain during four phases of the menstrual cycle showed no difference between vitamin E and flaxseed oil groups (menstruation phase= 0.76, follicular phase= 0.48, the first week of luteal phase= 0.86, the second week of luteal phase=0.30). The breast nodularity also decreased during the first and second months of intervention, yet no significant difference between the two groups was found (p= 0.9). CONCLUSIONS: This study showed that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity with minimal side effects in contrast with the baseline. But there are no significant differences between these two agents. Larger scale prospective studies are needed to evaluate these effects in the long-term. TRIAL REGISTRATION: IRCT201612243014N18 , Registration date: 2017-10-15.

Clinical Effectiveness of a High Dose Versus the Standard Dose of Meropenem in Ventilator-associated Pneumonia Caused by Multidrugresistant Bacteria: A Randomized, Single-blind Clinical Trial.

BACKGROUND: Meropenem standard doses are based on the minimum inhibitory concentration of sensitive pathogens and the pharmacokinetic parameter of not critically ill patients. We compared the efficacy of high versus standard dose of meropenem in ventilator-associated pneumonia (VAP). ; Methods: 24 out of 34 eligible patients were randomized to receive meropenem 3 g q8h (high dose group, 11 patients) or 2 g q8h (standard-dose group, 13 patients) as a 3h infusion. The primary outcome was considered as clinical success that was defined as stable hemodynamic, improved sequential organ failure assessment (SOFA) score, stable or improved PaO2/FiO2 after 7 days. Sputum culture was taken before the intervention. ; Results: Clinical success rate was not significantly different between the high and standard-dose group (54.5% vs. 38.5%, P= 0.431). There was a significant difference in the reduction of clinical pulmonary infection score (CPIS) compared to a high dose to the standard group (P=0.038). SOFA score declined significantly in the high dose group throughout the study (P=0.006). A shorter duration of VAP treatment was recorded in the high dose group (P=0.061). We did not observe any significant adverse event related to meropenem. Acinetobacter spp. (34.8%), Klebsiella spp. (32.6%) and Pseudomonas aeruginosa (19.5%) isolated more frequently from sputum cultures. ; Conclusion: Treatment with the high dose of meropenem seems to be safe. However, it did not provide a significantly higher clinical success rate in comparison with the standard dose, but could be considered as an appropriate empirical treatment in patients with severe infection due to reduction in SOFA and CPIS. ; The trial protocol was registered with IRCT.ir (registration number IRCT2010010700 3014N19 in April 2018).

Comparison of the Efficacy and Safety of Atazanavir/Ritonavir Plus Hydroxychloroquine with Lopinavir/Ritonavir Plus Hydroxychloroquine in Patients with Moderate COVID-19, A Randomized, Double-blind Clinical Trial.

This was a randomized, double-blind clinical trial to compare the efficacy and safety of Atazanavir/Ritonavir (ATZ/RTV) with Lopinavir/Ritonavir (LPV/RTV) in moderate Coronavirus disease 2019 (COVID-19). Participants were randomly assigned to receive a single dose of hydroxychloroquine (HCQ) plus ATZ/RTV or LPV/RTV for a minimum of 5 to a maximum of 10 days. The primary outcomes were the reduced length of hospital stay and clinical recovery within 10 days from starting the intervention. The rate of intensive care unit (ICU) admission, intubation, and mortality, the lengths of ICU stay and being intubated, recovery within 14 days, and the frequency of adverse reactions were considered as secondary outcomes. Among 132 enrolled patients, 62 cases in each arm were analyzed at the end of the intervention. Fifty-one (82.3%) cases in the ATZ/RTV arm versus 41 (66.1%) in the LPV/RTV arm were discharged within 10 days (P = 0.06). The median number of the intervention days was 6 (IQR: 5-8) in ATZ/RTV arm versus 7 (IQR: 6-9) in LPV/RTV arm (P = 0.01). The rate and length of ICU admission and intubation (P ≥ 0.99), rate of mortality (P = 0.49), and recovery within 14 days (P = 0.09) were not statistically different between groups. The most reported adverse reactions were nausea and vomiting that all cases were in the LPV/RTV arm (P = 0.006). ATZ/RTV is better tolerated in comparison with LPV/RTV; however, it did not show more efficacy than LPV/RTV in clinical outcomes of COVID-19 in this study.

Tocilizumab for treatment patients with COVID-19: Recommended medication for novel disease.

The coronavirus disease 2019 (COVID-19) virus has spread all over the world. Scientists are trying to discover drugs as effective treatment for patients with COVID-19. So far about 30 drugs have been introduced that one of them is Tocilizumab. Recently Tocilizumab has been introduced to treat patients with COVID-19 and researchers are investigating further the efficacy of this drug for different are patients. In Iran and China, some reports showed a positive effect of Tocilizumab on Saturation of Peripheral Oxygen (SPO2) but results of CT scan in patients in different. In some patients, CT scan showed reduced infiltration, however in other no change was observed. Unfortunately, until now there has been no definitive and effective treatment for patients with COVID-19. Although Tocilizumab has been accepted by China Health Commission to treat infected patients, its positive effects still cannot be predicted in all patients. Based on evidence of the Tocilizumab's effect on the SARS COV 2, researchers hope this drug will make effective and promising treatment to improve lung tissue inflammation in patients with the fatal COVID-19 virus. The present study provides an overview of respiratory inflammation with COVID-19 and probable effect of Tocilizumab on SARS-COV 2.

Evaluating the Effect of Dexmedetomidine on Hemodynamic Status of Patients with Septic Shock Admitted to Intensive Care Unit: A Single-Blind Randomized Controlled Trial.

Septic shock, known as the most severe complication of sepsis, is a serious medical condition that can lead to death. Clinical symptoms of sepsis include changes in body temperature in the form of hypothermia or hyperthermia, tachypnea or hyperventilation, tachycardia, leukocytosis or leukopenia, and variations in blood pressure, as well as altered state of consciousness. One of the main problems in septic shock is poor response along with reduced vascular reactivity to vasopressors used to increase blood pressure. Therefore, low vascular response associated with reduced sensitivity or lower number of alpha-1 agonist receptors can result in shock and death. In addition to being the state-of-the-art treatment including volume load and vasopressor, use of alpha-2 agonists e.g. dexmedetomidine (DXM) in septic shock can reduce vasopressors needed to restore adequate blood pressure. They can further moderate massive release of endogenous catecholamine. Therefore, the purpose of this study was to investigate the effect of DXM on outcomes of patients with septic shock, especially their needs for vasopressors and impacts on their hemodynamic status. This single-blind randomized controlled trial was performed on a total number of 66 patients with septic shock admitted to the intensive care unit (ICU) of Imam Khomeini Teaching Hospital in the city of Sari, in northern Iran. To this end, DXM (0.6 µg/kg/h) and normal saline (6 mL/kg/h) were infused for 12 h in the study and control groups, respectively. The results revealed that DXM could increase mean arterial pressure (MAP) (P = 0.021), systolic blood pressure (SBP) (P = 0.002), and reduced heart rate (P < 0.001) but diastolic blood pressure (DBP) (P =0.32) and norepinephrine dose requirement didn't change statistically in septic shock patients (P = 0.12).

Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.

BACKGROUND: Baclofen is an agonist for a subtype of gamma-amino butyric acid (GABA-B) receptors and traditionally been used for the systemic treatment of spasticity. Topical application of baclofen has been shown to reduce pain in patients with localized neuropathic pain. OBJECTIVES: In this study, we investigate the efficacy of baclofen cream (5%) in reducing postoperative pain and analgesic requirement after open hemorrhoidectomy. DESIGN: The patients were randomly assigned to either baclofen (5%) cream or placebo immediately after surgery and then every 12 h for 14 days. PATIENTS: A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were randomly assigned to this trial. SETTING: This study was conducted at a single educational hospital. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption. RESULTS: No significant difference was found in baseline characteristics between the two groups. Postoperative pain score of the baclofen group was significantly lower on week 1 (P = 0.01) and week 2 (P = 0.02) than the placebo group. Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group. CONCLUSION: Topical application of baclofen effectively relieves pain after hemorrhoidectomy with minimal side effects.

Evaluation of Cholestyramine 15% Ointment in Relieving Pruritus and Burning After Ileostomy: A Rrandomized, Double-Blind Placebo-Controlled Clinical Trial.

Purpose/Aims: Skin irritation is a common ileostomy problem that causes burning and pruritus among patients due to the leakage of intestinal discharge around the stoma. This clinical trial was performed to evaluate the efficacy of topical cholestyramine (15%) on the reduction of the levels of burning and pruritus after an ileostomy. Material and methods: The patients were randomly divided into two groups of treatment and control (n = 15). The intervention group was subjected to one fingertip of cholestyramine, whereas the other group received the placebo ointment (approximately 0.5 g) on the skin immediately after the surgery and twice a day for 2 months. The primary outcome measure was the severity of burning and pruritus measured by a visual analog scale at different times after an ileostomy. Results: Out of 34 patients, four cases were excluded due to the inappropriate completion of the questionnaire (n = 2) and unwillingness to attend the follow-up visits (n = 2). Therefore, 30 patients were included in the study. The levels of burning among patients in the cholestyramine were lower in weeks 3, 4, and 8 compared to the placebo group. Moreover, lower levels of pruritus were observed among patients in the treatment group in weeks 4 and 8 after an ileostomy. No side effects were reported among the patients. Conclusions: Topical cholestyramine was found to be effective in the management of burning and pruritus resulting from an ileostomy among the population under study.