Blind Randomized Control Trial Research Articles

Comparing palonosetron and lignocaine pretreatment with venous occlusion on reducing rocuronium associated withdrawal movements. A double blinded randomized control trial

Introduction: Use of rocuronium has been associated with withdrawal movements of injected arm during its administration. Our study is to compare the effectiveness of palonosetron vs. lignocaine pretreatment with venous occlusion on reducing withdrawal movements associated with rocuronium injection. Materials and Methods: This prospective randomized double blind trial includes 150 patients aged between 18 and 65 years undergoing elective day-care surgeries. Patients were randomly divided into 3 groups of 50 patients each with assistance from computer generated random number table. Group P received palonosetron 075mg, Group L received Lignocaine 30 mg and Group S received Normal saline as pretreatment. The degree of withdrawal of limb was graded on four-point scale. Haemodynamic changes namely HR and MAP following administration of study drugs and complications following administration of the study drugs like urticaria, wheal and rash were also monitored. Results: Overall incidence of rocuronium induced withdrawal movements was significantly more in-group S (84%) than other study groups (p Conclusion: Study demonstrated that palonosetron pretreatment and venous occlusion has reduced rocuronium induced withdrawal movements more effectively than lignocaine. Keywords: Palanosetron, Rocuronium, Withdrawal movements, Lignocaine.

Mifepristone for cervical ripening and induction of labour

Objective: To study the efficacy of oral mifepristone in pre induction cervical ripening and induction of labour in term pregnancy. Materials and Methods: This is a single blind randomised control trial. 200 women with term pregnancy and bishop score < 6 were recruited and randomly allocated into two groups. Women who received tablet mifepristone 400 mg were assigned to study group (n=100) and who received placebo orally were assigned to control group (n=100). At the end of 48 hours, change in the bishop was assessed and accordingly induction/ augmentation of labour was done. Analysis regarding safety and efficacy of the drug was done with regards to maternal and perinatal outcome. Results: Among 200 women, 100 received mifepristone and 100 received placebo. In mifepristone group, 75% patients entered into labour within 48 hours of induction as compared to 48% in placebo group. The mean time interval between induction to start of labour pains was 28 hours 54 min in group A and 42 hours 18 min in group B. This difference was statistically significant. (p=0.000). In the study group 70% patients delivered within 48 hours of treatment as compared to 38% patients in control group. Mean induction delivery interval was 35 hours 38 min in study group and 49 hours 52 min in control group (p=0.000). There were fewer caesareans in the mifepristone treated group (10%) than placebo group (20%) particularly for failed induction (2 versus 6) and non progress of labour (2 versus 5). There was no statistically significant different in perinatal outcome between two groups. Conclusion: Mifepristone has modest affect on cervical repining when given 48 hour prior to labour induction and appears to reduce need for further induction compared to placebo. Mifepristone is a simple and effective method of inducing labour in women with term pregnancy and unripe cervix. The use of Mifepristone provides an interesting new alternative to classic uterotonic agents when induction of labour is neces

Average Level Of Evidence Of Papers Published In Six Orthopedic Journals

Background&#x0D; An assessment of the average level of evidence (LOE) of clinical research papers in peer reviewed orthopedic surgery journals has not previously been published. In this paper we report on the average LOE of papers published in six of the top English language orthopedic surgery journals.&#x0D; &#x0D; Methods&#x0D; Six well established orthopedic journals were identified by using the Google Scholar H5 Journal Index. We selected 6 of the top ten journals identified by the Index. The six journals that were evaluated for this project were as follows: The American Journal Of Sports Medicine (AJSM); Clinical Orthopedics and Related Research (CORR); Journal of Bone and Joint Surgery (JBJS); Knee Surgery, Sports, Traumatology, Arthroscopy (KSSTA); Journal of Arthroscopy (Arthros.); and the Journal of Shoulder and Elbow Surgery (JSES). Thirteen consecutive monthly issues (July, 2018 - July, 2019) of each journal were evaluated for the LOE of each clinical paper. The assigned LOE was used if published, or the level of evidence was assigned by the senior author (DAB) if one was not listed. For each journal, the overall mean LOE along with the variance and standard deviation was calculated with all confidence intervals set at 95%. Summary data was statistically analyzed to provide an overall mean LOE for the 6 journals evaluated.&#x0D; &#x0D; Results &#x0D; For AJSM, we evaluated 246 clinical research articles that had an average LOE of 2.96 +/- 0.16. For CORR, we evaluated 155 papers that had an average LOE of 2.83 +/- 0.19. For JBJS, we evaluated 164 papers that had an average LOE of 3.04 +/- 0.13. For KSSTA, we evaluated 402 papers that had an average LOE of 3.05 +/- 0.16. For Arthros. we evaluated 226 papers that had an average LOE of 3.19 +/- 0.10. For JSES, we evaluated 237 papers that had an average LOE of 3.25 +/- 0.13.&#x0D; In summary, for the 1425 clinical research papers published in 98 issues of 6 of the top orthopedic journals, we found the average Level Of Evidence to be 3.05 +/- 0.16. &#x0D; &#x0D; Conclusions&#x0D; The goal of scientific study design is to prove or disprove a hypothesis while minimizing bias and errors. The gold standard for therapeutic studies has been a double blind, randomized controlled trial (RCT). However, it is not possible or feasible for every clinical study to have a blinded RCT design. Additionally, clinically relevant and actionable data can come from studies that are not RCTs. In a medical discipline like orthopedics many interventions are invasive, making controlled trials or blinded trials unethical or technically not practical. Our analysis of over 1400 peer reviewed publications in one year in 6 of the top English language orthopedic journals reveals that the average level of evidence deemed worthy of publication is level 3. In terms of the most common study design, the average published clinical study in these orthopedic journals was a case-control study.

Efficacy of Low Daily Dose of Tadalafil as Mono-Therapy for Diabetic Patients With Lower Urinary Tract Symptoms Suggestive of Benign Enlargement of Prostate

Objective: To assess efficacy of tadalafil or tamsulosin versus placebo for LUTS/BEP. Methods: This was a triple blind randomized control trial (RCT). This study was done on 150 cases of well controlled diabetic patients with LUTS/BEP after screening. The patients were &gt;45 years of age, international prostate symptom score (IPSS) &gt; 13, maximum urine flow rate (Qmax) 10-15 ml/sec. Selected patients were randomized in to 1:1:1 ratio to once-daily tadalafil 5 mg, tamsulosin 0.4 mg, or placebo for 12 weeks. Efficacy measures were assessed by IPSS, Qmax, post-voidal residue (PVR) in ultra-sonogram. Results: IPSS significantly improved versus placebo through 12 wk with tadalafil (-4.81; p&lt;0.001) and tamsulosin (-4.03; p&lt;0.001) and as early as 1 wk (tadalafil -2.04; p=0.001 and tamsulosin -2.14; p &lt; 0.001). The IPSS Quality-of-Life Index improved significantly versus placebo with tadalafil (p&lt;0.001) and with tamsulosin (p&lt;0.001) but outcome was better with tadalafil. Qmax increased significantly versus placebo with both tadalafil (6.52 ml/s; p&lt;0.001) and tamsulosin (6.64 ml/s; p&lt;0.001). Adverse event profiles were consistent with previous reports. Conclusion: Monotherapy with 5 mg daily tadalafil or 0.4 mg daily tamsulosin resulted in significant and similar improvements versus placebo in IPSS+QOL in diabetic patients with LUTS/BEP staring from week one and maintained throughout the week 12. It However, Tadalafil also significantly improve Qmax. The adverse event profile was minimal and consistent with those previously reported with these drugs. Bangladesh Journal of Urology, Vol. 20, No. 1, January 2017 p.18-25

Efficacy of Lidocaine and Ketamine Combination on Reduction of Pain Intensity, Improvement of Functional State and Central Desensitization of Chronic Low Back Pain

Abstract&#x0D; Background: Chronic low back pain (LBP) prevalence is approximately 20% of world population. Central and peripheral sensitization are considered as the main mechanism of pain chronification. This study hypothesize that lidocaine and ketamine combination reduces pain intensity, improves functional state and central desensitization of chronic low back pain. It is by modulating central sensitization in sub-anesthetic dose, prolonging inactivation of Na-channel, blocking NMDA-receptor and preventing secondary hyperalgesia.&#x0D; Aim of study: To evaluate the efficacy of lidocaine and ketamine combination on the intensity of pain, functional state and central desensitization of chronic low back pain.&#x0D; Methods:. This double blind randomized control trial study was carried out in Mohammad Hoesin General Hospital, Palembang, Indonesia from May 2018 to January 2019. A total of 20 patients with low back pain that last for more than 3 months, aged &gt;18 years old, of either sex who were willing to be enrolled in this study, were randomly allocated into one of the two groups of 10 each. The treatment group (n=10) received standardized therapy (analgesic and physiotherapy) + intravenous ketamine 0.5 mg/kg + lidocaine 2 mg/kg and the control group (n=10) received standardized therapy + 100 ml Nacl 0.9%. Pain intensity, functional state, and central desensitization were measured before the treatment, day 7 after treatment, and a month after treatment using Numeric Pain Rating Scale (NPRS), Functional Pain Scale (FPS), and Central Sensitization Inventory (CSI).&#x0D; Results: The administration of ketamine 0.5 mg/kg + lidocaine 2 mg/kg resulted in NPRS and CSI changes was effective since the 7th day post intervention (p-value=0.021 and p-value=0.001) while on FPS changes, it was effective since the 30th day post intervention (p-value=0.000)&#x0D; Conclusion: From the result, it could be concluded that the administration of ketamine and lidocaine is effective on decreasing pain intensity and central desensitization in chronic LBP.

Comparative Evaluation of Antiplaque Effectiveness of Ayurvedic And Fluoridated Toothpaste– A Single Blind Randomized Control Trial.

Comparative Evaluation of Antiplaque Effectiveness of Ayurvedic And Fluoridated Toothpaste– A Single Blind Randomized Control Trial.

A double blinded comparative study between omega 3 fatty acid infusion versus octreotide infusion in acute pancreatitis

Background: Over decades the treatment of acute pancreatitis remains debatable with no common consensus on treatment guidelines, with some workers using octreotide infusion and some workers only relying on fluid therapy and symptomatic management. This double blinded comparative trial between omega 3 fatty acid infusion versus octreotide infusion and its response in cases of acute pancreatitis. Methods: This is a study where a double blinded randomised control trial was undertaken in proven cases of acute pancreatitis and patients were given omega 3 fatty acid infusion and octreotide infusion and the observations were documented and followed upon. 50 cases were given omega 3 fatty acid infusion and other 50 were given octreotide infusion and the clinical response, symptomatic improvement was assessed and compared using BISAP and Marshal scoring systems and lipase levels.Results: Omega 3 fatty acid infusion was found to be highly significant as compared to octreotide in cases of acute pancreatitis in terms of clinical improvement, reduced hospital stay, and SIRS.Conclusions: Omega 3 fatty acid infusion is the future in cases of acute pancreatitis which is cheap and easily available with no side effects and reduces the morbidity and mortality in acute pancreatitis with reduced hospital stay in turn resulting in overall reduced medical expenditure.

Effectivity Comparison of Ketamine and Morphine as Post-Operative Analgesic in Spinal Surgery

Introduction: Patients who undergo spinal procedure, experience the post-operative pain as the major problem. From the Visual Analog Scale (VAS), patients scale their pain around 8. An inadequate pain management could fasten the healing process and reduce patient life quality. Opioid group as the gold standard still inflicts several problems, such as respiratory depression. Moreover, the combination NSAID and opioid which used to suppress the side effect, still burden the healthcare cost. In a research of analgesic, through the discovery of N-Methyl D Aspartate receptor, researchers found an explanation of the ketamine effect in relieve chronic and intense pain which safer and cheaper. Method and Material: This research using single blind randomized control trial. Comparing 0.25mg/kg ketamine IV followed by ketamine 0,1mg/kg/h for the intervention group and 0.02mg/kg/h of morphine for the control group to manage the first 24 hours pain sensation. If patient VAS was more than 4, patient would get additional 0.5mg/kg ketamine (intervention group) and 25μg fentanyl (control group). Result and Discussion: From 17 patients each groups, the VAS values were better in control group rather than on intervention group. Low dose ketamine can’t be compared with morphine to manage post spinal procedure pain. There were no hemodynamic changes, respiratory rate depression, loss of consciousness and hallucination, nystagmus, vomiting and hyper salivation. Even though 11.8% of the subject were nausea. The morphine group tends to experience hemodynamic changes and loss of consciousness in the first 12 hours but still within normal range. In the control group, 47.1 % patients were having nausea in the first hour, but only 17.6% of them who actually vomited. Conclusion: The analgesic effect of morphine is higher than ketamine, but the amount effect of ketamine is lower than morphine so that ketamine is more effective and safer given in the room.

Hydrodissection for improved microsurgical denervation of the spermatic cord: prospective blinded randomized control trial in a rat model.

Microsurgical denervation of the spermatic cord (MDSC) can provide up to an 86% improvement in pain in patients with chronic orchialgia (CO) who have failed conservative management. Failures in MDSC could be due to small diameter nerves (≤1 mm) left behind on the spermatic cord. The objective of this study was to assess if hydrodissection (HD) of the spermatic cord after MDSC could decrease the number of residual nerve fibers without compromising blood flow. Prospective blinded randomized control trial: bilateral MDSC was performed on 22 adult rats (44 cords). HD of the spermatic cord was performed on one side of each rat (side randomized) using the ERBEJET2. The contralateral cord (no HD) was the control for each animal. Blood flow through the vessels was monitored using a micro-Doppler probe. After completion a cross-section of the residual cord was sent to pathology (blinded to technique) to assess for small diameter nerves and signs of damage in vascular integrity. Blood flow had been maintained in the vessels when the ERBEJET2 was set to 6 bar (87 psi). The cord where HD had been performed had a significantly lower total median residual nerve count of 5 (0-10), compared to 8 (2-12) on the non-HD side (p = 0.007). No structural damage was seen in the vessels in the spermatic cord that had undergone HD (gross exam and histology). HD of the spermatic cord significantly decreases residual nerve density without compromising vascular integrity in a rat model.

Investigating the impact of open label design on patient-reported outcome results in prostate cancer randomized controlled trials.

BackgroundWhile open‐label randomized controlled trials (RCT) are common in oncology, some concerns have been expressed with regard to Patient‐Reported Outcomes (PRO)‐based claims stemming from these studies. We aimed to investigate the impact of open‐label design in the context of prostate cancer (PCa) RCTs with PRO data.MethodsRandomized controlled trials of PCa with a PRO endpoint published between 2004 and 2018 were considered. RCTs were systematically evaluated on the basis of previously defined criteria, including international PRO reporting quality standards and the Cochrane Collaboration's tool for assessing Risk of Bias. The rate of concordance was estimated and compared between traditional clinical outcomes (eg, survival or tumor response) and PRO in open and blinded RCTs.ResultsWe identified 110 RCTs published between 2004 and 2018, of which 62% (n = 68) were open‐label. The general characteristics of PCa RCTs were not different according to their design (open‐label vs blinded). The proportion of PCa RCTs with high‐quality PRO reporting was not different between open‐label RCTs and blinded RCTs (41.2% vs 38.1%; P = .75). No statistically significant difference was found between PRO results and concordance with traditional clinical outcomes according to the study design.ConclusionOur findings suggest that there is no evidence of significant bias for PROs due to the absence of blinding in the context of PCa RCTs. Further analyses should be conducted in other cancer disease sites.

Evaluation of Intranasal Administration of Dexmedetomidine during Therapeutic Extraction

Aim: The purpose of this study was to evaluate the effectiveness of intranasal administration of dexmedetomidine during therapeutic extraction.Materials and Methods: The study design is a split mouth double blinded randomized control trial. Patients who visited the department of oral and maxillofacial surgery for the therapeutic extraction of premolars were assessed for enrollment. Each subject participated in two surgical sessions, with the extraction of premolars of the upper and lower quadrant of the same side during a single session. A week later subjects were asked to report back for the extraction of the upper and lower premolar on the contralateral side. The patients were randomized by a computer generated number into two groups. Group A received intranasal dexmedetomidine (100 mcg/ml) and group B received intranasal saline at the first session. An alternate regimen was used during the second session during which group A received intranasal saline and in group B intranasal dexmedetomidine was administered. A mucosal atomization device was used to deliver the drug. Pain from local anesthesia infiltration was rated on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Sedation status was measured using the Observer's Assessment of Sedation. Blood pressure and heart rate of the patient were also monitored.Original Research ArticleXavier et al.; JPRI, 32(18): 112-119, 2020; Article no.JPRI.59782113Results: A total of 14 patients were involved in the study. Observer assessment scale indicated that significant sedation was obtained in group A when compared to group B. Compared to group B there was a significant reduction in heart rate and blood pressure in group A at the end of 10 minutes and 40 minutes. These parameters were normalized to the baseline at the end of 60 minutes. There was no significant difference in pain score noted during the local anesthesia infiltration. None of the patients had bradycardia, hypotension, and respiratory depression in this trial.Conclusion: In this study, we conclude that the intranasal administration of dexmedetomidine controls the patient's fear and anxiety during the therapeutic extraction but not the pain during the administration of local anesthesia.

Effect of pre-incisional infiltration of 0.5% ropivacaine versus placebo in post-operative pain relief among patients undergoing tonsillectomy under general anaesthesia: a comparative study

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; Pain is the most common complaint in the immediate post-tonsillectomy period. Inadequate post-tonsillectomy pain management has many drawbacks. Ropivacaine is a new long acting local anaesthetic, structurally closely related to bupivacaine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;It was a prospective double blinded randomized control trial on a total of 50 patients who were posted for tonsillectomy. Randomization of each patient was done into two groups one of which had received 4 ml of 0.5% ropivacaine hydrochloride solution and other 4 ml normal saline. Data entry and analysis was done with (SPSS IBM) version 21.0. Both univariate and bivariate analysis done. Proportions were calculated for qualitative variables and mean with standard deviation was done for quantitative variables. Required tests of significance such as Chi square test and independent test were applied. Significance of p value is taken as p&amp;lt;0.05. Postoperative pain, first post op oral intake, duration of post-operative hospital stay, and postoperative haemorrhage was assessed. The intensity of postoperative pain was assessed on behavioural observational pain Scale and Wong baker faces pain rating scale.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; Pre-incisional infiltration of 0.5% Ropivacaine was an effective method to reduce post-operative pain in patients undergoing tonsillectomy under GA. Effect of Ropivacaine was statistically significant (p&amp;lt;0.05).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; We recommend the use of 0.5% ropivacaine pre-incisional infiltration in patients undergoing tonsillectomy.&lt;/p&gt;

Effect of polyethylene cover on the treatment of exposure keratopathy in ICU.

Exposure keratopathy may lead to serious complications such as microbial keratitis, corneal perforation, and visual impairment if not treated. To compare the effect of carbomer eye drops when used alone and in combination with polyethylene covers in the healing of exposure keratopathy. A single blind randomized-controlled trial (RCT) in two intensive care units (ICUs) was carried out in a university hospital in Western Turkey between September 2011 and December 2012. The control group received only carbomer, eye drops while the intervention group received both carbomer eye drops and polyethylene covers. The primary outcome was the decrease or absence of corneal damage, which refers to healing. Corneal damage was followed up with a fluorescein dye test (decrease/absence of the corneal staining) by the same ophthalmologist for 10 days. A total of 43 corneas in 24 patients were studied. Corneal epithelial defects decreased in the intervention group by day 2 and progressed or remained unchanged in the control group every day (P= .001). Patient characteristics did not affect the grade ranges of corneal staining in the groups except for level of consciousness. Carbomer eye drops, when used in combination with polyethylene covers, were effective in managing exposure keratopathy. Corneal damage and further ocular complications can be reduced with the utilization of polyethylene covers in nursing care and treatment.

The Effect of Health Belief-Based Education on Physical Activates of Nulliparous Women: A Randomized Control Trial

Background: Regular physical activity during pregnancy is known to have positive effects on the health of the mother and fetus. However, reports indicate that more than half of pregnant women in Iran do not have adequate physical activity. This study was conducted in order to change the behavior of pregnant women in regard to physical activity and also to develop suitable educational/interventional measures. Objectives: This study was conducted to investigate the effects of health belief-based education on the physical activity of nulliparous women. Methods: This triple blinded randomized control trial was conducted among 64 nulliparous women attending the health centers of Ilam, Iran, in 2018. Participants were selected randomly by the cluster sampling method and were allocated to the two groups of control and intervention. Participants in the intervention groups received education and theoretical training based on the health belief model for at least 45 minutes, and then individual practical training was provided. Samples in the control group received routine pregnancy training. Data were collected in two pre-test and post-test stages by a valid questionnaire and were analyzed by SPSS, version 19, using statistical tests, including Chi-square, paired t-test, and independent t-test. Results: The results showed that the levels of perceived sensitivity (-4.750 ± 2.119), (t = 12.215, P ≤ 0.001), perceived severity of threat (-5.312 ± 1.874), (t = -16.036, P &lt; 0.001), perceived benefits (-2.750 ± 1.502), (P &lt; 0.001, t = -10.352), and self-efficacy (-3.656 ± 1.405), (P &lt; 0.001, t = -14.708) in the intervention group significantly increased after the training compared to pre-training. Also, the level of perceived barriers (4.093 ± 1.444), (P &lt; 0.001, t = 16.027) after the training was significantly less than pre-training level. In the intervention group, the total physical activity with the intensity of moderate/severe (2049/000 ± 963.342), (P &lt; 0.001, t = -12.032) was significantly higher than pre-training. Conclusions: The results of this study indicated that training based on the health belief model can increase the physical activity of pregnant women with moderate/severe intensity and bring it to the optimal level of 150 minutes per week by increasing the health beliefs of pregnant women. Therefore, it is suggested that training based on this model should be appropriately incorporated into the routine education of pregnant women.

Role of oral gabapentin in attenuating cardiovascular response to laryngoscopy and tracheal intubation.

Objectives: To determine the role of 800 mg oral gabapentin in attenuating cardiovascular response to laryngoscopy and tracheal intubation. Study Design: Double Blind Randomized Control Trial. Setting: Independent University Hospital/Independent Medical College, Faisalabad, Pakistan. Period: Six months from January1st 2019 to June 30th 2019. Material &amp; Methods: This study included 60 patients which were divided into two equal groups. 800 mg oral gabapentin was given to group I while capsule placebo was administrated to group II patients in pre-operative area one hour prior to surgery. Heart rate, systolic, diastolic and mean arterial blood pressure were taken after induction of anesthesia at base line and then 1,2,3,4,5,10 and 15 minutes after endotracheal intubation. SPSS version 11 was used to analyze the data. Heart rate systolic, diastolic and mean arterial blood pressure were dependent variables while placebo and gabapentin were independent variables. Results: Out of total 60 patients there were 36 (60 %) males and 24 (40 %) females. In group I mean age was 37.1 while in group II it was 36.3. As compare to group II there was decreased cardiovascular response in group I. There was a significant decrease in systolic blood pressure at 1,2 and 10 minutes; diastolic blood pressure at 3 minutes; heart rate at 10 and 15 minutes and mean arterial blood pressure at 3 minutes after induction in group I. Conclusion: Cardiovascular response to laryngoscopy and intubation is significantly reduced with oral gabapentin.

The effects of systemic proteolytic enzyme therapy on pain and swelling in third molar surgery equal to diclofenac therapy: a prospective randomized double blinded clinical trial

The aim of this study was to determine if the timing of administration of systemic enzyme therapy [SET] has any effect on its efficacy in controlling postoperative sequelae of third molar surgery. A double blinded prospective randomized control trial was planned. The sample included patients requiring impacted mandibular third molar surgical extraction. Patients were randomly allocated to four groups (50 patients per group). Group A included administration of SET 48 h prior to surgery; Group B, started on the day of surgery; Group C started immediately after surgery and control group D included NSAIDS started 3 h after surgery. The predictor variable was timing of administration of SET. The primary outcome variables were pain and swelling measured on 1st day, 5th day, and 7th day after surgery. Groups A and D reported lower mean and median VAS scores and lesser swelling than groups C and D on postop day 1. On days 5 and 7, all four groups were comparable. On overall analysis, no statistically significant difference (p > 0.05) was evident. The results of the study showed that the differences in swelling and pain with starting the SET 2 days before, on the day of surgery, or immediately after when compared with diclofenac was not statistically significant. CTRI Registration Number CTRI/2018/03/012502.

Stress ulcer prophylaxis versus placebo\u2014a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD)

BackgroundCritically ill infants with congenital heart disease (CHD) are often prescribed stress ulcer prophylaxis (SUP) to prevent upper gastrointestinal bleeding, despite the low incidence of stress ulcers and limited data on the safety and efficacy of SUP in infants. Recently, SUP has been associated with an increased incidence of hospital-acquired infections, community-acquired pneumonia, and necrotizing enterocolitis. The objective of this pilot study is to investigate the feasibility of performing a randomized controlled trial to assess the safety and efficacy of withholding SUP in infants with congenital heart disease admitted to the cardiac intensive care unit.MethodsA single center, prospective, double-blinded, randomized placebo-controlled pilot feasibility trial will be performed in infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for > 24 h. Patients will be randomized to receive a histamine-2 receptor antagonist (H2RA) or placebo until they are discontinued from respiratory support. Randomization will be performed within 2 strata defined by admission type (medical or surgical) and age (neonate, age < 30 days, or infant, 1 month to 1 year). Allocation will be a 1:1 ratio using permuted blocks to ensure balanced allocations across the two treatment groups within each stratum. The primary outcomes include feasibility of screening, consent, timely allocation of study drug, and protocol adherence. The primary safety outcome is the rate of clinically significant upper gastrointestinal bleeding. The secondary outcomes are the difference in the relative and absolute abundance of the gut microbiota and functional microbial profiles between the two study groups. We plan to enroll 100 patients in this pilot study.DiscussionRoutine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects. The role of SUP in infants with CHD has not been examined, and there is equipoise on the risks and benefits of withholding this therapy. In addition, this therapy has been discontinued in other neonatal populations due to the concern for hospital-acquired infections and necrotizing enterocolitis. Furthermore, exploring changes to the microbiome after exposure to SUP may highlight the mechanisms by which SUP impacts potential microbial dysbiosis of the gut and its association with hospital-acquired infections. Assessment of the feasibility of a trial of withholding SUP in critically ill infants with CHD will facilitate planning of a larger multicenter trial of safety and efficacy of SUP in this vulnerable population.Trial registrationClinicalTrials.gov, NCT03667703. Registered 12 September 2018, https://clinicaltrials.gov/ct2/show/NCT03667703?term=SUPPRESS+CHD&draw=2&rank=1.All WHO Trial Registration Data Set Criteria are met in this manuscript.

Evaluation Of Efficacy Of Chemo-mechanical Method Of Caries Removal Using BRIX- 3000 Compared To Conventional Excavation With Burs- A Randomized Controlled Trial – Original Research

Introduction and Aim The study was designed as a randomized double-blind trial to evaluate the efficacy of chemo-mechanical method of caries removal using BRIX 3000 as compared to conventional excavation with burs. Methods The double blind randomized control trial was performed using a split mouth design where patients with bilateral deep carious lesion underwent treatment with Brix 3000 on one side and high speed bur excavation with aerotar on the contralateral side. This was performed to compare the efficacy of Brix 3000 with the conventional high speed caries excavation using aerotar. Group 1 (G1 = 67 teeth) chemomechanical removal with Brix 3000 and Group 2 (G2= 67 teeth) high speed bur excavation with aerotar. The criteria assessed were the time (T) required for each protocol to be completed and pain perceived by the patient at the end of caries excavation. Results All statistical analysis were done using (SPSS) version 17.0 statistics software. Independent sample t test and Mann Whitney U test were one to analyze the data. Conclusions Though time taken for caries excavation was more using BRIX than the high speed procedures, there was less or no pain while caries excavation using BRIX 3000 along with more patient comfort and cooperation during procedure. From the current study, it was observed that BRIX 3000 can be considered as an effective alternative/adjuvant for caries removal in deep carious lesions as compared to aerosol inducing high speed rotary techniques. Keywords : Chemo-mechanical caries removal, non aerosol inducing caries removal techniques, COVID, BRIX 3000, randomised controlled trial, novel caries removal, dentin preservation.

P0843EFFECT OF GROUP PSYCHO SOCIAL SUPPORT ON QUALITY OF LIFE AND MORTALITY WITH END STAGE KIDNEY DISEASE

Abstract Background and Aims The patients of end stage renal disease suffer a lot of psychological trauma as well as feel a lot of social burden. They mostly show psychological distress in different forms, be it impaired quality of life, depression or anxiety. The aim of our study was to find out the effect of supportive-expressive group therapy in end stage kidney disease patients in the outcome of better health related quality of life and survival. Method 181 patients were recruited in the study after consent between June 2012-June 2017. They were then assigned randomly to Group A supportive-expressive group therapy or to a Group B control group (no intervention). It was a double blinded randomized control trial. 115 patients were assigned to Group A and 66 were assigned to group B. The primary outcome was the effect on health related quality of life. Secondly, if it had any impact on survival. Significant predictors of survival were not analysed. Analysis was done by intention to treat. Results The patients of group A showed decrease in physical pain(p=0.002), mood elevation (p=0.04), compliance with treatment (p=0.001), reduced hopelessness (p=0.004), newly diagnosed depressive disorders (p=0.01) and better social life (p=0.003). Group A had 97% survival rate as compared to group B with 77%. Conclusion Supportive-expressive group therapy to patients with end stage kidney disease improves health related quality of life. It also has an effect on survival maybe because of compliance with treatment. We would like to further explore the role of Supportive-expressive group therapy in survival. Support groups should be provided to patients in developing countries like the setup of ours because it has a great impact on the betterment of the patient.

4439 Comparing the Impact of Adding an Educational Video Presentation to Universal Self-Consent for Remnant Clinical Biospecimens: A Single Blind Randomized-Control Trial

OBJECTIVES/GOALS: BURRITO is an efficient strategy that provides full disclosure in the electronic medical record of a patient’s preference in real time. BURRITO uses printed materials only to inform patients and has a &lt;50% rates of consent. We hypothesized that adding an informational video to the printed materials would increase donations. METHODS/STUDY POPULATION: This study was IRB-approved and was considered minimal risk. The BURRITO self-consent workflow process (Soares et. al, Biopreservation and Biobanking, IN PRINT) was developed in an outpatient cardiology clinic. In the same clinic, patients were randomized to receiving printed materials only (standard procedure) or the printed materials plus a 2.5-minute informational video (intervention) while waiting for the physician in the exam room. Randomization occurred at the level of the day in clinic. Patients were blinded to the nature of the study. Following the presentation of information, the patient’s decision on consent for donation was documented in the electronic record by ancillary clinical staff. Rates of consent were analyzed by a statistician not involved in the experiment and after completion of trial. RESULTS/ANTICIPATED RESULTS: Thirty-five clinic days were randomized to either intervention (17 days) or standard (18 days), and a total of 255 patients decided during their visit to either “opt-in” or “opt-out” to donating remnant biospecimens for future research. One hundred patients opted to defer deciding (28%). No significant demographic differences were noted between the study arms. The rate of consent was 73% vs. 58% in the intervention group and the control group, respectively (p-value = 0.014). This represents an increase in the odds of consenting with an informational video by 96% (OR = 1.96, 95% CI = 1.15 to 3.34). DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first randomized trial to show that an informational video with printed materials is superior for when patients are self-consenting to opt-in for clinical remnant biospecimen donation. This result adds to the evidence that the BURRITO process plus video (BURRITOv) is an effective approach for biospecimen universal consenting.