Use of Lidocaine Cream for Pain Management During Immunizations of Infants at an Urban Health Clinic

2021 ◽  
pp. 089719002110178
Author(s):  
Trisha Lepa ◽  
Menogh Valentine ◽  
Abdullah O. Alshehry ◽  
Eva Paige Morgan ◽  
Kelly Sessa ◽  
...  
Keyword(s):  
Pain Management ◽  
Pediatric Population ◽  
Controlled Trial ◽  
Total Duration ◽  
Standard Of Care ◽  
Health Clinic ◽  
P Value ◽  
Common Source ◽  
Onset Of Action ◽  
To Receive

Background: Immunizations are a common source of pain and anxiety within the pediatric population. Implementation of lidocaine 4% cream, which has a short onset of action, as a standard of care for immunization practices may be feasible. Objective: The objective of this study was to assess the efficacy of lidocaine 4% cream as pain management during immunizations and to evaluate satisfaction of caregivers and nursing staff. Methods: This study was a prospective, randomized, placebo-controlled trial in an urban clinic, which included patients who were ≤ 14 months old accompanied by a caregiver who witnessed the patient receiving an immunization within the previous 7 months. Patients were randomized to receive either lidocaine 4% cream or placebo cream prior to vaccination. Time to cry and duration of cry were recorded. Caregivers completed surveys evaluating attitudes toward pain associated with immunizations as well as their satisfaction with the immunization process through Likert Scale ratings. Nurses completed a questionnaire assessing efficacy and feasibility of lidocaine 4% cream for pain management. Results: A total of 44 patients were included in the analysis in order to achieve 80% power with a p-value < 0.05. Mean duration of cry in patients receiving lidocaine 4% cream was 48.6 seconds in comparison to 65.9 seconds in patients receiving placebo (95%CI, −33.97 seconds to −0.48 seconds; p < 0.05). Conclusions: Lidocaine 4% cream decreased total duration of cry following vaccinations in comparison to placebo with both caregivers and nurses willing to utilize lidocaine 4% cream in a clinic setting if available

Abstract 4776: Prophylactic Intravenous Magnesium Sulphate in Addition to Oral Beta Blockade does not Prevent Atrial Arrhythmias after Cardiac Surgery

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Richard C Cook ◽  
Karin H Humphries ◽  
Ken Gin ◽  
Michael T Janusz ◽  
Victoria Bernstein ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Magnesium Sulphate ◽  
Controlled Trial ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Standard Of Care ◽  
Beta Blockade ◽  
Atrial Arrhythmias ◽  
Hemodynamic Compromise ◽  
To Receive

Background Atrial arrhythmias (AA) affect up to 40% of patients following cardiac surgery. The best strategy for prevention of AA remains undetermined, however, beta blocker (BB) administration is the standard of care at many centers (including ours). Although there is now compelling evidence demonstrating the utility of magnesium sulphate (MgSO4) for treatment of AA, the effectiveness of MgSO4 for prophylaxis of AA remains controversial. This study is the largest randomized, placebo-controlled trial of intravenous (IV) MgSO4 for the prevention of AA following cardiac surgery. Methods Eligible patients requiring either coronary artery bypass graft surgery (CABG), or valve surgery ± CABG, were randomized to receive either 5g IV MgSO4, or placebo upon removal of the crossclamp, followed by daily infusions of IV MgSO4 or placebo over 4 hours, from the day of surgery until post-operative day 4. All patients were treated according to an established protocol with oral BB (atenolol). Patients were monitored by continuous telemetry for the first 5 post-operative days. The primary endpoint was an AA lasting ≥ 30 minutes, or requiring treatment because of hemodynamic compromise. Results Table 1 summarizes the results. There was no difference in the incidence of AA between patients who received IV MgSO4 or those who received placebo. Conclusions In patients proactively treated with atenolol using an established protocol, the addition of daily IV MgSO4 infusions for 5 days post-operatively did not reduce the incidence of clinically important AA following cardiac surgery. Results For Primary Outcome (Post-Operative AA)

O3 DIRECT ORAL FEEDING FOLLOWING MINIMALLY INVASIVE ESOPHAGECTOMY (NUTRIENT II TRIAL): AN INTERNATIONAL, MULTICENTER, OPEN-LABEL RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Gijs H K Berkelmans ◽  
Laura F C Fransen ◽  
Annemarie C P Dolmans-Zwartjes ◽  
Ewout A Kouwenhoven ◽  
Marc J van Det ◽  
...  
Keyword(s):  
Anastomotic Leakage ◽  
Functional Recovery ◽  
Controlled Trial ◽  
Minimally Invasive Esophagectomy ◽  
Standard Of Care ◽  
Oral Feeding ◽  
Control Group ◽  
P Value ◽  
Invasive Esophagectomy ◽  
And Control

Abstract Aim Patients undergoing an esophagectomy are often kept nil-by-mouth postoperatively out of fear for increasing anastomotic leakage and pulmonary complications. This study investigates the effect of direct start of oral feeding following minimally invasive esophagectomy (MIE) compared to standard of care. Background & Methods Elements of enhanced recovery after surgery (ERAS) protocols have been successfully introduced in patients undergoing an esophagectomy. However, start of oral intake, which is an essential part of the ERAS protocols, remains a matter of debate. Patients in this multicenter, international randomized controlled trial were randomized to directly start oral feeding (intervention) after a MIE with intrathoracic anastomosis or to receive nil-by-mouth and tube feeding for five days postoperative (control group). Primary outcome was time to functional recovery. Secondary outcome parameters included anastomotic leakage, pneumonia rate and other surgical complications scored by predefined definitions. Results Baseline characteristics were similar in the intervention (n=65) and control (n=67) group. Functional recovery was seven days for patients receiving direct oral feeding compared to eight days in the control group (p-value 0.436). Anastomotic leakage rate did not differ in the intervention (18.5%) and control group (16.4%, p-value 0.757). Pneumonia rates were comparable between the intervention (24.6%) and control group (34.3%, p-value 0.221). Other morbidity rates were similar, except for chyle leakage which was more prevalent in the standard of care group (p-value 0.032). Conclusions Direct oral feeding after an esophagectomy does not affect functional recovery and did not increase incidence or severity of postoperative complications.

scholarly journals Effect of preoperative information about pain on postoperative pain experience and patient satisfaction following orthopaedic surgery: A randomised controlled trial.

2020 ◽  
Author(s):  
Moses Othin ◽  
Cornelius Sendagire ◽  
John Mukisa ◽  
Clare Lubulwa ◽  
Phillip Mulepo ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Pain Management ◽  
Postoperative Pain ◽  
Pain Score ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
P Value ◽  
Pain Experience ◽  
Significant Difference ◽  
Preoperative Information

Abstract Background: Preoperative information about pain has been shown to improve postoperative pain perception and reduce postoperative analgesia requirements. However, there is limited data regarding the effect of preoperative counselling in low resource settings. This study aimed at assessing the effect of preoperative information about pain on postoperative pain experience measured as postoperative pain using a verbal numerical rating scale (VNRS) and patient satisfaction with pain management. Methods: A randomised, double blind, controlled trial was done in Mulago National Referral Hospital (MNRH), Kampala. We prospectively enrolled 400 participants aged 18years and above scheduled for elective orthopaedic surgery. The consented patients were randomised to either receive the specific preoperative information about pain or not. The primary end points were postoperative pain score and patient satisfaction. A total of 340 were analysed with 170 in either arm. Secondary analyses where done to determine the factors that were associated with postoperative pain and patient satisfaction.Results: In both arms, the lowest pain score was 0/10 at 0 hours and the highest was 7/10 at 12 hours. A statistically significant difference between the intervention and control arms for the median pain score at 48hours (4/10 vs. 5/10) P-value= 0.029 was seen but none at 0, 12, 24hours. There was no difference in satisfaction with pain management (P value=0.059). Conclusion: Preoperative information about pain improves postoperative pain experience and may negatively impact patients’ satisfaction with pain management due to unmet expectations.Trial registration: Clinicaltrials.gov, NCT03056521. Registered 17 February 2017 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03056521

scholarly journals SAT-LB18 A Randomized Controlled Trial of Vosoritide in Children With Achondroplasia

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Ravi Savarirayan ◽  
Louise Tofts ◽  
Melita Irving ◽  
William Wilcox ◽  
Carlos A Bacino ◽  
...  
Keyword(s):  
Growth Velocity ◽  
Controlled Trial ◽  
Subcutaneous Administration ◽  
Growth Factor Receptor ◽  
P Value ◽  
Primary Analysis ◽  
Open Label ◽  
Gene Encoding ◽  
Double Blind ◽  
To Receive

Abstract Background: Achondroplasia is a disorder caused by specific mutations in the gene encoding the fibroblast growth factor receptor 3 (FGFR3) protein. Open-label, phase 2 trials in children with achondroplasia showed that administration of vosoritide, an analogue of C-natriuretic peptide, resulted in sustained increases in annualized growth velocity. Methods: This international, randomized, double-blind, phase 3 trial compared once-daily subcutaneous administration of vosoritide, at a dose of 15 μg per kg of body weight, with placebo in children with achondroplasia aged 5 to &lt;18 years. Eligible patients had participated, for at least 6 months, in an observational growth study in order to calculate their baseline annualized growth velocity. The primary efficacy endpoint was the change from baseline in annualized growth velocity at week 52 of treatment. The primary analysis of the change from baseline in annualized growth velocity was performed using an ANCOVA model. Results: A total of 121 patients were randomized, with 60 assigned to receive vosoritide and 61 to receive placebo. A total of 119 patients completed the 52-week trial. The adjusted mean difference in annualized growth velocity between patients administered vosoritide and those administered placebo was 1.57 cm per year in favor of vosoritide (95% CI: [1.22, 1.93], two-sided p-value &lt;0.001). A total of 119 patients experienced at least one adverse event (vosoritide group, 59 [98.3%], placebo group, 60 [98.4%]). Conclusions: Daily, subcutaneous administration of vosoritide to children with achondroplasia resulted in a significant increase in mean annualized growth velocity and similar incidence of adverse events compared to placebo.

scholarly journals Efficacy of a nurse-led lipid-lowering secondary prevention intervention in patients hospitalized for ischemic heart disease: A pilot randomized controlled trial

2019 ◽  
Vol 18 (5) ◽  
pp. 366-374
Author(s):  
Sonia Ruiz-Bustillo ◽  
Consol Ivern ◽  
Neus Badosa ◽  
Nuria Farre ◽  
Esther Marco ◽  
...  
Keyword(s):  
Heart Disease ◽  
Ischaemic Heart Disease ◽  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Lipid Level ◽  
Standard Of Care ◽  
Lipid Lowering ◽  
P Value ◽  
Cholesterol Levels

Background and aims: Lack of achievement of secondary prevention objectives in patients with ischaemic heart disease remains an unmet need in this patient population. We aimed at evaluating the six-month efficacy of an intensive lipid-lowering intervention, coordinated by nurses and implemented after hospital discharge, in patients hospitalized for an ischaemic heart disease event. Methods: Randomized controlled trial, in which a nurse-led intervention including periodic follow-up, serial lipid level controls, and subsequent optimization of lipid-lowering therapy, if appropriate, was compared with standard of care alone in terms of serum lipid-level control at six months after discharge. Results: The nurse-led intervention was associated with an improved management of low-density lipoprotein (LDL) cholesterol levels compared with standard of care alone: LDL cholesterol levels ⩽100 mg/dL were achieved in 97% participants in the intervention arm as compared with 67% in the usual care arm ( p value <0.001), the LDL cholesterol ⩽70 mg/dL target recommended by the 2016 European Society of Cardiology guidelines was achieved in 62% vs. 37% participants ( p value 0.047) and the LDL cholesterol reduction of ⩾50% recommended by the American College of Cardiology/American Heart Association in 2013 was achieved in 25.6% of participants in the intervention arm as compared with 2.6% in the usual care arm ( p value 0.007). The intervention was also associated with improved blood pressure control among individuals with hypertension. Conclusions: Our findings highlight the opportunity that nurse-led, intensive, post-discharge follow-up plans may represent for achieving LDL cholesterol guideline-recommended management objectives in patients with ischaemic heart disease. These findings should be replicated in larger cohorts.

scholarly journals Efficacy and Safety of Leflunomide for Refractory COVID-19: A Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Qiang Wang ◽  
Haipeng Guo ◽  
Yu Li ◽  
Xiangdong Jian ◽  
Xinguo Hou ◽  
...  
Keyword(s):  
Pilot Study ◽  
Clearance Rate ◽  
Standard Care ◽  
Discharge Rate ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Large Sample Size ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
To Receive

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may persist in patients with coronavirus disease 2019 (COVID-19) despite receiving standard care.Methods: In this pilot study of hospitalized adult patients (≥18 years of age), with radiologically confirmed pneumonia who were SARS-CoV-2 positive for more than 28 days despite standard care, were assigned to receive standard of care (SOC, grp I) or leflunomide + SOC (grp 2). After 2 weeks, grp 1 and grp 2 patients who continued to be SARS-CoV-2-positive received leflunomide for 14 days while continuing SOC. The primary outcomes were the rate of and time to SARS-CoV-2 clearance and the 14-day and 30-day hospital discharge rate.Results: 12 patients were enrolled in grp 1 and 15 patients were in grp 2. The 14 days SARS-CoV-2 viral clearance rate was 80.0% (12/15) for grp 2 patients receiving leflunomide vs. 16.7% for grp 1 patients (2/12) (p = 0.002). By day 14, the median time to SARS-CoV-2 clearance was 6.0 days (range 1–12, IQR 1–12) for grp 2 patients. In grp 1, two patients converted to viral negative on days 1 and 6 (p = 0.002). The 14-day discharge rate was 73.3% (11/15) for the grp 2 vs. 8.3% (1/12) for grp 1 (p = 0.001). The 30 days discharge rate was 100% (15/15) for the grp 2 vs. 66.7% (8/12) for grp 1. No severe adverse events or deaths were reported.Conclusion: Leflunomide may improve the SARS-CoV-2 clearance rate and discharge rate in patients with refractory COVID-19. The tolerability of the 14–28 days course of treatment with leflunomide is acceptable. These preliminary observations need to be verified by a large sample size and randomized controlled trial.

scholarly journals Fostamatinib for the treatment of hospitalized adults with COVD-19 A randomized trial

2021 ◽  
Author(s):  
Jeffrey R Strich ◽  
Xin Tian ◽  
Mohamed Samour ◽  
Christopher S King ◽  
Oksana Shlobin ◽  
...  
Keyword(s):  
Immune Response ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Reactive Protein ◽  
To Receive ◽  
Confirmatory Trials

Abstract Background Coronavirus Disease 2019 (Covid-19) requiring hospitalization is characterized by robust antibody production, dysregulated immune response and immunothrombosis. Fostamatinib, is a novel spleen tyrosine kinase inhibitor we hypothesize will ameliorate Fc activation and attenuate harmful effects of the anti-COVID-19 immune response. Methods We conducted a double-blind, randomized, placebo-controlled trial in hospitalized adults requiring oxygen with Covid-19 where patients receiving standard of care were randomized to receive fostamatinib or placebo. The primary outcome was serious adverse events by day 29. Results A total of 59 patients underwent randomization (30 to fostamatinib and 29 to placebo). Serious adverse events occurred in 10.5% of patients in the fostamatinib group compared to 22% in placebo (P = .2). Three deaths occurred by day 29, all receiving placebo. The mean change in ordinal score at day 15 was greater in the fostamatinib group (-3.6 ± 0.3 vs. -2.6 ± 0.4, P = .035) and the median length in the ICU was 3 days in the fostamatinib group vs. 7 days in placebo (P = .07). Differences in clinical improvement were most evident in patients with severe or critical disease (median days on oxygen, 10 vs. 28, P = .027). There were trends towards more rapid reductions in C-reactive protein, D-dimer, fibrinogen and ferritin levels in the fostamatinib group. Conclusion For COVID-19 requiring hospitalization, the addition of fostamatinib to standard of care was safe and patients were observed to have improved clinical outcomes compared to placebo. These results warrant further validation in larger confirmatory trials.

scholarly journals Comparative study of midline versus paramedian approach of spinal block in elderly.

2021 ◽  
Vol 28 (11) ◽  
pp. 1664-1667
Author(s):  
Nadia Bano ◽  
Nazim Hayat ◽  
Saira Saleem ◽  
Ayesha Rehman ◽  
Farhan Javed ◽  
...  
Keyword(s):  
Success Rate ◽  
Controlled Trial ◽  
Spinal Block ◽  
P Value ◽  
Group A ◽  
Group B ◽  
Midline Approach ◽  
To Receive ◽  
Method Group ◽  
Trial Setting

Objective: To compare the efficacy of paramedian and midline approach for spinal block in elderly, in terms of success rate and number of attempts required by either approach. Study Design: Randomized Controlled Trial. Setting: Department of Anaesthesia, Madina Teaching Hospital Faisalabad. Period: January 2018 to December 2019. Material & Method: 120 elderly ASA I-III patients scheduled to undergo lower abdominal or limbs; general or orthopaedic surgery were randomly divided into two equal groups A and B of sixty patients. Patients were assigned into groups by lottery method. Group A patients were supposed to receive spinal block by midline approach while group B patients were planned to receive spinal block by paramedian approach. Results: It was observed that success rate was significantly high in group B, 98.3% as compared to group A, 80%, (p value 0.001). The number of attempts were significantly less in group B in comparison to group A (p-value 0.0001). Conclusion: The paramedian approach for spinal block in elderly patient’s offers ease of administration and a higher success rate as compared to midline approach.

Overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial.

2019 ◽  
Vol 37 (18_suppl) ◽  
pp. LBA2-LBA2 ◽  
Author(s):  
Christopher Sweeney ◽  
Andrew James Martin ◽  
Robert Richard Zielinski ◽  
Alastair Thomson ◽  
Thean Hsiang Tan ◽  
...  
Keyword(s):  
Overall Survival ◽  
A Priori ◽  
Standard Of Care ◽  
Phase Iii ◽  
P Value ◽  
Serious Adverse Events ◽  
Treatment Groups ◽  
Hormone Sensitive ◽  
To Receive

LBA2 Background: Testosterone suppression (TS) is the backbone of treatment for mHSPC. OS is improved by the addition of early docetaxel (DOC) or abiraterone to TS. ENZAMET assessed the effects of enzalutamide (ENZA), a potent androgen receptor (AR) inhibitor, versus a nonsteroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide) in addition to SOC (TS with or without DOC) in mHSPC. Methods: Men with mHSPC were randomly assigned 1:1 to receive TS plus either ENZA or NSAA. Randomization was stratified by: volume of disease (high vs low, according to CHAARTED); planned early DOC; planned anti-resorptive therapy, comorbidity score (ACE-27), and study site. The primary endpoint was overall survival. Accrual of 1100 men provided 80% power to detect a 25% reduction in the hazard of death (HR 0.75) with up to 4 interim analyses (IA), the first planned to occur after 235 deaths (50% of total information with a critical p-value threshold <0.0031 by the Lan-DeMets alpha-spending approach with O’Brien-Fleming type shape). Subgroup analyses to assess possible modulation of the treatment effect were specified a priori and included planned early docetaxel (yes vs no) and volume of disease (high vs low). Results: We randomly assigned 1125 patients from 31MAR14 to 24MAR17. The treatment groups were well balanced for all important baseline factors. Criteria for early reporting were met at the first IA (28FEB2019) after a median follow-up of 33 months. Overall survival was prolonged by ENZA (see below). At 3 years, 36% NSAA vs 64% ENZA were still on their assigned study treatment. Serious adverse events (regardless of attribution) within 30 days of study treatment occurred in 42% ENZA vs 34% NSAA, commensurate with the different durations of study treatment. Conclusions: ENZA significantly improved OS when added to SOC in mHSPC. The benefits appeared lower in those planned to receive early DOC. Results of analyses with updated follow-up triggered by this IA will be presented. Clinical trial information: NCT02446405. [Table: see text]

scholarly journals Role of single and mixed probiotics in acute diarrheal diseases in pediatric population

2017 ◽  
Vol 6 (11) ◽  
pp. 2596
Author(s):  
Ambrish Gupta ◽  
Prashant Maheshwari ◽  
Y. K. Rao
Keyword(s):  
Pediatric Population ◽  
Controlled Trial ◽  
Total Duration ◽  
Diarrhoeal Disease ◽  
Control Group ◽  
Double Blind ◽  
Medical College ◽  
Significant Difference ◽  
Probiotic Preparation ◽  
Diarrhoeal Diseases

Background: The objective of present study was to analyse the effect of probiotics on various parameters of acute diarrhoeal disease and to compare single and mixed probiotic preparations in context to their role in acute diarrhoeal disease in paediatric population.Methods: A double blind controlled trial was conducted in children suffering from acute diarrhoeal disease at department of paediatrics jointly with department of pharmacology, G. S. V. M. Medical college, Kanpur, U.P., India. All enrolled children were divided into three groups having similar baseline characteristics. One group was given single probiotic preparation another mixed probiotic preparation and the third one (i.e. control group) placebo plus Zinc/ORS to all three groups. Various parameters such as frequency and consistency of stool, duration of diarrhoea were measured after doing intervention over a period of one week.Results: In our study duration of diarrhoea, stool frequency and total duration of hospital stay was found significantly less in probiotic groups compared to control group. However no significant difference was found between single and mixed probiotics in curtailing the acute diarrhoeal illness.Conclusions: Probiotics should be used judiciously in acute diarrhoeal diseases. There is no additional benefit of mixed probiotics in acute diarrhoeal diseases rather than increasing the cost of treatment.

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