scholarly journals Normal saline flushes performed once daily maintain peripheral intravenous catheter patency: a randomised controlled trial

2015 ◽  
Vol 100 (7) ◽  
pp. 700-703 ◽  
Author(s):  
Silvana Schreiber ◽  
Chiara Zanchi ◽  
Luca Ronfani ◽  
Anna Delise ◽  
Alessandra Corbelli ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Normal Saline ◽  
Controlled Trial ◽  
Nursing Time ◽  
Catheter Patency ◽  
Registration Number ◽  
Peripheral Intravenous Catheter ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

ObjectiveRecent evidence supports the use of normal saline flushes in place of heparin to maintain the patency of peripheral intravenous locks (IVLs); however, there are no data regarding the recommended flush frequency.Study designThis was an open, non-inferiority, randomised controlled trial. Children with IVLs, aged 1–17 years, were randomly assigned to receive saline flushing every 12 h (group A) or every 24 h (group B). The main outcome was the maintenance of catheter patency.ResultsFour hundred patients were randomised; 198 subjects were analysed in the 12 h group and 199 in the 24 h group (three patients were lost at follow-up). Occlusion occurred in 15 children (7.6%) in group A versus 9 (4.5%) in group B (p=0.21). The difference in catheter patency was +3.1% in favour of the 24 h group (95% CI −1.6% to 7.7%), showing the non-inferiority of the 24 h procedure (the non-inferiority margin was set at −4%). Catheter-related complications were not different between the two groups (12.1% in group A vs 9.5% in group B; p=0.42).ConclusionsA flushing procedure with one flush per day allows maintenance of catheter patency without an increase in catheter-related complications. We propose a simplification of the flushing procedure with only one flush per day, thereby reducing costs (materials use and nursing time), labour and unnecessary manipulation of the catheters which can cause distress in younger children and their parents.Trial registration numberThe study is registered in the international database ClinicalTrial.gov under registration number NCT02221024.

scholarly journals Dexmedetomidine and Fentanyl for Postoperative Analgesia in Patients Undergoing Abdominal Surgery: Randomised Controlled Trial

2021 ◽  
Author(s):  
Prashant Sachan ◽  
Prem Raj Singh ◽  
Sateesh Verma ◽  
Brij Bihari Kushwaha
Keyword(s):  
Postoperative Pain ◽  
Randomised Controlled Trial ◽  
Abdominal Surgery ◽  
Postoperative Analgesia ◽  
Pain Control ◽  
Controlled Trial ◽  
Haemodynamic Stability ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

Introduction: Pain control is an important factor for postoperative recovery. Many drugs have been studied for effectiveness of postoperative analgesia. Fentanyl is a conventional drug and dexmedetomidine is one of the emerging drugs used for analgesia and postoperative pain control. Aim: To compare the effect of fentanyl and dexmedetomidine on pain control and haemodynamic stability. Materials and Methods: A randomised controlled trial was conducted on 60 patients (30 each group) undergoing for abdominal surgery, between January 2019 to January 2020. Group A received fentanyl loading dose 2 μg/kg I.V. followed by 0.5 μg/kg/hr infusion and group B received dexmedetomidine loading 1 μg/kg over 10 minutes followed by maintenance 0.5 μg/kg/hr infusion. Infusion was continued up to four hours during surgery and till eight hours of postoperative in both groups. Haemodynamic parameters {Heart Rate (HR), Mean Arterial Pressure (MAP)} were recorded after start of study drug infusion, after intubation, then every 15 minutes till 1 hour, then every 30 minutes till end of surgery and after extubation. In postoperative period, HR and MAP were recorded at interval of one hour till eight hours after extubation and postoperative analgesia was assessed by Visual Analogue Scale (VAS) at interval of one hour till eight hours. Present study used descriptive statistical analysis for data analysis. Analysis of variance (ANOVA) was used to compare data between two groups. Chi-square test was used to find the significance of difference on categorical scale between two groups. Results: This study showed that group-B had significantly less VAS score most of time in recovery period as compared to group-A (1.97±0.18 vs 2.10±0.31 at eight hours postoperative). HR, MAP was found significantly less all the time during surgery and most of the time postoperatively in group-B (p-value <0.05). Conclusion: Intravenous infusion of dexmedetomidine can be better for controlling postoperative pain and perioperative haemodynamic stability as compared to infusion of fentanyl in patients undergoing abdominal surgeries.

scholarly journals Role of Saccharomyces boulardii and Bacillus clausii in reducing the duration of diarrhea: a three-armed randomised controlled trial

2018 ◽  
Vol 5 (5) ◽  
pp. 1811 ◽  
Author(s):  
Vidjeadevan D. ◽  
Vinoth S. ◽  
Ramesh S.
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Saccharomyces Boulardii ◽  
Major Public Health Problem ◽  
Duration Of Stay ◽  
Bacillus Clausii ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

Background: Diarrhea is a major public health problem. Probiotics have been recommended as an add-on therapy for the treatment of diarrhea. Recently Saccharomyces boulardii and Bacillus clausii, yeast and spore forming bacilli are among the probiotics in use for diarrheal disorder.Methods: This was a three armed randomised controlled trial conducted in pediatrics department, in a tertiary level care at Chidambaram. The randomisation was done using permuted blocks method. Of the three groups, Group A received ORS and zinc; Group B ORS, zinc and S. boulardii and Group C ORS, zinc and B. clausii. The outcome variables included duration of diarrhea and duration of stay in hospital.Results: The duration of diarrhea decreased significantly in Group B and C than Group A. Both the probiotics had similar effect in reducing the duration of diarrhea. There was no significant difference in duration of stay at hospital between the groups.Conclusions: Addition of probiotics as an add-on therapy would aid in decreasing the duration of diarrhea rather than giving ORS and zinc alone. The duration of stay in hospital was unaffected by the change in regimen of treatment.

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

scholarly journals Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044045
Author(s):  
Ben Colagiuri ◽  
Louise Sharpe ◽  
Zahava Ambarchi ◽  
Nick Glozier ◽  
Delwyn Bartlett ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Treatment Period ◽  
Controlled Trial ◽  
Severity Index ◽  
Open Label ◽  
Human Research Ethics ◽  
Sleep Parameters ◽  
Registration Number ◽  
Randomised Controlled ◽  
Insomnia Symptoms

IntroductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.Methods and analysisThis study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.Ethics and disseminationThe trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.Trial registration numberACTRN12620001080910.

scholarly journals A randomised controlled trial on roles of prostaglandin E1 nebulization among patients undergoing one lung ventilation

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Pengyi Li ◽  
Lianbing Gu ◽  
Jing Tan ◽  
Zhenghuan Song ◽  
Qingming Bian ◽  
...  
Keyword(s):  
Prostaglandin E1 ◽  
Controlled Trial ◽  
Lung Ventilation ◽  
Inflammatory Factors ◽  
Pulmonary Shunt ◽  
One Lung Ventilation ◽  
Reference Concentration ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

Abstract Background Prostaglandin E1 (PGE1) has been reported to maintain adequate oxygenation among patients under 60% FiO2 one-lung ventilation (OLV). This research aimed to explore whether PGE1 is safe in pulmonary shunt and oxygenation under 40% FiO2 OLV and provide a reference concentration of PGE1. Methods Totally 90 esophageal cancer patients treated with thoracotomy were enrolled in this study, randomly divided into three groups (n = 30/group): Group A (60% FiO2 and 0.1 µg/kg PGE1), Group B (40% FiO2 and 0.1 µg/kg PGE1), and Group C (40% FiO2, 0.2 µg/kg PGE1). Primary outcomes were oxygenation and pulmonary shunt during OLV. Secondary outcomes included oxidative stress after OLV. Results During OLV, patients in Group C and B had lower levels of PaO2, SaO2, SpO2, MAP, and Qs/Qt than those in Group A (P < 0.05). At T2 (OLV 10 min), patients in Group C and B exhibited a lower level of PaO2/FiO2 than those in Group A, without any statistical difference at other time points. The IL-6 levels of patients in different groups were different at T8 (F = 3.431, P = 0.038), with IL-6 in Group C being lower than that in Group B and A. MDA levels among the three groups differed at T5 (F = 4.692, P = 0.012) and T7 (F = 5.906, P = 0.004), with the MDA level of Group C being lower than that of Group B and A at T5, and the MDA level of Group C and B being lower than that of Group A at T7. In terms of TNF-α level, patients in Group C had a lower level than those in Group B and A at T8 (F = 3.598, P = 0.033). Compared with patients who did not use PGE1, patients in Group C had comparable complications and lung infection scores. Conclusion The concentration of FiO2 could be reduced from 60 to 40% to maintain oxygenation. 40% FiO2 + 0.2 µg/kg PGE1 is recommended as a better combination on account of its effects on the inflammatory factors. Trial registration: Chictr.org.cn identifier: ChiCTR1800018288, 09/09/2018.

scholarly journals Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

2021 ◽  
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Well Being ◽  
Likert Scale ◽  
Control Group ◽  
Group A ◽  
Measuring Scale ◽  
Group B ◽  
Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

scholarly journals Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e033150 ◽  
Author(s):  
Flavia K Borges ◽  
P J Devereaux ◽  
Meaghan Cuerden ◽  
Mohit Bhandari ◽  
Ernesto Guerra-Farfán ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Surgical Treatment ◽  
Hip Fracture ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Surgery

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial

2020 ◽  
Vol 19 (6) ◽  
pp. 529-536
Author(s):  
Camilla Wistrand ◽  
Ulrica Nilsson ◽  
Ann-Sofie Sundqvist
Keyword(s):  
Randomised Controlled Trial ◽  
Patient Experience ◽  
Room Temperature ◽  
Controlled Trial ◽  
Cardiac Device ◽  
Negative Experience ◽  
Device Implantation ◽  
Skin Disinfection ◽  
Registration Number ◽  
Randomised Controlled

Background: Clinically, patients often comment on the coolness of the skin disinfectant. However, scarce evidence is available regarding patients’ experience during intraoperative skin disinfection. Aims: The aim of this study was to describe and compare intraoperative patient experiences with preheated and room temperature skin disinfectant. Method: This randomised controlled trial included 220 patients undergoing cardiac device implantation. Patients allocated to preheated (36°C) or room temperature (20°C) chlorhexidine in 70% ethanol verbally answered an open-ended question regarding their experience with the skin disinfection. Results were assessed using a qualitative approach with comparative quantification. Results: The analysis resulted in nine categories describing the patients’ experiences with preheated and room temperature skin disinfection. Most of the patients described the skin disinfection process as a negative experience, which consisted of six categories: cold, smell, change in temperature, unpleasant, wet and painful. In addition, two neutral categories of response (nothing in particular and neither pleasant nor unpleasant) and one positive response (pleasant) emerged through the analysis. Preheated skin disinfection yielded significantly fewer negative experiences in the category cold (85% vs. 15%, P<0.0001) and significantly more positive experiences (66% vs. 34%, P<0.002). Neutral categories (neither pleasant nor unpleasant 65% vs. 35%, P=0.01, nothing in particular 74% vs. 26%, P<0.001) dominated after preheated skin disinfection. Conclusion: The use of preheated skin disinfection promotes a positive patient experience with skin disinfection. Trial registration: ClinicalTrials.gov registration number NCT02260479 ( https://clinicaltrials.gov/ct2/results?cond=preheated+skin+disinfection ).

scholarly journals Examining the effects of enhanced provider–patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015505 ◽  
Author(s):  
Liesbeth M van Vliet ◽  
Sandra van Dulmen ◽  
Bram Thiel ◽  
Gerard W van Deelen ◽  
Stephanie Immerzeel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Clinical Care ◽  
Numeric Rating Scale ◽  
Study Results ◽  
Audio Recordings ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Ward

IntroductionPlacebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider’s communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients’ outcomes.Methods and analysisUsing a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse–patient interactions.Ethics and disseminationAlthough communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication.Trial registration numberNTR5994; Pre-results.

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