scholarly journals Effects of an individualized analgesia protocol on the need for medical interventions after adenotonsillectomy in children: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jian Guo ◽  
Peijun Zhuang ◽  
Kun Liu ◽  
Yuanyuan Wan ◽  
Xuan Wang
Keyword(s):  
Median Duration ◽  
Controlled Trial ◽  
Pain Scale ◽  
Medical Intervention ◽  
Secondary Outcome ◽  
Sleep Study ◽  
Medical Interventions ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Blinded Trial

Abstract Background It has been proposed that the dose of rescue opioids should be individually titrated to the severity of obstructive sleep apnea after adenotonsillectomy. However, a sleep study is not always available before adenotonsillectomy. This randomized, controlled and blinded trial evaluated a strategy of pain control individualized to the results of a fentanyl test, rather than the results of polysomnography, in children after adenotonsillectomy. Methods A total of 280 children (3–10 years old) undergoing elective adenotonsillectomy were randomized into an individualized protocol (IP) group or a conservative protocol (CP) group. All patients received a fentanyl test before extubation. Pain was assessed every 10 min in the recovery room, and rescue morphine was given when the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) score was > 6. In the IP group, the dose of rescue morphine was individualized to the results of the fentanyl test (10 μg/kg in the case of a positive result and 50 μg/kg in the case of a negative result). In the CP group, the dose was fixed (25 μg/kg). The primary outcome was the percentage of patients requiring at least one medical intervention. The secondary outcome was the median duration of CHEOPS scores > 6. Results Fewer patients in the IP group than in the CP group required medical interventions [11.9% (16/134) vs 22.3% (29/130), P = 0.025]. The median duration of CHEOPS scores > 6 was shorter in the IP group than in the CP group [20 (95% CI: 17 to 23) min vs 30 (95% CI: 28 to 32) min, P <  0.001]. Conclusions Compared with a conservative dosing approach, this individualized protocol may improve analgesia without a significant increase in respiratory adverse events. Trial registration ClinicalTrials.gov NCT02990910, registered on 13/12/2016.

SIESTA - Home sleep study with BresoDx for obstructive sleep apnea: a randomized controlled trial

2020 ◽  
Vol 65 ◽  
pp. 45-53
Author(s):  
Michael Fitzpatrick ◽  
Valeria E. Rac ◽  
Nicholas Mitsakakis ◽  
Lusine Abrahamyan ◽  
Petros Pechlivanoglou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Controlled Trial ◽  
Sleep Study ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Home Sleep Study

scholarly journals Postoperative Pain and 14-Day Recovery in Children Undergoing Adenotonsillectomy: Low Thermal Damage Device Versus Electrosurgery

2019 ◽  
Vol 98 (4) ◽  
pp. E1-E7 ◽  
Author(s):  
Kathryn V. Blake ◽  
Jobayer Hossain ◽  
Brett Chafin ◽  
Angela Black ◽  
Stefanie Schrum ◽  
...  
Keyword(s):  
Sleep Disordered Breathing ◽  
Thermal Damage ◽  
Controlled Trial ◽  
Median Number ◽  
Pain Scale ◽  
Pain Medication ◽  
Adenotonsillar Hypertrophy ◽  
Randomized Controlled ◽  
Pain Scores ◽  
Obstructive Sleep

This was a randomized controlled trial of low thermal damage device versus traditional electrosurgery in children 3 to 17 years old with a clinical diagnosis of sleep disordered breathing, obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis. Pain score (Wong-Baker FACES pain scale) was recorded each morning before eating, drinking, or administering pain medication for 14 days postoperatively. Seventy-five children were enrolled. There was no difference in the rate of decrease in pain scores. A significant interaction between rate of pain decrease and number of pain medication doses was present ( P < .0001). Median number of pain medication doses was greater with electrosurgery (36, range: 7-49) versus low thermal device (21, range: 2-124; P = .001). Pain scores reached 0 after a median of 7 days (95% confidence interval [CI], 5.2-8.6) for low thermal device and 9 days (95% CI, 8.0-10.0) for electrosurgery ( P = .67). One child randomized to electrosurgery was withdrawn due to hospitalization for postoperative bleed. In children, low thermal device results in significantly less pain medication used during the postoperative period than electrosurgery.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Disability ◽  
Inflammatory Arthritis ◽  
Missing Values ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Serum Uric Acid Level ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
To Receive ◽  
Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

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