scholarly journals Insulin syringe for anaesthetic injection in ptosis surgery: A randomised controlled clinical study

2021 ◽  
Author(s):  
Won Seok Song ◽  
Min Joung Lee ◽  
Youn Joo Choi
Keyword(s):  
Local Anaesthesia ◽  
Skin Incision ◽  
Controlled Study ◽  
Injection Pain ◽  
Eyelid Oedema ◽  
Registration Number ◽  
Unbearable Pain ◽  
Randomised Controlled ◽  
Controlled Clinical Study ◽  
Ptosis Surgery

Abstract Background: To evaluate the potential benefit of using insulin syringes for local anaesthesia in ptosis surgery.Methods: Sixty patients (120 eyelids) were included in this randomised, fellow eye-controlled study at a university‐based hospital. An insulin syringe was used on one eyelid and a conventional 30-gauge needle on the other. Patients were asked to score pain in both eyelids using a visual analogue scale (VAS) ranging from 0 (no pain at all) to 10 (unbearable pain). Ten minutes after the injection, an observer scored the degree of haemorrhage and oedema in both eyelids on a scale of 0 to 4.Results: The VAS score was 5.17 in the insulin syringe group and 5.35 in the 30-gauge needle group (p=0.264). Ten minutes after the anaesthesia, the haemorrhage score was 1.30 and 1.64 and eyelid oedema score was 1.50 and 1.80 in the insulin syringe and 30-gauge needle groups, respectively (haemorrhage, p=0.045; eyelid oedema, p=0.023). Conclusion: Injecting local anaesthesia using an insulin syringe, compared to conventional 30-gauge needles, significantly reduces haemorrhage and eyelid oedema before skin incision but does not significantly reduce the injection pain. Using insulin syringes also presents fewer complications related to tissue penetration and lesser distortion of anatomical structures compared to conventional 30-gauge needles. We recommend using an insulin syringe for local anaesthesia in ptosis surgery.Trial registration: registry – CRIS / registration number – KCT0005120 / date of registration: 12/06/2020 (retrospectively registered), https://cris.nih.go.kr/cris/index.jsp

scholarly journals Thermoregulatory effects of swaddling in Mongolia: a randomised controlled study

2015 ◽  
Vol 101 (2) ◽  
pp. 152-160 ◽  
Author(s):  
Bazarragchaa Tsogt ◽  
Semira Manaseki-Holland ◽  
Jon Pollock ◽  
Peter S Blair ◽  
Peter Fleming
Keyword(s):  
Cold Stress ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Controlled Study ◽  
Diurnal Pattern ◽  
Total Thermal Resistance ◽  
Reverse Pattern ◽  
Registration Number ◽  
Randomised Controlled ◽  
Peripheral Temperature

ObjectiveTo investigate thermal balance of infants in a Mongolian winter, and compare the effects of traditional swaddling with an infant sleeping-bag in apartments or traditional tents (Gers).DesignA substudy within a randomised controlled trial.SettingCommunity in Ulaanbaatar, Mongolia.SubjectsA stratified randomly selected sample of 40 swaddled and 40 non-swaddled infants recruited within 48 h of birth.InterventionSleeping-bags and baby outfits of total thermal resistance equivalent to that of swaddled babies.Outcome measureDigital recordings of infants’ core, peripheral, environmental and microenvironmental temperatures at 30-s intervals over 24 h at ages 1 month and 3 months.ResultsIn Gers, indoor temperatures varied greatly (<0–>25°C), but remained between 20°C and 22°C, in apartments. Despite this, heavy wrapping, bed sharing and partial head covering, infant core and peripheral temperatures were similar and no infants showed evidence of significant heat or cold stress whether they were swaddled or in sleeping-bags. At 3 months, infants in sleeping-bags showed the ‘mature’ diurnal pattern of a fall in core temperature after sleep onset, accompanied by a rise in peripheral temperature, with a reverse pattern later in the night, just before awakening. This pattern was not related to room temperature, and was absent in the swaddled infants, suggesting that the mature diurnal pattern may develop later in them.ConclusionsNo evidence of cold stress was found. Swaddling had no identifiable thermal advantages over sleeping-bags during the coldest times, and in centrally heated apartments could contribute to the risk of overheating during the daytime.Trial registration numberISRTN01992617.

scholarly journals Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate: results from a prospective randomised controlled study (the second year of the SURPRISE study)

2018 ◽  
Vol 77 (9) ◽  
pp. 1268-1275 ◽  
Author(s):  
Yuko Kaneko ◽  
Masaru Kato ◽  
Yoshiya Tanaka ◽  
Masayuki Inoo ◽  
Hitomi Kobayashi-Haraoka ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Controlled Study ◽  
Sustained Remission ◽  
Open Label ◽  
Low Disease Activity ◽  
Randomised Controlled Study ◽  
Registration Number ◽  
Second Year ◽  
Randomised Controlled

ObjectiveTo evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate.MethodsThe SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated.ResultsA total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-activity rates were significantly higher in ADD-ON than in SWITCH (55%vs27%, p=0.005). Sustained remission rates at week 104 were 24% for ADD-ON and 14% for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate.ConclusionSustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90% of patients.Trial registration numberNCT01120366; Results.

scholarly journals Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled study

2019 ◽  
Vol 90 (4) ◽  
pp. 451-457 ◽  
Author(s):  
Ryuji Kaji ◽  
Takashi Imai ◽  
Yasuo Iwasaki ◽  
Koichi Okamoto ◽  
Masanori Nakagawa ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Rating Scale ◽  
Controlled Study ◽  
P Value ◽  
High Dose ◽  
Time Interval ◽  
Registration Number ◽  
Randomised Controlled ◽  
Post Hoc ◽  
Lateral Sclerosis

ObjectiveTo evaluate the efficacy and safety of intramuscular ultra-high-dose methylcobalamin in patients with amyotrophic lateral sclerosis (ALS).Methods373 patients with ALS (El Escorial definite or probable; laboratory-supported probable; duration ≤36 months) were randomly assigned to placebo, 25 mg or 50 mg of methylcobalamin groups. The primary endpoints were the time interval to primary events (death or full ventilation support) and changes in the Revised ALS Functional Rating Scale (ALSFRS-R) score from baseline to week 182. Efficacy was also evaluated using post-hoc analyses in patients diagnosed early (entered ≤12 months after symptom onset).ResultsNo significant differences were detected in either primary endpoint (minimal p value=0.087). However, post-hoc analyses of methylcobalamin-treated patients diagnosed and entered early (≤12 months’ duration) showed longer time intervals to the primary event (p<0.025) and less decreases in the ALSFRS-R score (p<0.025) than the placebo group. The incidence of treatment-related adverse events was similar and low in all groups.ConclusionAlthough ultra-high-dose methylcobalamin did not show significant efficacy in the whole cohort, this treatment may prolong survival and retard symptomatic progression without major side effects if started early.Trial registration numberNCT00444613.

scholarly journals Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029460 ◽  
Author(s):  
Elitsa Veneva ◽  
Radka Cholakova ◽  
Ralitsa Raycheva ◽  
Ani Belcheva
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Local Anaesthesia ◽  
Injection Pain ◽  
Rank Test ◽  
Controlled Clinical Trial ◽  
Scientific Publications ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Medical University

IntroductionA current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients.Methods and analysisThe proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8–12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique.Data will be analysed with intention-to-treat concept by Student’s t-test for paired samples, Wilcoxon signed-rank test, p<0.05. Pretest on 20 subjects resulted in n=41 patients sample size.Ethics and disseminationThis study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.Trial registration numberNCT03445182; Pre-results.

scholarly journals Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention (EMT-OCSP): a protocol for a pragmatic, multicentre, observer-blinded, 12-month randomised controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043450
Author(s):  
Muke Zhou ◽  
Jian Guo ◽  
Ning Chen ◽  
Mengmeng Ma ◽  
Shuju Dong ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Risk Factor ◽  
Message Framing ◽  
Potential Interaction ◽  
Controlled Study ◽  
Cvd Risk ◽  
Randomised Controlled Study ◽  
Registration Number ◽  
Randomised Controlled

IntroductionPrimary prevention of cardiovascular disease (CVD) and stroke often fails due to poor adherence among patients to evidence-based prevention recommendations. The proper formatting of messages portraying CVD and stroke risks and interventional benefits may promote individuals’ perception and motivation, adherence to healthy plans and eventual success in achieving risk control. The main objective of this study is to determine whether risk and intervention communication strategies (gain-framed vs loss-framed and long-term vs short-term contexts) and potential interaction thereof have different effects on the optimisation of adherence to clinical preventive management for the endpoint of CVD risk reduction among subjects with at least one CVD risk factor.Methods and analysisThis trial is designed as a 2×2 factorial, observer-blinded multicentre randomised controlled study with four parallel groups. Trial participants are aged 45–80 years and have at least one CVD risk factor. Based on sample size calculations for primary outcome, we plan to enrol 15 000 participants. Data collection will occur at baseline, 6 months and 1 year after randomisation. The primary outcomes are changes in the estimated 10-year CVD risk, estimated lifetime CVD risk and estimated CVD-free life expectancy from baseline to the 1-year follow-up.Ethics and disseminationThis study received approval from the Ethical Committee of West China Hospital, Sichuan University and will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT04450888.

scholarly journals Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study

2018 ◽  
Vol 103 (2) ◽  
pp. 176-180 ◽  
Author(s):  
Tsontcho Ianchulev ◽  
David F Chang ◽  
Edward Koo ◽  
Susan MacDonald ◽  
Ernesto Calvo ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Cell Loss ◽  
Controlled Study ◽  
Endothelial Cell Loss ◽  
Nuclear Fragmentation ◽  
Corrected Visual Acuity ◽  
Randomised Controlled Study ◽  
Registration Number ◽  
Grade 3 ◽  
Randomised Controlled

AimTo assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts.MethodsThis was a prospective single-masked multisurgeon interventional randomised controlled trial (ClinicalTrials.gov NCT02843594) where 101 eyes of 101 subjects with grade 3‒4+ nuclear cataracts were randomised to torsional phacoemulsification alone (controls) or torsional phacoemulsification with adjunctive endocapsular nuclear fragmentation using a manual microinterventional nitinol filament loop device (miLOOP group). Outcome measures were phacoemulsification efficiency as measured by ultrasound energy (cumulative dispersed energy (CDE) units) and fluidics requirements (total irrigation fluid used) as well as incidence of intraoperative and postoperative complications.ResultsOnly high-grade advanced cataracts were enrolled with more than 85% of eyes with baseline best corrected visual acuity (BCVA) of 20/200 or worse in either group. Mean CDE was 53% higher in controls (32.8±24.9 vs 21.4±13.1 with miLOOP assistance) (p=0.004). Endothelial cell loss after surgery was low and similar between groups (7‒8%, p=0.561) One-month BCVA averaged 20/27 Snellen in miLOOP eyes and 20/24 in controls. No direct complications were caused by the miLOOP. In two cases, capsular tears occurred during IOL implantation and in all remaining cases during phacoemulsification, with none occurring during the miLOOP nucleus disassembly part of the procedure.ConclusionsMicrointerventional endocapsular fragmentation with the manual, disposable miLOOP device achieved consistent, ultrasound-free, full-thickness nucleus disassembly and significantly improved overall phaco efficiency in advanced cataracts.Trial registration numberNCT02843594

scholarly journals Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

2016 ◽  
Vol 76 (2) ◽  
pp. 346-354 ◽  
Author(s):  
Won Park ◽  
Dae Hyun Yoo ◽  
Pedro Miranda ◽  
Marek Brzosko ◽  
Piotr Wiland ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Extension Study ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Negative Effects ◽  
Open Label ◽  
Open Label Extension ◽  
Registration Number ◽  
Randomised Controlled ◽  
Maintenance Group

ObjectivesTo investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS).MethodsThis open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group).ResultsOverall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively.ConclusionsThis is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment.Trial registration numberNCT01571206; Results.

Sign in / Sign up

Export Citation Format

Share Document