• 제목/요약/키워드: Prospective randomized trial

검색결과 164건 처리시간 0.023초

만성 난치성 기침에 대한 기침 억제 요법의 효과 (The Benefit of Supplemental Cough Suppression Therapy for Chronic Refractory Cough)

  • 유용준;박혜진;한명월;김지원
    • 대한후두음성언어의학회지
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    • 제33권1호
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    • pp.26-30
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    • 2022
  • Background and Objectives Cough suppression therapy (CST) is a physiotherapy that can be used for patients with chronic refractory cough (CRC). We aimed to investigate the efficacy of CST for CRC. Materials and Method A prospective randomized controlled trial was conducted in 27 patients with CRC. Participants were randomized to receive either standard mucolytic medications for CRC combined with supplemental CST (CST group) or standard medications alone (control group). CST consists of laryngeal hygiene management, humidification, cough suppression technique, breathing method, and counseling. We assessed the symptoms change at baseline and week 4 with the Leicester Cough Questionnaire (LCQ). Secondary efficacy outcomes included the degree of cough Visual Analog Scale (VAS) score (0 to 100 scale). Results From 2019 to 2021, 14 CST group patients and 13 control group patients were included. The improvement was significantly greater in the CST group than in the control group for cough VAS score (36.67 to 13.33 vs. 74.29 to 16.43, p<0.001). Patients in the CST group had a significant improvement in total (70.14 to 107.71, p=0.005), physical (31.42 to 43.86, p=0.015), psychological (23.57 to 40.14, p=0.003), and social (15.14 to 23.71, p=0.005) LCQ scores. However, there was not a significant pre- to post-treatment LCQ score improvement in control group. Conclusion CST might be an effective supplemental intervention for CRC.

Efficacy and safety of low dose oral ketamine for controlling pain and distress during intravenous cannulation in children: a double-blind, randomized, placebo-controlled trial

  • Bagheri, Mahdi;Soltani, Alireza Ebrahim;Qorbani, Mostafa;Sureda, Antoni;Faghihi, Toktam
    • The Korean Journal of Pain
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    • 제35권3호
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    • pp.311-318
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    • 2022
  • Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.

Glenohumeral versus subacromial steroid injections for impingement syndrome with mild stiffness: a randomized controlled trial

  • Yong-Tae Kim;Tae-Yeong Kim;Jun-Beom Lee;Jung-Taek Hwang
    • Clinics in Shoulder and Elbow
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    • 제26권4호
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    • pp.390-396
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    • 2023
  • Background: The subacromial (SA) space is a commonly used injection site for treatment of impingement syndrome. For shoulder stiffness, glenohumeral (GH) injections are commonly performed. However, in cases of impingement syndrome with mild shoulder stiffness, the optimal site of steroid injection has yet to be identified. Methods: This prospective, randomized study compared the short-term outcomes of ultrasound-guided GH and SA steroid injections in patients who were diagnosed with impingement syndrome and mild stiffness. Each group comprised 24 patients who received either a GH or SA injection of 40 mg of triamcinolone. Range of motion and clinical scores were assessed before and 3, 7, and 13 weeks after the injection. Results: GH and SA injections significantly improved the range of motion and clinical scores after 13 weeks of follow-up. Notably, targeting the GH joint resulted in an earlier gain of forward elevation, external rotation, and internal rotation in 3 weeks (P<0.001, P=0.012, and P=0.002, respectively) and of internal rotation and a Constant-Murley score in 7 weeks (P<0.001 and P=0.046). Subsequent measurements were similar between the groups and showed a steady improvement in all ranges of motion and clinical scores. Conclusions: GH injections may be more favorable than SA injections for treatment of impingement syndrome with mild stiffness, especially in improving the range of motion in the early period. However, the procedures showed similar outcomes after 3 months. Level of evidence: I.

Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test

  • Chang-Hwan Yoon;Jihong Jang;Seung Ho Hur;Jun-Hee Lee;Seung Hwan Han;Soon-Jun Hong;Kiyuk Chang;In-Ho Chae
    • Korean Circulation Journal
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    • 제52권5호
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    • pp.354-364
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    • 2022
  • Background and objectives: To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). Methods: This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. Results: We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. Conclusions: The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.

Two-year survival analysis of twisted wire fixed retainer versus spiral wire and fiber-reinforced composite retainers: a preliminary explorative single-blind randomized clinical trial

  • Sobouti, Farhad;Rakhshan, Vahid;Saravi, Mahdi Gholamrezaei;Zamanian, Ali;Shariati, Mahsa
    • 대한치과교정학회지
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    • 제46권2호
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    • pp.104-110
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    • 2016
  • Objective: Traditional retainers (both metal and fiber-reinforced composite [FRC]) have limitations, and a retainer made from more flexible ligature wires might be advantageous. We aimed to compare an experimental design with two traditional retainers. Methods: In this prospective preliminary clinical trial, 150 post-treatment patients were enrolled and randomly divided into three groups of 50 patients each to receive mandibular canine-to-canine retainers made of FRC, flexible spiral wire (FSW), and twisted wire (TW). The patients were monitored monthly. The time at which the first signs of breakage/debonding were detected was recorded. The success rates of the retainers were compared using chi-squared, Kaplan-Meier, and Cox proportional-hazard regression analyses (${\alpha}=0.05$). Results: In total, 42 patients in the FRC group, 41 in the FSW group, and 45 in the TW group completed the study. The 2-year failure rates were 35.7% in the FRC group, 26.8% in the FSW group, and 17.8% in the TW group. These rates differed insignificantly (chi-squared p = 0.167). According to the Kaplan-Meier analysis, failure occurred at 19.95 months in the FRC group, 21.37 months in the FSW group, and 22.36 months in the TW group. The differences between the survival rates in the three groups were not significant (Cox regression p = 0.146). Conclusions: Although the failure rate of the experimental retainer was two times lower than that of the FRC retainer, the difference was not statistically significant. The experimental TW retainer was successful, and larger studies are warranted to verify these results.

Cost Effective Analysis of Recall Methods for Cervical Cancer Screening in Selangor - Results from a Prospective Randomized Controlled Trial

  • Abdul Rashid, Rima Marhayu;Ramli, Sophia;John, Jennifer;Dahlui, Maznah
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권13호
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    • pp.5143-5147
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    • 2014
  • Cervical cancer screening in Malaysia is by opportunistic Pap smear which contributes to the low uptake rate. To overcome this, a pilot project called the SIPPS program (translated as information system of Pap smear program) had been introduced whereby women aged 20-65 years old are invited for Pap smear and receive recall to repeat the test. This study aimed at determining which recall method is most cost-effective in getting women to repeat Pap smear. A randomised control trial was conducted where one thousand women were recalled for repeat smear either by registered letter, phone messages, phone call or the usual postal letter. The total cost applied for cost-effectiveness analysis includes the cost of sending letter for first invitation, cost of the recall method and cost of two Pap smears. Cost-effective analysis (CEA) of Pap smear uptake by each recall method was then performed. The uptake of Pap smear by postal letter, registered letters, SMS and phone calls were 18.8%, 20.0%, 21.6% and 34.4%, respectively (p<0.05). The CER for the recall method was lowest by phone call compared to other interventions; RM 69.18 (SD RM 0.14) compared to RM 106.53 (SD RM 0.13), RM 134.02 (SD RM 0.15) and RM 136.38 (SD RM 0.11) for SMS, registered letter and letter, respectively. ICER showed that it is most cost saving if the usual method of recall by postal letter be changed to recall by phone call. The possibility of letter as a recall for repeat Pap smear to reach the women is higher compared to sending SMS or making phone call. However, getting women to do repeat Pap smear is better with phone call which allows direct communication. Despite the high cost of the phone call as a recall method for repeat Pap smear, it is the most cost-effective method compared to others.

2000년부터 독일에서 수행된 대규모 침 임상연구들에 대한 고찰: ASH, ART, ARC, GERAC (Review of the Large-Scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC)

  • 윤주연;한국인;정진수;이승호;장인수
    • Korean Journal of Acupuncture
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    • 제30권1호
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    • pp.21-26
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    • 2013
  • Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

Effect of the pulmonary recruitment maneuver on pain after laparoscopic gynecological oncologic surgery: a prospective randomized trial

  • Gungorduk, Kemal;Asicioglu, Osman;Ozdemir, Isa Aykut
    • Journal of Gynecologic Oncology
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    • 제29권6호
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    • pp.92.1-92.9
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    • 2018
  • Objective: To evaluate the effectiveness of the pulmonary recruitment maneuver (PRM) at the end of the operation to decrease laparoscopy-induced abdominal or shoulder pain after gynecological oncologic surgery. Methods: In total, 113 women undergoing laparoscopic surgery for malignant or premalignant gynecological lesions were assigned randomly to two groups: the PRM group (the patient was placed in the Trendelenburg position ($30^{\circ}$) and the PRM, consisting of two manual pulmonary inflations to a maximum pressure of $40cmH_2O$) (n=54) and the control group (n=52). Postoperative shoulder and abdominal pain was assessed 12, 24, and 48 hours later using a visual analog scale (0-10). In addition, the incidence of post-discharge nausea and vomiting was recorded until 48 hours after discharge. Results: Postoperative shoulder pain at 12 and 24 hours was significantly less severe in the PRM group ($2.2{\pm}0.5$ and $2.0{\pm}0.4$) than in the control group ($4.0{\pm}0.5$ and $3.9{\pm}0.4$; both p<0.001). The PRM significantly reduced the severity of upper abdominal pain at 12 and 24 h compared with the control group ($3.1{\pm}0.4$ and $2.9{\pm}0.4$ vs. $2.9{\pm}0.5$ and $4.9{\pm}0.5$; both p<0.001). The analgesic requirement during the postoperative period was similar in the two groups (control group, 78.8%; PRM group, 75.9%; p=0.719). Conclusion: The PRM effectively and safely reduced postoperative shoulder and upper abdominal pain levels in patients undergoing laparoscopic gynecological oncologic surgery. Trial registry at ClinicalTrials.gov, NCT01940042.

Comparative evaluation of efficacy of external vibrating device and counterstimulation on child's dental anxiety and pain perception during local anesthetic administration: a clinical trial

  • Sahithi, Varada;Saikiran, Kanamarlapudi Venkata;Nunna, Mahesh;Elicherla, Sainath Reddy;Challa, Ramasubba Reddy;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권4호
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    • pp.345-355
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    • 2021
  • Background: This study aimed to evaluate the efficacy of external vibrating devices and counterstimulation on a child's dental anxiety, apprehension, and pain perception during local anesthetic administration. Methods: This was a prospective, randomized, parallel-arm, single-blinded interventional, clinical trial. One hundred children aged 4-11 years, requiring pulp therapy or extraction under local anesthesia (LA), were recruited and allocated equally into two groups (1:1) based on the interventions used: Group BD (n = 50) received vibration using a Buzzy® device {MMJ Labs, Atlanta, GE, USA} as a behavior guidance technique; Group CS (n = 50) received counterstimulation for the same technique. Anxiety levels [Venham's Clinical Anxiety Rating Scale (VCARS), Venham Picture Test (VPT), Pulse oximeter {Gibson, Fingertip Pulse Oximeter}, Beijing, China)] were assessed before, during, and after LA administration, while pain perception [Wong-Baker Faces Pain Rating Scale (WBFPS), Visual Analogue Scale (VAS)] was evaluated immediately after injection. Statistical analysis was performed using the Student's t-test to assess the mean difference between the two groups and the repeated measures ANOVA for testing the mean difference in the pulse rates. Statistical significance was set at P < 0.05. Results: Significant differences in mean pulse rate values were observed in both groups. In contrast, the children in the BD group had higher diminution (P < 0.05), whereas the mean VCARS and VPT scores were conspicuous (P < 0.05). Based on the mean WBFPS and VAS scores, delayed pain perception after LA injection was more prominent in the BD group than in the CS group. Conclusion: External vibration using a Buzzy® device is comparatively better than counterstimulation in alleviating needle-associated anxiety in children requiring extraction and pulpectomy.

부분층화상을 입은 외래 환자에서 이부프로펜 방출성 드레싱 제재(Biatain Ibu®)의 창상부위 통증의 경감 효과에 대한 연구 (Pain Relief Efficacy of Ibuprofen Releasing Foam Dressing (Biatain Ibu®) on Outpatient Patient with Partial Thickness Burn Wound)

  • 이준호;최봉규;이진호;김재원
    • 대한화상학회지
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    • 제22권1호
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    • pp.15-19
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    • 2019
  • Purpose: Pain management in burn treatment is important in improving wound healing and quality of life. Ibuprofen is a proven pain relieving agent in patients with partial thickness burn by intraveous injection. The purpose of this study is to evaluate the efficacy of Biatain Ibu® (polyurethane foam containing ibuprofen) in pain control for outpatients with partial thickness burns. Methods: A prospective randomized clinical trial was performed in outpatients with partial thickness burn from August 1, 2017 to July 31, 2018. Acute pain, chronic pain, complications, days for re-epithelialization and patient's satisfaction were compared between Biatain Ibu® and Biatain® groups. Results: A total of 20 patients (Biatain Ibu®, n=10; Biatain®, n=10) were assessed in the trial. On Burn days 3, 5, 7, 11, 13, and 15, the acute pain levels were significantly lower in the Biatain Ibu® group than in the Biatain® group. Complications, chronic pain levels and days for re-epithelialization were not significantly different between the two groups. Patient's satisfaction was not statistically significant but was higher in the Biatain Ibu® group. Conclusion: Biatain Ibu® is effective in relieving pain in outpatients with partial thickness burn without decreasing patient satisfaction, wound healing ability or developing any complications.