double blind clinical trial
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2022 ◽  
pp. 1-6
Min Kyoung Kang ◽  
Jae-Kwan Cha ◽  
Dae-il Chang ◽  
Hyun Young Kim ◽  
Jong-Won Chung ◽  

<b><i>Purpose:</i></b> The aim of this study is to investigate the effect of gradual dipyridamole titration and the incidence of dipyridamole-induced headache in patients with ischemic stroke or transient ischemic attack (TIA). <b><i>Methods:</i></b> A randomized, double-blind, double-placebo, parallel group, phase 4 clinical trial (KCT0005457) was conducted between July 1, 2019, and February 25, 2020, at 15 medical centers in South Korea. The study included patients aged &#x3e;19 years diagnosed with a noncardioembolic ischemic stroke or TIA within the previous 3 weeks. The participants were randomized 1:1:1 to receive Adinox® (aspirin 25 mg/dipyridamole 200 mg) and aspirin (100 mg) once daily for the first 2 weeks followed by Adinox® twice daily for 2 weeks (titration group), Adinox® twice daily for 4 weeks (standard group), and aspirin 100 mg once daily for 4 weeks (control group). The primary endpoint was incidence of headache over 4 weeks. The key secondary endpoint was mean cumulative headache. <b><i>Results:</i></b> Ninety-six patients were randomized into the titration (<i>n</i> = 31), standard (<i>n</i> = 32), and control (<i>n</i> = 33) groups. The titration and standard groups (74.1% vs. 74.2%, respectively) showed no difference in the primary endpoint. However, the mean cumulated headache was significantly lower in the titration group than in the standard group (0.31 ± 0.46 vs. 0.58 ± 0.51, <i>p</i> = 0.023). Further, adverse drug reactions were more common in the standard group than in the titration group (28.1% vs. 9.7%, respectively, <i>p</i> = 0.054), although not significantly different. <b><i>Conclusion:</i></b> The titration strategy was effective in lowering the incidence of cumulative dipyridamole-induced headache.

Mehrdad Masoudifar ◽  
Behzad Nazemroaya ◽  
Maryam Raisi

Background: One of the complications of ECT treatment is headache. There is a need to use sedation during ECT. As a result, midazolam has been used to address a safe and effective strategy in this regard. Methods: This study is a double-blind clinical trial that has been performed in three groups: group A, which receives midazolam based on the usual regimen, group B, which receives midazolam after shock, and group C, which is the control group. Patients were asked about headache, nausea, and muscle aches during the recovery time, seizure duration and after becoming fully conscious. Data were analyzed in the PASW version18 software using analysis of variance and repeated measurement tests, ANOVA, independed t and χ2 tests. Results: Analysis showed that the frequency of muscle pain after full consciousness in group C was significantly higher than group B, with group B being higher than group A. χ2 test showed that the frequency of headache, cough and nausea in group C was significantly higher than the two groups A and B. Conclusion: The result of this research showed that midazolam prodrug plays an effective role in preventing post-ECT complications in children. The effect of midazolam before and after ECT on headache, muscle pain and nausea was investigated and compared with the control group. Also, due to its anterograde amnesia, midazolam can reduce the patient's stress in the next visits, and this issue is even more important when the patient is a child.

2022 ◽  
Vol 18 (1) ◽  
Hooman Rafiei Sarvari ◽  
Hamidreza Baigrezaii ◽  
Mohammad Nazarianpirdosti ◽  
Amirhossein Meysami ◽  
Roya Safari-Faramani

Abstract Introduction Non - traumatic headaches are one of the most common causes of referral to hospital emergency. This study aimed to compare the efficacy of intranasal ketamine and intravenous ketorolac on acute non-traumatic headaches. Methods This randomized and double-blind clinical trial was conducted in 2019. One hundred and forty samples were randomly divided into intranasal ketamine (A) and intravenous ketorolac (B). Group (A) received ketamine intranasal (0.75 mg/kg, max 75 mg), and group B received intravenous ketorolac (30 mg). Headache severity was measured on arrival, 30, 60, and 120 min after intervention with Visual Analogue Scale (VAS). The side effects were recorded an hour after the intervention. Result The mean difference of pain intensity 30, 60, and 120 min after the intervention between the two groups was statistically significant (p < 0.001). In the first 30 min, significant changes were observed in the VAS levels of the two groups. These changes were significantly greater in the intranasal ketamine group (p < 0.001). Side effects such as fatigue, dizziness, general discomfort, nausea, increased heart rate, and hypertension were significantly higher in the ketamine group (p < 0.05). Conclusion Intranasal ketamine and intravenous ketorolac both effectively reduced headaches. However, more analgesic effects of intranasal ketamine in a short time can be considered as a selective approach to reducing headaches. Trial registration IRCT20180108038276N3, Registered 29 September 2019. Ethics committee reference number IR.KUMS.REC.1398.068.

2022 ◽  
Vol 11 (6) ◽  
Mahzad Yousefian ◽  
Ali Mohammadian Erdi ◽  
Negin Haghshenas

Background: Dilatation and curettage (D & C) is one of the relatively common surgeries among women. Familiarity with the analgesics, along with their different uses and specific characteristics, can help to determine the best and most appropriate drug to control pain in the patients. Objectives: This study aimed to compare the effects of ketofol, dexmedetomidine, and isofol in anesthesia of candidates for D & C. Methods: In this double-blind clinical trial, 150 candidates for D & C surgeries with ASA class 1 and 2 were included. Patients were randomly divided into three groups. The first group received ketamine + propofol, the second group received dexmedetomidine, and the third group received isofol (isoflurane + propofol). Any hemodynamic changes or respiratory disorders, including apnea or hypoventilation, drop in the level of blood oxygen saturation, and the need for respiratory support, were recorded and compared. Results: Hypoventilation was observed in 47 patients in isofol group, 18 in the dexmedetomidine group, and 42 in ketofol group. Also, 48 patients in the isofol group, eight in the dexmedetomidine group, and 33 in the ketofol group experienced apnea. Moreover, 17 patients in the dexmedetomidine group, 35 in the ketofol group, and eight in the isofol group experienced bradycardia. The rate of bradycardia was significantly higher in the dexmedetomidine group (70%) compared to the other two groups, and the rate of hypotension was significantly higher in the isofol group (P = 0.001). Conclusions: According to the results, dexmedetomidine was associated with fewer complications during general anesthesia in D & C surgery.

Leandro Moura Martins ◽  
Gabriel Guedes Azevedo Cardoso ◽  
Liliane Motta Lima ◽  
Marcia Rezende ◽  
Elisama Sutil ◽  

Nutrients ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 108
Antonella Riva ◽  
Giovanna Petrangolini ◽  
Pietro Allegrini ◽  
Simone Perna ◽  
Attilio Giacosa ◽  

Botanicals are natural alternatives to pharmacological therapies that aim at reducing hypercholesterolemia. In this context, despite bergamot being effective in modulating lipid profile, some subjects failed to achieve a satisfactory response to supplementation. The aim of this study was to evaluate whether the association of 600 mg of bergamot phytosome® (from Citrus Bergamia Risso) and 100 mg of artichoke leaf standardized dry extract (from Cynara cardunculus L.) can be an alternative in patients with mild hypercholesterolemia who are poor responders to bergamot in a 2-month randomized placebo-controlled trial. Sixty overweight adults were randomized into two groups: 30 were supplemented and 30 received a placebo. The metabolic parameters and DXA body composition were evaluated at the start, after 30 and 60 days. Between the two groups, total and LDL cholesterol in the supplemented group (compared to placebo) showed significant decreases overtime. A significant reduction of waist circumference and visceral adipose tissue (VAT) was recorded in the supplemented group (compared to placebo), even in subjects who did not follow a low-calorie diet. In conclusion, the synergism between Citrus Bergamia polyphenols and Cynara cardunculus extracts may be an effective option and may potentially broaden the therapeutic role of botanicals in dyslipidemic patients.

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