scholarly journals Premedication with Oral Alprazolam and Melatonin Combination: A Comparison with Either Alone—A Randomized Controlled Factorial Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Krishna Pokharel ◽  
Mukesh Tripathi ◽  
Pramod Kumar Gupta ◽  
Balkrishna Bhattarai ◽  
Sindhu Khatiwada ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Controlled Trial ◽  
Visual Analogue Score ◽  
Sedation Score ◽  
Combination Drug ◽  
Chi Square ◽  
Double Blind ◽  
Amnesic Effect ◽  
Time Points ◽  
Number Of Patients

We assessed if the addition of melatonin to alprazolam has superior premedication effects compared to either drug alone. A prospective, double blind placebo controlled trial randomly assigned 80 adult patients (ASA 1&2) with a Visual Analogue Score (VAS) for anxiety ≥3 to receive a tablet containing a combination of alprazolam 0.5 mg and melatonin 3 mg, alprazolam 0.5 mg, melatonin 3 mg, or placebo orally 90 min before a standard anesthetic. Primary end points were change in anxiety and sedation score at 15, 30, and 60 min after premedication, and number of patients with loss of memory for the five pictures shown at various time points when assessed after 24 h. One-way ANOVA, Friedman repeated measures analysis of variance, Kruskal Wallis and chi square tests were used as relevant. Combination drug produced the maximum reduction in anxiety VAS (3 (1.0–4.3)) from baseline at 60 min (P<0.05). Sedation scores at various time points and number of patients not recognizing the picture shown at 60 min after premedication were comparable between combination drug and alprazolam alone. Addition of melatonin to alprazolam had superior anxiolysis compared with either drugs alone or placebo. Adding melatonin neither worsened sedation score nor the amnesic effect of alprazolam alone. This study was registered, approved, and released from ClinicalTrials.gov. Identifier number:NCT01486615.

scholarly journals Acute Arginine Supplementation Is Associated with Increased Growth Hormone in Younger Healthy Males: A Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 609-609
Author(s):  
John Apolzan ◽  
Jennifer Rood ◽  
Robbie Beyl ◽  
Shengping Yang ◽  
Frank Greenway ◽  
...  
Keyword(s):  
Growth Hormone ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Hormone Secretion ◽  
Growth Hormone Secretion ◽  
Sex Hormone Binding Globulin ◽  
Double Blind ◽  
Time Points ◽  
Arginine Supplementation ◽  
Time Point

Abstract Objectives Assess the effects of the amino acid arginine on growth hormone (GH), other metabolites, and mood. Arginine is reported to increase GH, but the mechanism is not known. It was hypothesized prolactin mediated this effect since it is similar in structure to GH and, like GH, is secreted by the pituitary gland. Methods Thirty physically active healthy young males (18–39 y; 18.5–25 kg/m2) were enrolled in a randomized, double-blind, placebo-controlled, crossover trial. Two days prior and 1 day following each treatment a standardized diet was provided that maintained arginine at 3–5 g/d. Arginine or placebo treatments in the form of a beverage were consumed after an overnight fast. Treatment conditions were separated by at least a one week washout period. The beverages contained either 10 g of arginine or 0 g (placebo). Blood was collected at baseline and 1.5, 3.0, and 24 hr post treatment. Plasma GH, prolactin, amino acids, glucose, insulin, triacylglycerols, thyroid hormones, sex hormone binding globulin (SHBG), testosterone, cortisol, and dehydroepiandrosterone (DHEA) were assessed. The Profile of Mood States (POMS) was administered at the same time as blood draws. Repeated measures ANOVAs were used to estimate treatment effects at each time point. Results Arginine increased plasma arginine at 1.5, 3.0, and 24 hr (P ≤ 0.001) and GH at 24 hr (P ˂ 0.05) but not other time points. Arginine increased glucose and insulin at the 1.5 and 3.0 hr (P ˂ 0.05) but not 24 hr. Arginine did not affect any other dependent measure (P &gt; 0.05) including prolactin. When only individuals with detectable levels of GH (responders; n = 16) were analyzed separately, arginine increased GH at the 1.5 (P ˂ 0.05) but not the 3.0 or 24 hr time points. Among the responders, arginine also increased thyroid stimulating hormone (TSH) at the 24 hr time point (P ˂ 0.05) but not the 1.5 and 3.0 hr time points. Conclusions Arginine supplementation modestly increased growth hormone. Despite their similar structures, prolactin secretion was not elevated following arginine supplementation, thus another mechanism is responsible for growth hormone secretion. Funding Sources DoD and NIH P30DK072476. Views expressed are those of the authors and do not reflect official policy of the Army, DoD, or US Government.

scholarly journals Hystroscopic cornual nerve block in operative hysteroscopy: a Randomized controlled trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
M I Amer ◽  
M M Abdelaleem ◽  
Y M Elrefaey
Keyword(s):  
Nerve Block ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
Visual Analogue Score ◽  
University Hospital ◽  
Controlled Study ◽  
Double Blind ◽  
Operative Hysteroscopy ◽  
Number Of Patients ◽  
Ethical Approval

Abstract Background Hysteroscopy has become a standard investigation for a lot of gynecological cases and found to be effective in detecting intrauterine pathology and treating it. It is usually performed as an outpatient procedure under either local or no anesthesia. Aim of the Work to assess the anesthetic efficacy of intracornual nerve block versus placebo in reducing pain & discomfort during operative hysteroscopy. Patients and Methods This randomized, double-blind, placebo-controlled study was conducted on 58 patients at the Early Cancer Detection and Endoscopy Unit (Ain Shams university Hospital) after taking Full ethical approval for the study. Patients referred for outpatient hysteroscopy (between march 2018 and December 2018) were informed about the possible role of intracornual nerve block in reducing pain that could be experienced during the procedure, and were asked to participate. Signed informed consent was obtained from all patients who agreed to participate in the study. Results Among the 42 women who underwent successful operative intervention, the visual analogue score for assessment of intra-operative pain was statistically significantly lower in the LA-ICOB group compared to the placebo-ICOB group. In the same context, the number of patients requiring extra analgesia (either as NSAIDs or opioid analgesics) was statistically significantly larger in the placebo-ICOB group compared to the LA-ICOB group. Conclusion This study proved that the use of intracornual nerve block in operative hysteroscopy is both beneficial and effective in reducing pain and discomfort that could associate operative hysteroscopy procedure.

scholarly journals Ketorolac vs. tramadol for pain management after abdominal surgery in children

2014 ◽  
Vol 54 (2) ◽  
pp. 118
Author(s):  
Iman Hendarman ◽  
Silvia Triratna ◽  
Muhammad Kamaludin ◽  
Theodorus Theodorus
Keyword(s):  
Abdominal Surgery ◽  
Clinical Success ◽  
Controlled Trial ◽  
Pain Scale ◽  
Chi Square ◽  
Double Blind ◽  
Number Of Patients ◽  
Significant Difference ◽  
Duration Of Surgery ◽  
Intravenous Ketorolac

Background Tramadol is a pure analgesic widely used forpostoperative treatment and well tolerated by children. Howevet;it has only a 50% efficacy. Ketorolac, a non􀁙steroid anri􀁙inflammation drug (NSAID), is widely used in adults and has upto 85% clinical efficacy. Data supporting the use of ketorolac inchildren has been limited.Objective To compare the clinical efficacies of intravenousketorolac and tramadol for moderate􀁙to􀁙severe pain managementafter abdominal surgery in children.Methods A double􀁙blind controlled trial was conducted in Moh.Hoesin Hospital, Palembang, from January to June 2012. Subjectswere postoperative children aged 1 􀁙 7 years who met the inclusioncriteria. T hey were randomized into two groups who receivedeither intravenous ketorolac or tramadol. Subjects assessedtheir pain level using the Face, Legs, Anns, Cry and Consolability(FLACC) pain scale. T he FLACC scores ::::;3 were considered toindicate clinical success of the intervention. Data were analyzedby T􀁙test, Chi􀁙square test, and Fischer's exact test.Results Of the 60 subjects who underwent abdominal surgery withgeneral anesthesia, 31 (52%) were boys and 29 (48%) were girls.Subjects' mean age and body weight were 3.7 (SD 1.82) years and12.6 (SD 2.85) kg, respectively. Mean duration of surgery was 71.7(SD 21.11) minutes and mean post􀁙operative FLACC score was6.6 (SD 0.5). Eight subjects dropped out of the study. Efficacies ofketorolac and tramadol were not significantly different at 21/26 and17/26, respectively (P=OJ5). In addition, there was no significantdifference in the number of patients experiencing a >3 FLACCscore decline between ketorolac and tramadol groups (P=0.61).Conclusion T here is no significant difference in the efficaciesof intravenous ketorolac and tramadol for moderate􀁙to􀁙severepain management after abdominal surgery in children. [PaediatrIndones.2014;54:118.21.].

Optimizing chair time in infusion centers using intravenous cetirizine premedication for the prevention of hypersensitivity infusion reactions.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13508-e13508
Author(s):  
Julio Antonio Peguero ◽  
Ahmed Ayad ◽  
Stacia Young-Wesenberg ◽  
Teresa Yang ◽  
Janine North ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Quality Care ◽  
Primary Objective ◽  
Double Blind ◽  
Acute Urticaria ◽  
Number Of Patients ◽  
Study Results ◽  
Secondary Endpoints ◽  
Infusion Reactions ◽  
Anti Cd20

e13508 Background: Oncology infusion centers are increasingly focused on improving operational efficiencies and patient satisfaction, while maintaining quality care. One key component is optimizing chair time, which has been especially important for patient safety during the COVID-19 pandemic to reduce risk of transmission. Many infusions require antihistamine premedication to reduce the risk of hypersensitivity infusion reactions (IRs). The two IV options are IV diphenhydramine and IV cetirizine, which have a quicker onset than oral options and can be administered IV push. In treating acute urticaria, IV cetirizine was shown to be comparable to IV diphenhydramine, with fewer side effects, and it may be effective for preventing IRs with improved chair time. Methods: A randomized, double-blind phase 2 study evaluating premedication with single dose IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 34 patients receiving paclitaxel, rituximab, its biosimilar or obinutuzumab (first cycle, retreatment after 6 months or with persistent IRs). The primary objective was the incidence of IRs after premedication. Secondary endpoints included sedation due to antihistamines and time to readiness for discharge. Sedation was reported by patients on a scale of 0-4 (0 = none to 4 = extremely severe). No formal statistical analyses were planned given the exploratory nature of the study. Results: Adults primarily with cancer (n = 31 [91%]) were enrolled during the COVID-19 pandemic, from March 25 to November 23, 2020. The median age was 65 and 67 years in the IV cetirizine and diphenhydramine groups, respectively. The number of patients with IRs was 2/17 (11.8%) with IV cetirizine versus 3/17 (17.6%) with IV diphenhydramine. The mean sedation score in the IV cetirizine group compared to the IV diphenhydramine group was lower at all time points, including at discharge (0.1 vs 0.4, respectively). Mean time to discharge was 24 minutes less with IV cetirizine (4.3 hours [1.5]) versus IV diphenhydramine (4.7 hours [1.2]). This difference was greater (30 minutes less) in those ≥65 years of age (4.4 [1.3] vs 4.9 [1.0] hours). Regardless of whether patients received paclitaxel (n = 9) or an anti-CD20 (n = 25), patients had less chair time when premedicated with IV cetirizine. There were fewer treatment-related adverse events (AEs) with IV cetirizine (2 events) than with IV diphenhydramine (4 events). Conclusions: This was the first randomized, controlled trial evaluating IV antihistamine premedication for IRs and chair time. It was shown that IV cetirizine can prevent IRs, with less sedation, fewer related AEs and reduced chair time compared to IV diphenhydramine. This improves infusion center operations and patient experience. Clinical trial information: NCT04189588.

Effects of Proximal Priority and Distal Priority Robotic Priming Techniques With Impairment-Oriented Training of Upper Limb Functions in Patients With Chronic Stroke: Study Protocol For A Single-Blind, Randomized Controlled Trial

2021 ◽  
Author(s):  
Yi-chen Lee ◽  
Yi-chun Li ◽  
KEH-CHUNG LIN ◽  
Chia-ling Chen ◽  
Yi-hsuan Wu ◽  
...  
Keyword(s):  
Upper Extremity ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Scientific Evidence ◽  
Body Part ◽  
Chronic Stroke ◽  
Comparative Efficacy ◽  
Chi Square ◽  
Robotic Therapy ◽  
Single Blind

Abstract BackgroundThe sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI). MethodsThis single-blind, randomized, comparative efficacy study will involve 40 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI. DiscussionThrough manipulating the sequence of applying wrist and forearm robots in therapy, this study will attempt to examine empirically the priming effect of proximal or distal priority robotic therapy in upper extremity impairment-oriented training for people with stroke. The findings will provide directions for further studies and empirical implications for clinical practice in upper extremity rehabilitation after stroke.Trial RegistrationThis trial was registered on June 23, 2020, at www.clinicaltrials.gov (NCT04446273).

scholarly journals The Use of Milrinone Versus Conventional Treatment for the Management of Life-Threatening Bronchial Asthma

2019 ◽  
Vol 13 (1) ◽  
pp. 12-17 ◽  
Author(s):  
Amr Sobhy ◽  
Doaa M. K. Eldin ◽  
Hany V. Zaki
Keyword(s):  
Bronchial Asthma ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Blood Gases ◽  
Categorical Variables ◽  
Chi Square ◽  
Arterial Blood ◽  
Number Of Patients ◽  
Significant Difference ◽  
Life Threatening

Background and Aims: In our study, we investigated the effectiveness of intravenous milrinone in life-threatening bronchial asthma as compared to conventional treatment. Methods: Fifty patients aged 18-50 years, presenting with life-threatening asthma were enrolled in a Randomised Controlled Trial (RCT). They were randomly allocated into Group C (25 patients): who received the standard pharmacotherapy and placebo, and Group M (25 patients): who in addition to the standard therapy, received 25 μg milrinone as an initial slow IV bolus diluted in 10 ml of normal saline. The following data were recorded: PEFR (Peak Expiratory Flow Rate) expressed as a percentage of the patient’s previous value, Respiratory Rate (RR), MABP (Mean Arterial Blood Pressure), arterial blood gases, and the number of patients requiring mechanical ventilation. Differences between groups were tested using Analysis of Variance (ANOVA) for quantitative variables with post hoc using the Least Significant Difference (LSD) test, and Chi square test for categorical variables. Results: Group M showed marked improvement in PEFR that was highly significant (P < 0.001) 10 min after injection and significant after one hour from the start of treatment in comparison to Group C. There was also an improvement in RR and PO2 that was significant in group M. Milrinone was associated with a reduction in MABP only after 10 min from injection, and showed a statistically significant decrease in the number of patients requiring mechanical ventilator support (P ˂ 0.05). Conclusion: Milronine is a promising agent as a rescue drug in the treatment of life-threatening bronchial asthma.

scholarly journals A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue

Medicines ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 47
Author(s):  
Abhijit Rathi ◽  
Swati B. Jadhav ◽  
Neha Shah
Keyword(s):  
Treatment Efficacy ◽  
Controlled Trial ◽  
Placebo Treatment ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Time Points ◽  
Randomized Controlled ◽  
Cognitive Disturbances ◽  
Oral Supplements

Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients’ functional status and quality of life.

The Efficacy of Nebulized Budesonide in Dexamethasone-treated Outpatients With Croup

PEDIATRICS ◽  
1996 ◽  
Vol 97 (4) ◽  
pp. 463-466
Author(s):  
Terry P. Klassen ◽  
Lise K. Watters ◽  
Mark E. Feldman ◽  
Teresa Sutcliffe ◽  
Peter C. Rowe
Keyword(s):  
Controlled Trial ◽  
Tertiary Care ◽  
Airway Disease ◽  
Primary Outcome Measure ◽  
Lower Airway ◽  
Inspiratory Stridor ◽  
Double Blind ◽  
Oral Dexamethasone ◽  
Number Of Patients ◽  
Pediatric Outpatients

Objective. To determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with 0.6 mg/kg oral dexamethasone. Design. Randomized, double-blind, placebo-controlled trial. Setting. Emergency department of a tertiary-care pediatric hospital with 47 000 visits per year. Participants. Children 3 months to 5 years of age with a syndrome consisting of hoarseness, inspiratory stridor, and barking cough and a croup score of 3 or greater after at least 15 minutes of mist therapy. Patients were excluded from the study if they had diagnoses of epiglottitis, chronic upper or lower airway disease (not including asthma), or severe croup or had received corticosteroids within the preceding 2 weeks. Intervention. All patients received 0.6 mg/kg oral dexamethasone and were randomly assigned to receive 4 mL (2 mg) of budesonide solution (n = 25) or 4 mL of 0.9% saline solution (n = 25) by updraft nebulizer with a continuous flow of oxygen at 5 to 6 L/min. Main Outcome Measures. The primary outcome measure was the proportion of patients in each group who had clinically important changes (two points) in the croup score during the 4 hours after treatment. Results. Eighty-four percent (n = 21) of the patients who received budesonide had clinically important responses, compared with 56% (n = 14) in the placebo group. The number of patients who would need to be treated with nebulized budesonide for one patient to have a clinically important response is four patients. Conclusions. Despite receiving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide.

scholarly journals Randomized controlled trial of erdosteine for acute cough in children with colds

2011 ◽  
Vol 51 (2) ◽  
pp. 111
Author(s):  
Yenny Yenny ◽  
Roni Naning ◽  
Amalia Setyati
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Improvement ◽  
Common Cold ◽  
Controlled Trial ◽  
Research Subjects ◽  
Acute Cough ◽  
Chi Square ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference

Background T h e prevalence of the common cold in children is high, v.ith 30% of cases exhibiting an acute cough, the most common complaint by parents. Erdosteine, a recently developed cough medicine, is available for children. Erdosteine has been reported to increase mucodliary clearance, act as an antioxidant and prevent bacterial adhesion.Objective To assess the clinical improvement in acute cough in children \\lith a common cold taking erdosteine vs. a placebo.Methods We conducted a double􀀾blind, randomized, controlled trial at the Public Health Center of Gedongtengen, Yogyakarta with 140 children selected by a consecutive sampling method. Research subjects were randomized by computer program into two treatment groups, those receiving erdosteine therapy and those receiving a placebo. Both groups were monitored for 6 days. A scoring system was used to assess the improvement of acute cough symptoms and analyzed by Chi-square test.Results No significant differences in basic characteristics, cough severity, or environment were found among the 140 children with common cold in the two groups. After 6 days of treatment, no significant difference in clinical improvement of acute cough was found between the erdosteine (65 subjects improved out of 70) and placebo groups (62/70),92.5% and 88.6%, respectively (P=0.382).Conclusion Erdosteine was not more effective than the placebo for treatment of acute cough in children with common cold.

An improvement in self-care behaviour in heart failure patients lead to better management of hypertension

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.S Sahlin ◽  
S Gerward
Keyword(s):  
Heart Failure ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Chi Square ◽  
Home Based ◽  
Number Of Patients

Abstract Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg &lt; MAP &lt;100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP &gt;100 mmHg, with 22% in the CG versus 16% in the IG having MAP &gt;100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None

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