scholarly journals Intravenous Bolus Fentanyl vs. Rectal Acetaminophen in Outcome and Quality of Anesthesia in Infants Undergoing Pyloromyotomy: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Behzad Aliakbari Sharabiani ◽  
Daryosh Sheikhzadeh ◽  
Sahar Akbari ◽  
Nasim Arjmand ◽  
Sina Parsay ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Preoperative Evaluation ◽  
Hypertrophic Pyloric Stenosis ◽  
Vital Signs ◽  
Surgical Reconstruction ◽  
Anesthesia Induction ◽  
Time Duration ◽  
Significant Difference ◽  
Double Blinded

Abstract Background Hypertrophic Pyloric Stenosis (HPS) is one of the most common diseases requiring surgery in infants. Regardless of recruited surgical reconstruction techniques, preoperative evaluation, using proper anesthesia induction, perioperative, and postoperative care are the main determining factors in the outcome of these patients. This study aimed to evaluate and compare the premedication with intravenous fentanyl versus rectal acetaminophen on the anesthesia-related outcome of patients. Methods In this double-blinded randomized clinical trial, 24 infants who were managed to underwent a pyloromyotomy surgery due to the HPS were enrolled. Patients then randomly allocated into two groups of Fentanyl (F) or Acetaminophen (A). Anesthesia procedure was initiated with premedication with midazolam (0.03 mg/kg) co-administrated with fentanyl (1 µg/kg) in group F, and rectal acetaminophen (40 mg/kg) administrated 20 minutes prior to midazolam (0.03 mg/kg) in group A individuals. All patients’ vital signs, the period of each step of anesthesia, and the incidence of apnea were measured and recorded. Results Although the time duration from anesthesia termination till extubation and the recovery time were relatively shorter among the patients of the acetaminophen group, there were no statistically significant differences between the two groups. Patients in the acetaminophen group showed a lower level of pain in all evaluated timelines than those who were treated with fentanyl (p < 0.05). There was no statistically significant difference between the apnea incidence in two groups. Conclusion The use of rectal acetaminophen in infants who are planning to undergo pyloromyotomy due to HPS offers a better treatment outcome than fentanyl. Trial Registration: This study was approved by the Ethics Committee of Tabriz University of Medical Sciences under the registry code of IR.TBZMED.REC.1397.511. It was also registered in Iranian Registry of Clinical Trials (IRCT). The trial’s registration number (TRN) is IRCT20180726040601N1 ‘retrospectively registered’

scholarly journals A comparative study on the effect of calcitriol and cinacalcet on hyperparathyroidism in hemodialysis patients; a double-blinded randomized clinical trial

2021 ◽  
Vol 11 (1) ◽  
pp. e12-e12
Author(s):  
Saeed Mardani ◽  
Faranak Sadat Filsouf
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Hemodialysis Patients ◽  
Significant Difference ◽  
Before And After ◽  
Calcium Phosphorus ◽  
Stage Renal Disease ◽  
Double Blinded ◽  
End Stage ◽  
Calcium And Phosphate Metabolism

Introduction:Chronic kidney disease (CKD) has lots of complication like calcium and phosphate metabolism disorders, hyperparathyroidism, vitamin D deficiency and metabolic acidosis. Objectives: The aim of this study was to determine and compare the effect of calcitriol and cinacalcet on hyperparathyroidism in hemodialysis patients due to end-stage renal disease (ESRD). Patients and Methods: This study was a double-blinded randomized clinical trial, which was conducted on 60 hemodialysis patients in 2017-2018. The patients were randomly assigned to two groups of 30 patients, which one group was treated with cinacalcet and the other group was treated with calcitriol. During this study, phosphorus, calcium and iPTH were measured. Results: The results showed that in the group treated with cinacalcet, the amount of calcium [t(22)=0.294, P>0.05] and the amount of phosphorus [t(22)=1.87, P>0.05] did not change significantly while iPTH values before and after the study had statistically significant difference [t(22)=4.37, P<0.05]. In group treated with calcitriol, the calcium, phosphorus and iPTH values did not change significantly (P>0.05). Calcium changes in the cinacalcet group compared to the calcitriol group [t (47) =-1.14, P>0.05] and also, the amount of phosphorus changes [t (47) =-1.022, P>0.05] was not statistically significant. The iPTH changes were not statistically significant between the two groups however iPTH in the calcitriol group was higher than the cinacalcet group [t (47) =-1.13, P>0.05]. Conclusion: In contrast to calcitriol, cinacalcet significantly reduced iPTH and did not significantly change calcium and phosphorus levels. Trial Registration: The trial was registered by Iranian Registry of Clinical Trials (IRCT) (identifier: IRCT20190702044076N1; https://en.irct.ir/trial/40547, Ethical code# IR.SKUMS.REC.1397.026).

scholarly journals Comparing the efficacy and safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for sedation in colonoscopy patients: A double-blinded randomized clinical trial

2021 ◽  
Vol 20 ◽  
Author(s):  
Reza Aminnejad ◽  
Ahmad Hormati ◽  
Hamed Shafiee ◽  
Faezeh Alemi ◽  
Maryam Hormati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Score ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Vital Signs ◽  
P Value ◽  
Chi Square ◽  
Ramsay Sedation Scale ◽  
Repeated Measures Analysis ◽  
Double Blinded

Background: In this double-blinded randomized clinical trial, we aimed to compare the safety and efficacy of a combination of dexmedetomidine and ketamine [DK] with propofol and fentanyl [PF] for sedation in colonoscopy patients. Methods: In this study, 64 patients who underwent colonoscopy were randomized into two groups: 1) A, which received PF, and 2) B, which received DK for sedation. Among 64 patients, 31 patients were included in PF, and 33 patients were included in the DK group. Both groups were similar in terms of demographics. Patients’ sedation score (based on Ramsay sedation scale) and vital signs were recorded at 2, 5, 10, and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea, and vomiting, along with gastroenterologist satisfaction and patients’ pain score (based on Wong-Baker faces pain assessment scale), were recorded by a checklist. Data were analyzed by SPSS v.18 software, using chi-square, independent t-tests, and repeated measures analysis with p<0.05 as the criterion for significant differences. Results: The mean score of sedation was 4.82±0.49 in the DK group and 5.22±0.45 in the PF group [p value=0.001]. Serious complications, including hypotension [p value=0.005] and apnea [p value=0.10] were significantly higher in the PF group. Satisfaction of gastroenterologist [p value= 0.400] and patients’ pain score [p value = 0.900] were similar among groups. Conclusion: Combination of DK provides sufficient sedation with fewer complications in comparison with PF in colonoscopy patients.

scholarly journals The herbal combination of Sugarcane, Black Myrobalan, and mastic as a supplementary treatment for COVID-19: a randomized clinical trial

2021 ◽  
Author(s):  
Alireza Hashemi Shiri ◽  
Esmaeil Raiatdoost ◽  
Hamid Afkhami ◽  
Ruhollah Ravanshad ◽  
Seyed Ehsan Hosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Treatment Protocol ◽  
Vital Signs ◽  
Control Group ◽  
Event Analysis ◽  
Herbal Supplement ◽  
Significant Difference ◽  
And Control

AbstractBackgroundGiven the COVID-19 pandemic’s, researchers are beseeched for effective treatments. Herbal medicine is also queried for potential supplementary treatments for COVID-19. We aimed to evaluate the effects of Sugarcane, Black Myrobalan, and Mastic herbal medications for COVID-19 patients.MethodsThis was a double-blinded randomized clinical trial study conducted over three months from May to July 2020 in patients admitted with a diagnosis of COVID-19 in Peymaniyeh Hospital in Jahrom, Iran. The intervention group received the treatment protocol approved by the Ministry of Health of Iran during the period of hospitalization and the herbal supplement obtained from the combination of black myrobalan and mastic and sugarcane, twice a day (3g of herbal supplements). All patients were compared in terms of demographic variables, vital signs, clinical and laboratory variables.Results72 patients with COVID-19, divided into intervention (n=37) and control (n=35) groups. intervention and control groups had not any significant difference in terms of baseline characteristics. The time-to-event analysis revealed a significant difference in 4 symptoms of cough, fever, dyspnea, and myalgia (P<0.05). The Control group had a significantly lower decrease in C-reactive protein during 7 days (P<0.05). Patients in the herbal supplement group were hospitalized for 4.12 days and in the control group were hospitalized for 8.37 days (P=0.001). ICU admission and death only happened in 3 (8.6%) patients of the control group.ConclusionWhile advanced studies with more sample size are needed; the proposed combination seems to be effective in the symptom treatment and reducing the length of hospitalization.

scholarly journals Comparing the efficacy and safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for sedation in colonoscopy patients: A double-blinded randomized clinical trial

2021 ◽  
Author(s):  
Reza Aminnejad ◽  
Ahmad Hormati ◽  
Hamed Shafiee ◽  
Faezeh Alemi ◽  
Maryam Hormati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Score ◽  
Randomized Clinical Trial ◽  
Vital Signs ◽  
Repeated Measure ◽  
P Value ◽  
Chi Square ◽  
Measure Analysis ◽  
The Times ◽  
Double Blinded

Abstract BackgroundIn this double-blinded randomized clinical trial, we aimed to compare safety and efficacy of combination of dexmedetomidine and ketamine (DK) with propofol and fentanyl (PF) for sedation in colonoscopy patients.MethodsIn this study, 64 patients undergoing colonoscopy were randomized in two groups, A, receiving PF, and B receiving DK for sedation. Among 64 patients, 31 patients included in PF and 33 patients included in DK group. Both groups were similar in terms of demographics. Patients’ sedation score (based on Ramsy scale) and vital signs recorded at the times of 2, 5, 10 and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea and vomiting along with gastroenterologist satisfaction and patients’ pain score (based on Wong Baker faces pain assessment scale) recorded by a checklist. Data were analyzed by SPSS V.18, using chi-square, independent t-tests and repeated measure analysis with a p value < 0.05 significance level.ResultsThe mean score of sedation was 4.82 ± 0.49 in DK group and 5.22 ± 0.45 in PF group (p value = 0.001). Serious complications, including hypotension (p value = 0.005) and apnea (p value = 0.10) were significantly higher in PF group. Satisfaction of gastroenterologist (p value = 0.400) and patients’ pain score (p value = 0.900) were similar among groups.ConclusionCombination of DK provides sufficient sedation with less complications in compare with PF in colonoscopy patients.Trial registrationThe study protocol designed on the basis of Helsinki declaration for ethical consideration and was approved by the Ethics Committee of Qom University of Medical Sciences (ethics code: IR.MUQ.REC.1397.149); the study was also registered at the Iranian Center for Clinical Trials (No. IRCT20161205031252N11).

scholarly journals Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

2016 ◽  
Vol 8 (11) ◽  
pp. 178
Author(s):  
Soroush Amani ◽  
Ali Mohammadi-Najafabadi ◽  
Ali Ahmadi
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Acute Sinusitis ◽  
Chi Square ◽  
Significant Difference ◽  
Group 2 ◽  
Double Blinded ◽  
Minor Criteria

<p><strong>BACKGROUND:</strong> Regarding high prevalence of common cold and sinusitis in Chaharmahal and Bakhtiari Province and the lack of studies on patients referring hospitals in this province, this study was conducted to determine and compare the efficacy and side effects of azithromycin and co-amoxiclav.<strong></strong></p><p><strong>METHODS:</strong> This study was a double-blinded randomized clinical trial. The study population of this clinical trial was consisted of 90 patients with acute sinusitis aged 12-65 years. At least two major criteria or one major criterion and two minor criteria with duration of at least 7 days and at most 28 days, were some of the sinusitis diagnostic criteria for inclusion of the patients into the study. The patients were examined for symptoms prior to and twice after the treatment. The treatment was administration with <strong>500 mg</strong> azithromycin tablet per day for three days in group 1 (G1) and <strong>625 mg</strong> co-amoxiclav tablet every <strong>8 h</strong> for 10 days in group 2 (G2). The data were analyzed by repeated measures analysis of variance, independent t-test, and chi-square in Stata software and P &lt; 0.05 was considered significant.<strong></strong></p><p><strong>RESULTS: </strong>Mean±Standard deviation age of all patients was 32.14±9.91 years. Out of 90 participants in the study, 50 (55.56%) were male and the rest were female. The patients’ symptoms were quantitatively similar in the two groups (22.3±2 and 22.2±1.9 in G1 and G2, respectively) prior to the intervention. The score at second examination decreased to 3.7±2.1 in G1 and to 9.4±2.7 in G2, significantly different from that prior to intervention and between the two groups (P&lt;0.001). Although the score decreased in the two groups at third examination, it was not significant in the two groups (P=0.652). The cure rate in azithromycin group was derived 87.5% and 88%, and in co-amoxiclav group 32.4% and 83.3% at the days 5 and 10 of treatment, respectively. The most prevalent side effects in the two groups were diarrhea and nausea. The prevalence of diarrhea was obtained 21% and 33% in G1 and G2, respectively. </p><strong>CONCLUSION: </strong>No significant difference in side effects was seen between the two groups. Although the cure was faster in the patients treated with azithromycin than those treated with co-amoxiclav, co-amoxiclav is still considered as adequately working against acute sinusitis bacterial pathogens. In view of this efficacy, co-amoxiclav seems to lead to no drug resistance and could be used to treat the patient

Effects of Pistacia lentiscus and Coriander Triphala on Adult Gastroesophageal Reflux Disease: A Randomized Double-Blinded Clinical Trial

2020 ◽  
Vol 22 (6) ◽  
Author(s):  
Fariba Sadeghi ◽  
Seyed Mohammad Bagher Fazljou ◽  
Bita Sepehri ◽  
Laleh Khodaie ◽  
Hassan Monirifar
Keyword(s):  
Clinical Trial ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Randomized Clinical Trial ◽  
Reflux Disease ◽  
Pistacia Lentiscus ◽  
Significant Difference ◽  
Group B ◽  
In The Beginning ◽  
Double Blinded

Background: The cardinal symptoms of gastroesophageal reflux disease include heartburn (pyrosis) and regurgitation. Conventional treatment is done by proton pump inhibitors. In Persian traditional medicine, several herbs (single or combined) have been used to treat gastrointestinal disorders. Objectives: This study aimed to assess the effects of Pistacia lentiscus (mastic) and Coriander Triphala on reflux symptoms compared to omeprazole in a double-blinded randomized clinical trial. Methods: In a double-blinded, multicenter, randomized clinical trial, we assessed the effects of Pistacia lentiscus L., Coriander Triphala, and omeprazole on the symptoms of GERD in Tabriz, Iran, in 2018 - 2019. Thus, 105 patients with GERD symptoms were assigned randomly to three groups as group A (Pistacia lentiscus L., 1000 mg/TDS), group B (Coriander Triphala, 1000 mg/TDS), and group C (omeprazole, 20 mg/day plus five placebo capsules per day). The assessments were done at the beginning and the end of the study using FSSG, VAS, RS, and GERD-HRQL questionnaires. Results: In the beginning, no significant differences were observed between the groups in the background characteristics. There was no statistically significant difference between Pistacia lentiscus, Coriander Triphala, and omeprazole in the improvement of FSSG, VAS, GERD-HRQL, and reflux scores. In all groups, the FFSG, VAS, reflux, and GERD-HRQL scores significantly decreased and improved after four weeks of intervention compared to the respective baselines. The FSSG score improvements after four weeks of intervention were 73.68%, 83.33%, and 68.62%, in groups A, B, and C, respectively. The VAS score improvements were 66.66%, 75.00%, and 62.50% in groups A, B, and C, respectively. Improvements in GERD-HRQL were 90.00%, 91.28%, and 82.00%, in groups A, B, and C, respectively. Reflux improvements were 66.66%, 80.00%, and 66.66% in groups A, B, and C, respectively. Conclusions: The results showed that Pistacia lentiscus and Coriander Triphala are as effective as omeprazole in the treatment of GERD.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

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