scholarly journals Pilot Randomized Clinical Trial Study: Comparative Study of 10% Lidocaine Hydrochloride Solution with Lidocaine Prilocaine Emulsion Prior to Local Anesthetic Injection

2020 ◽  
Vol 13 (1) ◽  
pp. 47-51
Author(s):  
Naser Sargolzaei ◽  
Omid Rajabi ◽  
Yasaman Aleyasin ◽  
Kamran Ebrahimi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Local Anesthetic ◽  
Lidocaine Hydrochloride ◽  
Secondary Outcome ◽  
Age And Gender ◽  
Topical Anesthetics ◽  
Significant Difference ◽  
And Gender ◽  
Lidocaine Prilocaine

Background: The pain caused by the injection of local anesthetic has been reported as one of the main complaints of dental patients. Topical anesthetics are widely used drugs in dentistry, mainly to control pain associated with the needle penetration in the administration of local anesthesia. Objective: The present study aimed to evaluate (5%,7.5% and 10%) concentrations of lidocaine/prilocaine agent, compared to the common 10% lidocaine hydrochloride spray in the oral cavity. Materials and Methods: This was a split-mouth double-blind, randomized clinical trial pilot study. We randomized 15 patients, ages 35 to 64 years, with American Society of Anesthesiologists I and II with severe chronic periodontitis who were referred to the dental clinic for surgery, to receive 4 topical anesthetics (5%, 7.5%, and 10%) lidocaine prilocaine emulsion and 10% lidocaine hydrochloride topical anesthetic agent before local infiltration. Primary outcomes were assessing drug safety and pain level that measured by assessment of visual analog scale (VAS) scores of pain during LA injection in the first premolar and second molar in each maxillary quadrant in 15 patients corresponding to the posterior superior alveolar nerve (PSA) and secondary outcome was the relationship between age and gender regarding pain perception, and a total of 60 regions were analyzed. Results: Results revealed that there was no statistically significant difference between lidocaine hydrochloride and (5%,7.5% and 10%) lidocaine prilocaine in terms of pain reduction when the 4 different compounds were compared. According to Spearman's rank correlation coefficient and Friedman test, the age and gender of the patients had an insignificant correlation with the anesthetic effects of the four studied solutions. Conclusion: Based on these results, age and gender have insignificant effects on the pain scores and it can be said that the four solutions do not have significant differences regarding their anesthetic effects; also, we did not find any adverse reactions by using 7.5% and 10% lidocaine/prilocaine agent.

scholarly journals The effectiveness of online metacognitive versus face-to-face counseling on anxiety and metaworry in women with a history of spontaneous miscarriage: A Randomized clinical trial

2020 ◽  
Author(s):  
Mina Ghiasi shaham Abadi ◽  
Tahmineh Farajkhoda ◽  
Hassan Zareei Mahmoodabadi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Secondary Outcome ◽  
Base Line ◽  
Satisfaction Scale ◽  
Face To Face ◽  
Group I ◽  
Significant Difference ◽  
History Of ◽  
Online Group

Abstract BackgroundOnline and face-to-face counseling interventions can be performed on women with a history of miscarriage, which causes their anxiety and metaworry.The aim of this study was to compare effectiveness of metacognitive counseling methods, online and face-to-face, on anxiety and metaworry of women with miscarriage.MethodsIn this parallel randomized clinical trial, 40 women with a history of miscarriage, anxiety and metaworry were randomly assigned to two groups (n = 20/each): group I receiving metacognitive counseling via online network and software, and group II (control) receiving face-to-face metacognitive counseling with same content and time, 90-minute sessions. Data were collected demographic form, Beck Anxiety Inventory, Wellz metaworry questionnaire and satisfaction scale. Primary outcomes included changes in the scores of anxiety, metaworry were measured in both groups in three times including at the base line, and at the end of week eight and twelve of the intervention initiation. Satisfaction with counseling method was assessed as secondary outcome at the end of week eight and twelve of the intervention beginning in both groups.ResultsIn both groups, mean score of anxiety in 12th week was significantly different from before the intervention; difference was more significant in online group (p = 0.04). In both groups, the mean score of metaworry in 12th week had a statistically significant difference compared to the beginning of the study, and the decrease was again more significant in the online group (p = 0.03). Satisfaction with the counseling method had statistically significant difference between the two groups in week eight and twelve (respectively p ≈ 0.00).ConclusionsMetacognitive counseling both online and face-to-face improves anxiety and metaworry in women with miscarriage. Online counseling was more effective, satisfying, and longer compared with face-to-face counseling method, especially in corona virus19 outbreak.Trial registration: ISRCTN, IRCT20181120041707N1, Prospectively registered, Registered 23 May 2019, https://en.irct.ir/trial/35643/ IRCT20181120041707N1

scholarly journals Comparison of the effect of oral diphenhydramine and midazolam on sedation of children

2021 ◽  
Vol 7 (4) ◽  
Keyword(s):  
Clinical Trial ◽  
Diagnostic Procedure ◽  
Bitter Taste ◽  
Vital Signs ◽  
Information Sheet ◽  
Age And Gender ◽  
Significant Difference ◽  
The Mean ◽  
And Gender ◽  
Effective Sedation

Objectives: The aim of this study was to compare the effect of diphenhydramine and midazolam on sedation of children. Methods: This clinical trial was performed on children aged 1 to 7 years who referred to the emergency department for diagnostic radiology. Patients were randomly divided into two groups of midazolam and diphenhydramine. Then, 30 minutes before the start of the procedure, 0.5 mg /kg was given to the midazolam group and 0.5 cc /kg to the diphenhydramine group. If sedation occurred, the child was separated from the parents and transferred to a diagnostic procedure. After performing the intended diagnostic procedure, the information sheet was completed and the patient's vital signs were checked again. The data were then analyzed by SPSS version 19 software. Results: A total of 74 patients were included in the study. There was no significant difference between the two groups in terms of age and gender (P = 0.89; P = 0.32). The mean sedation in the midazolam and diphenhydramine groups was 1.02 and 1.59 years, respectively. A significant difference was found between the two groups in terms of sedation (P = 0.04), where a greater effect of diphenhydramine on sedation was observed. Conclusion: The findings showed that the use of diphenhydramine resulted in effective sedation for children. Due to the fact that the main problem with midazolam is its bitter taste, which makes children reluctant to eat it, the use of diphenhydramine can be recommended.

The Influence of Age and Gender on Mandibular Indices among the Libyan Population

2019 ◽  
Vol 3 (2) ◽  
Keyword(s):  
Negative Correlation ◽  
Bone Mineralization ◽  
Age Groups ◽  
T Test ◽  
Chi Square ◽  
Age And Gender ◽  
Significant Difference ◽  
Chi Square Test ◽  
And Gender ◽  
Libyan Population

Radiographic Mandibular Indices serve as easy and relatively cheap tools for evaluating bone mineralization. Objectives: To examine the effect of age and gender on three mandibular indices: the panoramic mandibular index (PMI), the mandibular ratio (MR) and the mandibular cortical index (MCI), among Libyan population. Methods: The three indices were measured on 317 digital (OPGs) of adult humans (155 males, 162 females). The sample was divided into six age groups (from 18-25 years through 56-65 years). The measurements were analyzed for interactions with age and sex, using SPSS (Statistical Package for Social Studies) software version no. 22. The tests employed were two way ANOVA, the unpaired T-test and chi-square test. Results: The mean PMI fluctuated between 0.37 s.d. 0.012 and 0.38 s.d. 0.012. among the sixth age groups. One-way ANOVA statistical test revealed no significant of age on PMI. On the other hand gender variation has effect on PMI, since independent sample t-test disclosed that the difference between the male and female PMI means statistically significant. ANOVA test showed that the means of MR among age groups showed a negative correlation i.e. MR mean declined from 3.01 in 18-25 age groups to 2.7 in 55-65 age groups. In contrary, the gender showed no effect on MR according two sample t-test at p> 0.05. In regards with MCI, statistical analysis showed that it affected by age that is C1 was decreasing by age while C2 and C3 were increased by age. Using chi square test the result indicated that there is a significant difference among the different age group and the two genders in MCI readings. Conclusion: PMI was influenced significantly by age but minimally by the gender. MR is not affected by gender but has a negative correlation with age. MCI is affected by both age and gender

Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

2015 ◽  
pp. 214-228 ◽  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Health Care Providers ◽  
Developmental Disorders ◽  
Attention Problems ◽  
Secondary Outcome ◽  
Care Providers ◽  
Treatment Trial ◽  
Additional Hypothesis ◽  
Convergence Insufficiency

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

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.

scholarly journals A Study of Wideband Energy Reflectance in Patients with Otosclerosis: Data from a Chinese Population

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Suju Wang ◽  
Wenyang Hao ◽  
Chunxiao Xu ◽  
Daofeng Ni ◽  
Zhiqiang Gao ◽  
...  
Keyword(s):  
Resonance Frequency ◽  
Racial Differences ◽  
Chinese Population ◽  
Ambient Pressure ◽  
Control Group ◽  
Age And Gender ◽  
Significant Difference ◽  
And Gender ◽  
And Control ◽  
Peak Pressures

Objective(s). The purpose of this study was to explore the effectiveness of wideband acoustic immittance (WAI) in the diagnosis of otosclerosis by comparing the differences in the energy reflectance (ER) of WAI between patients with otosclerosis and age- and gender-matched normal hearing controls in the Chinese population. Methods. Twenty surgically confirmed otosclerotic ears were included in the otosclerotic group. The ER of WAI at ambient and peak pressures, resonance frequency, and 226-Hz tympanogram were collected prior to surgery using a Titan hearing test platform (Interacoustics A/S, Middelfart, Denmark). All diagnoses of otosclerosis in the tested ear were confirmed by surgery after the measurements. Thirteen normal adults (26 ears) who were age- and gender-matched with the otosclerotic patients were included as the control group. Results. At peak pressure, the ERs of otosclerotic patients were higher than those of the control group for frequencies less than 4,000Hz and were lower for frequencies greater than 4,000Hz. In addition, within the analyzed frequencies, the differences observed at 2,520Hz was statistically significant (p<0.05/16=0.003, Bonferroni corrected). At ambient pressure, the differences observed at 1,260 and 6,350Hz were statistically significant (p<0.05/16=0.003, Bonferroni corrected). Although the differences between the otosclerotic and control groups exhibited similar trends to those in studies implemented in Caucasian populations, the norms in the present study in the control group were different from those in the Caucasian populations, suggesting racial differences in WAI test results. Regarding the middle ear resonance frequency, no significant difference was observed between the two groups (P>0.05). Conclusion. WAI can provide valuable information for the diagnosis of otosclerosis in the Chinese population. Norms and diagnostic criteria corresponding to the patient’s racial group are necessary to improve the efficiency of WAI in the diagnosis of otosclerosis.

Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Jéssica A. Moratelli ◽  
Kettlyn H. Alexandre ◽  
Leonessa Boing ◽  
Alessandra Swarowsky ◽  
Clynton L. Corrêa ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Freezing Of Gait ◽  
Motor Symptoms ◽  
Score Change ◽  
Significant Difference ◽  
Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

Hair Magnesium content and its relation to Serum Magnesium level in children with Idiopathic Epilepsy

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hamed Mahmoud Shatla ◽  
Mariam Fathy Abdel Maksoud ◽  
Raghda Mohamed Hesham Zaitoun ◽  
Alaa Rabie Abdel Baset Mahmoud
Keyword(s):  
Serum Magnesium ◽  
Serum Levels ◽  
Magnesium Content ◽  
Magnesium Level ◽  
Idiopathic Epilepsy ◽  
Age And Gender ◽  
Control Subjects ◽  
Significant Difference ◽  
And Gender ◽  
Patients With Epilepsy

Abstract Objective To measure the level of hair Mg, as well as its level in serum, in patients with epilepsy and compare them to the levels found in non-epileptic age and gender matched children, and to explore any potential correlation between either serum or hair level of magnesium and seizure characteristics in children with idiopathic epilepsy. Methods An observational cross-sectional study including 50 children with idiopathic epilepsy and 100 non-epileptic age and gender matched control subjects. Cases were subjected to full history taking, examination and measurements of serum and hair levels of magnesium, control subjects only had their serum and hair level of magnesium measured as for the cases. Results The mean serum magnesium was 29.11 ± 13.42 ug/ml for cases and 27.67 ± 7.24 ug/ml for controls and the median hair level of magnesium was 42.22 ug/g with IQR of 25.9 - 56.82 for cases and 38.6 ug/g with IQR of 25.21 - 61.25 for controls. No statistically significant difference was observed between both groups as regards either serum or hair magnesium levels. No statistically significant correlation was observed between either hair or serum levels of magnesium and seizure characteristics though the correlations were nearing statistical significance for the hair magnesium content. Conclusion Hair magnesium level may be better correlated to seizure characteristics and control than serum levels in patients with epilepsy.

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