Effectiveness, Safety, and Satisfaction of Silicone Pro Gel in Prophylaxis and Management of Post-Operative Scar: A Randomized, Double-Blinded, Placebo-Controlled Study

2020 ◽  
Vol 103 (5) ◽  
pp. 442-448
Keyword(s):  
Side Effects ◽  
Cesarean Section ◽  
Study Drug ◽  
Controlled Study ◽  
Abdominal Wound ◽  
Study Product ◽  
High Satisfaction ◽  
Double Blinded ◽  
Better Than ◽  
Surface Regularity

Objective: To assess the effectiveness and side effects of Silicone Pro Gel to alleviate scar development among the pregnant women with the first cesarean section, and their satisfaction. Materials and Methods: The present study was a randomized, double-blinded, placebo-controlled study among the women with transverse abdominal wound of the first cesarean section. The formation and improvement of scar was assessed by interventionblinded investigators and patients in terms of redness, height, surface regularity, and attribute of the scar. Ninety women were enrolled into either the study drug or placebo groups by computerized randomization (C0). Women in both groups applied the allocated drugs within 7 to 10 days after cesarean section and had to apply the allocated drugs twice a day. The re-assessment was done at 28±4 days (C1), at 56±4 days (C2) and at 84±4 days (C3). Results: About 76% of women completed the study. The present study product performed better than the placebo in terms of formation of the wound, including height, surface regularity, and attribute of the scar. Neither side effects nor serious complications caused by the study drug were reported. Most women reported high satisfaction and there was no difference of participants’ perception toward the wound between groups. Conclusion: Silicone Pro Gel performed better in terms of alleviation of scar development post cesarean section with high participants’ satisfaction. Keywords: Scar, Photograph assessment, Investigator, Participant

Comparison of the Effects of Inhaled SCH 1000 and Fenoterol on Exercise-Induced Bronchospasm in Children

PEDIATRICS ◽  
1980 ◽  
Vol 66 (1) ◽  
pp. 109-114
Author(s):  
R. Yeung ◽  
G. M. Nolan ◽  
H. Levison
Keyword(s):  
Side Effects ◽  
Pulmonary Function ◽  
Controlled Study ◽  
Anticholinergic Drugs ◽  
Base Line ◽  
Anticholinergic Agent ◽  
Asthmatic Children ◽  
Before And After ◽  
Exercise Induced ◽  
Better Than

The effect of 40 µg of SCH 1000 (ipratropium bromide, an anticholinergic agent) on bronchodilation and suppression of exercise-induced bronchospasm (EIB) was compared with 400 µg of fenoterol and a placebo in a single-blind controlled study. Twenty-seven randomly selected asthmatic children performed a standardized treadmill exercise challenge and the 17 children who were shown to have EIB continued in the study. Pulmonary function was evaluated before and after drug administration and exercise. When individual results were analyzed and grouped according to the responsiveness of EIB to the drugs, two patterns emerged: (1) the EIB was more severe in those (6/17) children who did not respond to either drug than in the rest of the children; (2) the resting pulmonary function was significantly better in the children (4/17) who responded to both drugs than in those (7/17) who responded to fenoterol alone. In conclusion SCH 1000 was shown to be an effective bronchodilator comparable to, but no better than, fenoterol. It had minimal side effects. As an EIB inhibitor it depended on relatively normal base line pulmonary function and only a moderate deterioration following exercise, whereas fenoterol depended on the exercise response alone. Although anticholinergic drugs are not very extensively used, SCH 1000 may be useful in some patients where the β2 adrenergic drugs cause significant side effects or are contraindicated.

scholarly journals The relationship between core temperature and perioperative shivering during caesarean section under intrathecal anesthesia with bupivacaine and ropivacaine: a randomized controlled study

2021 ◽  
Author(s):  
Guangju Feng ◽  
Yu Wang ◽  
Jiehua Feng ◽  
Xiaomin Luo ◽  
Chaoyang Li ◽  
...  
Keyword(s):  
Caesarean Section ◽  
Cesarean Section ◽  
Core Temperature ◽  
Elective Caesarean Section ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Group B ◽  
Double Blinded ◽  
Combined Spinal Epidural Anesthesia ◽  
Spinal Epidural

Abstract Purpose To assess the incidence rate of perioperative shivering for cesarean section and explore the associations between the occurrence of shivering and hypothermia, core temperature change, local anesthetic. Methods This is a prospective, randomized, controlled, double-blinded study of 100 patients consenting for caesarean section under intrathecal anesthesia. Parturients with ASA I or II accepted elective caesarean section with combined spinal-epidural anesthesia (SA). 2–2.5 ml of 0.5% bupivacaine or 0.5% ropivacaine was intrathecally injected in group B and group R, respectively. Results The intraoperative shivering incidence in group B was significantly higher than that in group R (66.7 vs. 20.5%, Pvalue < 0.001), and shivering intensity in group B was significantly greater than group R (score: 1.4 vs. 0.3, Pvalue < 0.001). The core temperature in both groups gradually decreased with the time after SA. Hypothermia (core temperature < 36.0 ℃) 5–30 min after SA was not associated with shivering. However, changes of temperature at 25 and 30 min after SA, and bupivacaine were statistically associated with shivering, with the odds of 10.77 (95% CI: 1.36–85.21, P value = 0.02), 8.88 (95% CI: 1.29–60.97, P value = 0.03), and 7.78 (95% CI: 2.94–20.59, P value < 0.01), respectively. Conclusions In our study, for cesarean section, the occurrence of shivering was associated with the local anesthetics and the change of core temperature after SA, while not the hypothermia.

scholarly journals Improvement of urinary tract symptoms and quality of life in Benign Prostate Hyperplasia patients, associated with consumption of a newly developed whole tomato-based food supplement. A phase II prospective, randomized double-blinded, placebo-controlled study.

2020 ◽  
Author(s):  
Luigi Cormio ◽  
Beppe Calò ◽  
Ugo Falagario ◽  
Manuela Iezzi ◽  
Alessia Lamolinara ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Tract ◽  
Side Effects ◽  
Phase Ii ◽  
Food Supplement ◽  
Controlled Study ◽  
Urinary Tract Symptoms ◽  
Group B ◽  
Double Blinded

Abstract Background: Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients’ quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH.Methods: Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for two months a sachet (5 grams) of a newly developed whole tomato food supplement (WTFS) (treatment=Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score questionnaire before and after treatment.Results: All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (p<0.0002) LUTS since mean IPSS decreased from 9.05+1.15 SE to 7.15+1.04 SD (paired t-test, two-tailed p-value <0.001), and improved life quality (P < 0.0001) A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/ml+1.52 SE vs 6.95+0.76 SE, P = 0.065), with changes being statistical significant only in the subgroup of patients with baseline levels above 10 ng/ml (18.5ng/ml+2.7vs. 10.3+2.1p= 0.009)Conclusions: The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients

Amelioration of Levetiracetam- induced behavioral side effects by Pyridoxine-Randomized double blinded controlled study

2021 ◽  
Author(s):  
Adel Mahmoud ◽  
Sadia Tabassum ◽  
Shoaa Al Enazi ◽  
Nahed Lubbad ◽  
Ali Al Wadei ◽  
...  
Keyword(s):  
Side Effects ◽  
Controlled Study ◽  
Double Blinded

A Comparison of Intrathecal Fentanyl and Sufentanil for Labor Analgesia

2002 ◽  
Vol 96 (5) ◽  
pp. 1070-1073 ◽  
Author(s):  
Kenneth E. Nelson ◽  
Traci Rauch ◽  
Victor Terebuh ◽  
Robert D'Angelo
Keyword(s):  
Side Effects ◽  
Study Design ◽  
Mode Of Delivery ◽  
Study Drug ◽  
Labor Analgesia ◽  
Spinal Analgesia ◽  
Potency Ratio ◽  
Dosing Error ◽  
Nulliparous Women ◽  
Double Blinded

Background The use of intrathecal opioids for labor analgesia continues to gain popularity, but there are limited data to guide this use. Previously, the authors established the ED50 for 60 min of labor analgesia from intrathecal sufentanil using an up-down sequential allocation study design. The current study first establishes an ED50 for intrathecal fentanyl using this same study design to establish an intrathecal potency ratio for fentanyl and sufentanil and then uses this ratio to compare the efficacy, duration of analgesia, and side effects from comparable doses of intrathecal fentanyl and sufentanil. Methods Seventy-five healthy nulliparous women requesting labor analgesia were enrolled in this two-part study. In phase I, 20 women received varying doses of fentanyl to establish an ED50 for 60 min of labor analgesia. In phase II, 55 women were randomized to receive either 36 microg intrathecal fentanyl or 8 microg sufentanil (2 times the ED50s) via a combined spinal-epidural technique and by double-blinded design. Pain relief, side effects, block height, maternal hemodynamics, and fetal heart rate were assessed throughout the study. The duration of spinal analgesia was considered to be the time from injection of study drug to the time of the patient's first request for additional analgesia. Results The ED50 of intrathecal fentanyl for 60 min of labor analgesia was found to be 18.2 microg, and therefore, the potency ratio of intrathecal sufentanil to intrathecal fentanyl at the ED50 level is 4.4:1. The duration of spinal analgesia was significantly longer from 8 microg intrathecal sufentanil than from 36 microg intrathecal fentanyl (104 +/- 34 vs. 79 +/- 34 min, P = 0.009). Otherwise, patient demographics, maternal hemodynamics, duration of labor, mode of delivery, motor block, subjective leg weakness, pruritus, nausea, pinprick sensory levels, visual analog scale pain scores, fetal bradycardia, and Apgar scores were similar between groups. Conclusion The relative potency of intrathecal sufentanil to fentanyl for labor analgesia is 4.4:1. When using intrathecal opioids alone for early labor analgesia, 8 microg sufentanil produces labor analgesia lasting approximately 25 min longer than from 36 microg fentanyl, without a statistically significant increase in side effects. However, when making a choice between fentanyl and sufentanil, one must consider other important factors, such as the higher cost of sufentanil and the greater risk of dosing error due to the higher potency of sufentanil compared with fentanyl.

scholarly journals Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Luigi Cormio ◽  
Beppe Calò ◽  
Ugo Falagario ◽  
Manuela Iezzi ◽  
Alessia Lamolinara ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Tract ◽  
Side Effects ◽  
Phase Ii ◽  
Food Supplement ◽  
Controlled Study ◽  
Urinary Tract Symptoms ◽  
Group B ◽  
Double Blinded

Abstract Background Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients’ quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH. Methods Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment. Results All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009). Conclusions The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.

Pre-operative tranexemic acid vs. etamsylate in reducing blood loss during elective cesarean section: randomized controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Haitham Torky ◽  
El-Sayed El-Desouky ◽  
Ibrahim Abo-Elmagd ◽  
Attia Mohamed ◽  
Ahmad Abdalhamid ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Blood Loss ◽  
Cesarean Section ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Elective Cesarean Section ◽  
Randomized Controlled ◽  
Elective Cesarean ◽  
Double Blinded

AbstractObjectivesTo investigate whether etamsylate may be an alternative to tranexamic acid in reduction of blood loss during elective cesarean section.MethodsProspective double-blinded multi-center randomized controlled trial involving 180 qualified women equally divided into three groups each containing 60 women received either tranexamic acid, etamsylate or placebo 20 min before elective cesarean section and blood loss was estimated.ResultsMean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.ConclusionsEtamsylate is an effective second-line therapy (after tranexamic acid) in reducing blood loss during elective cesarean section with low risk of side effects, therefore, it can be an effective alternative to tranexamic acid in cases with contraindications or anticipated to be at high-risk of developing side effects from tranexamic acid.

scholarly journals A Comparative Study of Ramosetron and Lidocaine in the Attenuation of Propofol Induced Pain in Paediatric Patients – A Double Blinded Randomized Study in ESIC Medical College, Kalaburgi

2021 ◽  
Vol 8 (25) ◽  
pp. 2132-2137
Author(s):  
Sumalatha Gangur Basappa ◽  
Ravichandra Ramesh Dodawad
Keyword(s):  
Randomized Study ◽  
Study Drug ◽  
Venous Drainage ◽  
Controlled Study ◽  
Injection Pain ◽  
P Value ◽  
Chi Square ◽  
Exact Test ◽  
Elective Surgical Procedures ◽  
Double Blinded

BACKGROUND The incidence of pain on propofol injection varies between 28 – 90 % during induction and may be severe. Ramosetron has been proved efficacious in reducing propofol pain in adults but not in children, therefore we conducted this double blinded randomized controlled study to determine the effectiveness of ramosetron in attenuating propofol induced pain in children. The purpose of this study was to compare the effectiveness of injection ramosetron, a 5HT3 antagonist and lidocaine, the commonest drug for attenuation of pain caused by injection propofol. METHODS This is a randomised double-blinded study. Eighty children of American Society of Anaesthesiologist (ASA) grade I - II, aged 4 - 14 years, undergoing elective surgical procedures under general anaesthesia were randomly assigned to two groups of 40 each. Group PR received 6 µg/kg of ramosetron and Group PL received 0.2 mg/kg of 2 % lidocaine. After injection of study drug, occlusion of venous drainage was done manually by a trained assistant at mid-arm for 60 seconds. After releasing manual occlusion Injection propofol (1 %) 2 mg/kg was administered slowly over a period of 5 seconds. A four point scale was used to assess the severity of pain. The results were analysed by using unpaired student’s t - test and chi-square test/Fisher’s exact test. P value of < 0.05 was considered statistically significant. RESULTS The demographic characteristics were comparable in both groups. The incidence of no pain in Group PR and Group PL was 60 % (N = 24) and 65 % (N = 26) respectively which was comparable. The incidence of mild, moderate and severe pain was comparable in both groups. The overall incidence of propofol injection pain in group PL and group PR was 35 % and 40 % respectively (P = 0.862). CONCLUSIONS Intravenous ramosetron at a dose of 6 µg/kg can effectively attenuate the propofol induced pain comparable to 0.2 mg/kg of lidocaine in children. KEYWORDS Children, Lidocaine, Propofol Induced Pain, Ramosetron

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