scholarly journals Dexamethasone for Morbidity After Subdural Electrode Insertion – A Randomized Controlled Trial

2003 ◽  
Vol 30 (4) ◽  
pp. 340-348 ◽  
Author(s):  
Ramesh L. Sahjpaul ◽  
Jeff Mahon ◽  
Samuel Wiebe
Keyword(s):  
Pain Relief ◽  
Postoperative Period ◽  
Controlled Trial ◽  
Intractable Epilepsy ◽  
Controlled Clinical Trial ◽  
Antiemetic Drug ◽  
Double Blind ◽  
Dexamethasone Group ◽  
Significant Difference ◽  
Limited Duration

Background:Invasive monitoring with subdural electrodes (SDE) for investigation of medically intractable epilepsy may be associated with undesirable immediate postoperative morbidity such as headache, nausea, vomiting, fever, and meningism. We undertook to evaluate the potential beneficial role of perioperative dexamethasone in reducing these symptoms.Methods:In a double-blind placebo controlled clinical trial 30 patients undergoing SDE insertion were randomized to receive either placebo or a course of dexamethasone beginning one hour prior to surgery and tapering to discontinue over 72 hours postoperatively. Pain, pain relief, nausea, nausea relief, temperature, and meningism were assessed regularly in the postoperative period, and analgesic, antipyretic, and antiemetic drug requirements were tabulated.Results:One patient was withdrawn from the dexamethasone group due to lack of data. With regards to postoperative pain, the direction of benefit favoured dexamethasone but a significant treatment by time interaction prevented further analysis of treatment effect. The dexamethasone group did have significantly lower temperatures and higher nausea relief scores. There was no statistically significant difference between the groups with regards to pain relief, nausea, and meningism scores. The beneficial effects of dexamethasone were delayed in onset, of limited duration, and not uniform over the observation period.Conclusion:Dexamethasone appears to have a role in reducing immediate morbidity following SDE insertion but its effect is not uniform in the postoperative period; it appears to be delayed in onset, and of limited duration. Further study is necessary to determine the ideal dosing schedule.

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

A randomized, controlled clinical trial of ketoprofen for sickle-cell disease vaso-occlusive crises in adults

Blood ◽  
2009 ◽  
Vol 114 (18) ◽  
pp. 3742-3747 ◽  
Author(s):  
Pablo Bartolucci ◽  
Tony El Murr ◽  
Françoise Roudot-Thoraval ◽  
Anoosha Habibi ◽  
Aline Santin ◽  
...  
Keyword(s):  
Pain Relief ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Controlled Clinical Trial ◽  
Cell Disease ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
End Points

Abstract Vaso-occlusive crisis (VOC) is the primary cause of hospitalization of patients with sickle-cell disease. Treatment mainly consists of intravenous morphine, which has many dose-related side effects. Nonsteroidal antiinflammatory drugs have been proposed to provide pain relief and decrease the need for opioids. Nevertheless, only a few underpowered trials of nonsteroidal antiinflammatory drugs for sickle-cell VOC have been conducted, and conflicting results were reported. We conducted a phase 3, double-blind, randomized, placebo-controlled trial with ketoprofen (300 mg/day for 5 days), a nonselective cyclooxygenase inhibitor, for severe VOC in adults. A total of 66 VOC episodes were included. The primary efficacy outcome was VOC duration. The secondary end points were morphine consumption, pain relief, and treatment failure. Seven VOC episodes in each group were excluded from the analysis because of treatment failures. No significant between-group differences were observed for the primary outcome or the secondary end points. Thus, although ketoprofen was well-tolerated, it had no significant efficacy as treatment of VOC requiring hospitalization. These findings argue against its systematic use in this setting.

Intravenous Tranexamic Acid for Subdural and Epidural Intracranial Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

2019 ◽  
Vol 14 (4) ◽  
pp. 286-291 ◽  
Author(s):  
Pouya Ebrahimi ◽  
Javad Mozafari ◽  
Reza Bahrami Ilkhchi ◽  
Mohammad Ghasem Hanafi ◽  
Maryam Mousavinejad
Keyword(s):  
Tranexamic Acid ◽  
Intracranial Hemorrhage ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Subdural Hemorrhage ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Epidural Hemorrhage ◽  
And Control

Background: Recovery of patients with traumatic brain injury largely depends on the reduction in secondary brain damage. The present study aims at investigating the effect of Tranexamic Acid (TXA) administration within the first hours of brain trauma in the emergency department (ED). Methods: This randomized, double-blind, placebo-controlled clinical trial was carried out in patients with subdural and epidural hemorrhage. Patients with any type of bleeding were assigned into two groups of TXA and 0.9% normal saline as placebo. The rate of intracranial hemorrhage after surgery was assessed by CT-scan and amount of hemoglobin (Hb) was measured immediately before surgery and after 6 hours of surgery. Results: A total of 80 participants were randomly assigned into four groups of 20 people. There was a significant difference in the mean of intraoperative bleeding during surgery in patients receiving TXA and placebo in both SDH (Subdural hematoma) and EDH (Epidural Hemorrhage) groups (P= 0.012). The Hb drop amount had no significant difference with placebo (P< 0.0001). No complications were observed in any of the intervention and control groups during the study as well. Conclusion: The use of TXA may reduce bleeding, however, based on the results of this study, such effect was not statistically significant in controlling the epidural and subdural hemorrhage, but clinical trials with a higher sample size are suggested for further investigation in this regard.

scholarly journals Analgesic Effect of Perioperative Duloxetine in Patients After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Mingcheng Yuan ◽  
Tingting Tang ◽  
Zichuan Ding ◽  
Hao Li ◽  
Zongke Zhou
Keyword(s):  
Total Knee Arthroplasty ◽  
Placebo Group ◽  
Knee Arthroplasty ◽  
Postoperative Period ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Double Blind ◽  
Management Protocol ◽  
Significant Difference ◽  
Total Knee

Abstract Background: To investigate the analgesic effect of perioperative use of duloxetine in patients received total knee arthroplasty (TKA). Method: The hospital pharmacy prepared small capsules containing either duloxetine or starch (placebo) which were all identical in appearance and weight (1:1). Enrolled patients were given a capsule (containing either 60 mg duloxetine or 60 mg placebo) every night before sleep since preoperative day 2 till postoperative day 14 (17 days in all) by a nurse who were not involved in this trial. Other perioperative managements were the same in the two groups. The primary outcome was the VAS score (both rVAS and aVAS) throughout the perioperative period. The secondary outcomes included opioid consumption, range of motion, including both active ROM (aROM) and passive ROM (pROM) and adverse events. Result: rVAS in duloxetine group were significantly less than placebo group throughout the postoperative period (From postoperative 2 hours to postoperative 3 months) (P<0.05). In terms of aVAS, similarly, duloxetine group had less aVAS than placebo group throughout the postoperative period (From postoperative 6 hours to postoperative 3 months) (P<0.05). During the postoperative period (From postoperative day 1 to 7), patients in duloxetine group consumed significantly less opioids per day than the placebo group (P<0.05). aROM in duloxetine group were significantly better than placebo group from postoperative 6 hours to postoperative day 5 (P<0.05), since postoperative day 6, the aROM became comparable between the two groups (P>0.05). In terms of pROM, duloxetine group had significantly better pROM from postoperative 6 hours to postoperative day 4 (P<0.05), thereafter, the pROM between the two groups became comparable (P>0.05). No significant difference was found between the two groups in the rates of dizziness, bleeding, sweating, fatigue and dryness of mouth. In the placebo group, more patients got nausea/vomiting and constipation (P<0.05). However, in terms of drowsiness, duloxetine group was reported higher rate (P<0.05). Conclusion: Duloxetine could reduce acute postoperative pain and decrease the opioids consumption as well as accelerating postoperative recovery, without increasing the risk of adverse medication effects in patients undergoing TKA. Duloxetine could act as a good supplement in multimodal pain management protocol for patients undergoing TKA. Trial registration statement: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2000033910). The date of registration was 06/16/2020.

scholarly journals Double-blind, crossover, placebo-controlled clinical trial with clobetasol propionate in desquamative gingivitis

2009 ◽  
Vol 20 (3) ◽  
pp. 231-236 ◽  
Author(s):  
Ana Carolina Fragoso Motta ◽  
Carina Domaneschi ◽  
Marilena Chinali Komesu ◽  
Cacilda da Silva Souza ◽  
Valéria Aoki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Clobetasol Propionate ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Significant Difference

The aim of this study was to evaluate the efficacy of a 0.05% clobetasol propionate ointment administered in trays to 22 patients with desquamative gingivitis in a double-blind, crossover, placebo-controlled trial. Patients received container number 1 and were instructed to apply the ointment 3 times a day for 2 weeks, and to reduce the application to once a day in the third week. Next, the patients were then instructed to discontinue the treatment for 2 weeks, and were then given container 2, used in the same way and for the same length of time as container 1. Regarding signs, 17 patients presented some improvement, while 5 experienced worsening with clobetasol propionate. With the placebo, 14 patients presented some improvement, and 8 patients presented worsening. For symptoms, there was complete improvement in 2 patients, partial improvement in 12, no response in 7, and worsening in 1 with clobetasol propionate. With the placebo, there was partial improvement in 8 patients, no response in 12 and worsening in 2. No statistically significant difference was found between clobetasol and placebo (p>0.05). Within the period designed to treat the gingival lesions of the patients, clobetasol propionate did not significantly outperform the placebo.

Homeopathic treatment of migraine: A double blind, placebo controlled trial of 68 patients

2000 ◽  
Vol 89 (01) ◽  
pp. 4-7 ◽  
Author(s):  
P Straumsheim ◽  
C Borchgrevink ◽  
P Mowinckel ◽  
H Kierulf ◽  
O Hafslund
Keyword(s):  
Pain Intensity ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Attack Frequency ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Homeopathic Treatment ◽  
Registration Period ◽  
Significant Difference ◽  
Accompanying Symptoms

AbstractTo evaluate the efficacy of homeopathy in preventing migraine attacks and accompanying symptoms, a randomised, double-blind, placebo-controlled clinical trial was conducted. There was a one-month registration period without treatment, followed by four months individualised homeopathic treatment or identical placebo. Patients were stratified for common or classical migraine.Seventy-three patients were randomised, 68 completed the trial. Baseline values were similar in the two groups. Both the homeopathy and placebo groups had reduction in attack frequency, pain intensity and drug consumption, with a statistically non-significant difference favouring homeopathy. Migraine diaries showed no difference between groups. The neurologists’ trial evaluation showed a statistically significant reduction in attack frequency in the homeopathy group (P=0.04) and non-statistically significant trends in favour of homeopathy for pain intensity and overall evaluation.Further research, with improved trial design, on the possible role of homeopathy in migraine prophylaxis is justified.

scholarly journals Efficacy of Ginger in Ameliorating Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Among Patients With Lung Cancer Receiving Cisplatin-Based Regimens: A Randomized Controlled Trial

2018 ◽  
Vol 17 (3) ◽  
pp. 747-754 ◽  
Author(s):  
Xiangfeng Li ◽  
Ying Qin ◽  
Wei Liu ◽  
Xiao-yu Zhou ◽  
Ya-nan Li ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Patient Adherence ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Antiemetic Therapy ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Delayed Nausea

Nausea and vomiting are among the most common and distressing side effects of chemotherapy. Additional antiemetic drugs are urgently needed to effectively manage and ameliorate chemotherapy-induced nausea and vomiting (CINV). The efficacy of ginger as an antiemetic modality for ameliorating CINV has not been established in previous studies. The aim of this study was to examine the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. In this randomized, double-blind, placebo-controlled clinical trial, 140 patients with lung cancer receiving cisplatin-based regimens were enrolled and allocated to receive either ginger root powder or a placebo. Ginger root powder was administered orally (0.5 g, 2 capsules per day, 0.25 g per capsule, every 12 hours) for 5 days beginning on the first day of chemotherapy. The incidence and severity of acute and delayed nausea and vomiting were assessed using the MASCC (Multinational Association for Supportive Care in Cancer) Antiemesis Tool (MAT). Adverse effects and patient adherence were also assessed in this study. No significant difference was observed between the ginger and control groups in the reduction of the incidence and severity of nausea and vomiting ( P > .05). No significant difference in adverse events was observed between the 2 groups ( P > .05). No study-treatment-related adverse events were observed in this study. As an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens.

scholarly journals Evaluation of the Effectiveness of Cinnamon Oil Soft Capsule in Patients with Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Mehdi Zobeiri ◽  
Fatemeh Parvizi ◽  
Zahra Shahpiri ◽  
Fatemeh Heydarpour ◽  
Morteza Pourfarzam ◽  
...  
Keyword(s):  
Functional Dyspepsia ◽  
Gastrointestinal Symptom ◽  
Epigastric Pain ◽  
Controlled Trial ◽  
Sesame Oil ◽  
Dyspeptic Symptom ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Cinnamon Oil ◽  
Significant Difference

Background. Different effects of cinnamon and its oil in traditional medicine in the treatment of diseases, including gastrointestinal diseases, were reported. The aim of this study is to evaluate the efficacy and safety of cinnamon oil (Cinnamomum zeylanicum) in patients with functional dyspepsia in a double-blind, randomized placebo-controlled trial. Methods. Soft gelatin capsule was made using the rotary die process, and the final capsule was standardized based on its cinnamaldehyde amount and analyzed by high-performance liquid chromatography (HPLC) method. Sixty-four patients with symptomatic functional dyspepsia were randomized to receive cinnamon oil soft capsule (n = 29) or sesame oil soft capsule as placebo (n = 35) for 6 weeks. The primary efficacy variable was the sum score of the patient’s gastrointestinal symptom (five‐point scale). Secondary variables were the scores of each dyspeptic symptom including severity of vomiting, sickness, nausea, bloating, abdominal cramps, early satiety, acidic eructation/heartburn, loss of appetite, retrosternal discomfort, and epigastric pain/upper abdominal pain, as well as any reported adverse events. Results. The results showed that, after 6 weeks of treatment, the cinnamon oil and placebo groups significantly decreased the total dyspepsia score compared to the baseline at the endpoint ( P < 0.001 ). However, there was no significant difference between the cinnamon oil and placebo groups in terms of the baseline and endpoint values of the outcome variables ( P = 0.317 and P = 0.174 , respectively). Two patients in the cinnamon oil group complained of rashes, and three patients in the placebo group complained of nausea. Conclusion. This study showed significant improvements in gastrointestinal symptom score in both treatment and placebo groups. However, there was no significant difference between the cinnamon oil and sesame oil groups in terms of the baseline and endpoint values of the outcome variables. This study was registered as https://clinicaltrials.gov/ct2/show/IRCT20170802035460N2, 29 December 2017, in the Iranian Registry of Clinical Trials with https://www.IRCT.ir.

scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P &lt; 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

scholarly journals Effect of Different Volumes on Pain Relief in Patient Receiving Fluoroscopic Guided Interlaminar Lumbar Epidural Steroid Injection

2018 ◽  
Vol 1 (21;1) ◽  
pp. 243-249 ◽  
Author(s):  
Jeetinder Kaur Makkar
Keyword(s):  
Pain Relief ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Secondary Outcome ◽  
Double Blind ◽  
Iodinated Contrast ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Epidural Steroid

Background: Epidural steroids injections (ESI) are frequently used to treat lumbar radicular pain. Although different volume have been used for interlaminar ESI in adults, there is no controlled trial comparing the effect of different volumes on pain relief for the same dose of steroid . Objective: To compare the effect of increase in volume of epidural drug on pain relief in lumbar ESI . Study design: Randomized double blind trial Settings: Pain OR of a tertiary care centre Methods: Sixty patients were randomly allocated to 1 of 3 groups: Group A (4 mL), Group B (6 mL), and Group C (8 mL). Pain was evaluated using visual analog scale (VAS) and improvement in disability using modified Oswestry Disability Questionnaire scores (MODQS) at 2, 4, 8, 12, and 24 weeks. Patients having less than 50% pain relief from baseline received an additional epidural injection of the same volume with a maximum of 3 injections at least 15 days apart. The primary objective of the study was incidence of patients attaining more than 50% pain relief at 6 months. Secondary outcome included MODQS and pattern of spread of iodinated contrast on fluoroscopy. Results: At the end of 6 months, there was no significant difference in the effective pain relief between the 3 groups (Group A-16/22 (72.7%), Group B-15/20 (75%), Group C-13/18 (72.2%); P = 0.98, chi- square test). All groups demonstrated a significant reduction in mean VAS scores. There was no significant intergroup difference in VAS sores and MODQS at all the time intervals. The pattern of contrast spread did not differ between the 3 groups. Limitation: Not a placebo controlled trial Conclusions: An increase in volume of the injectate from 4 mL to 8 mL did not increase the efficacy of interlaminar ESI. Key words: Epidural steroid, volume, low back pain, interlaminar:

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