Can post-tonsillectomy pain be reduced by topical bupivacaine? Double blind controlled trial

1989 ◽  
Vol 103 (6) ◽  
pp. 592-593 ◽  
Author(s):  
N.S. Violaris ◽  
J.R. Tuffin
Keyword(s):  
Normal Saline ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Prospective Trial ◽  
The Other ◽  
Cent Solution ◽  
Double Blind ◽  
Tonsillar Fossa ◽  
Significant Difference ◽  
Adult Tonsillectomy

AbstractA double blind controlled prospective trial investigated the analgesic effect of topical Bupivacaine in 15 adult patients undergoing bilateral tonsillectomy. Each patient had one tonsillar fossa exposed to Bupivacaine 0.5 per cent solution and the other to normal saline. When visited four to six hours post-operatively, 12 out of 15 patients (80 per cent) stated that the Bupivacaine exposed side to be more uncomfortable than the saline exposed side. On the first post-operative mornning 9 out of 15 patients (60 per cent) confirmed the same. The remaining patients were unable to detect a significant difference and no patient found the Bupivacaine side to be more comfortable.These results suggest that topical Bupivacaine 0.5 per cent solution has no place in providing post-operative analgesia in adult tonsillectomy.

A Double-Blind Comparative Clinical Trial of Floctafenine and Four Other Analgesics Conducted in General Practice

1976 ◽  
Vol 4 (3) ◽  
pp. 179-182 ◽  
Author(s):  
D M Lomas ◽  
J Gay ◽  
R N Midha ◽  
D L Postlethwaite
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Analgesic Effect ◽  
Rank Order ◽  
Controlled Trial ◽  
The Other ◽  
Double Blind ◽  
Comparative Clinical Trial

Three hundred and twelve patients suffering from painful conditions were admitted to a multicentre, double-blind controlled trial, conducted in general practice in which five analgesics—floctafenine (Idarac), paracetamol, aspirin, dihydrocodeine and pentazocine—were compared. Overall ratings of analgesic effect placed floctafenine first in rank order. Floctafenine was statistically significantly superior in effect to pentazocine but not to the other three agents as far as doctor ratings were concerned; and superior to both pentazocine and dihydrocodeine in the opinion of patients. Fewer patients experienced side-effects on floctafenine than on the other four analgesics and this difference between floctafenine and pentazocine, and floctafenine and dihydrocodeine was statistically significant.

The Value of Iron Therapy in Pica

PEDIATRICS ◽  
1964 ◽  
Vol 34 (4) ◽  
pp. 558-562
Author(s):  
ROBERT MCDONALD ◽  
SHEILA R. MARSHALL
Keyword(s):  
Normal Saline ◽  
Controlled Trial ◽  
Hemoglobin Level ◽  
Iron Therapy ◽  
Control Group ◽  
Double Blind ◽  
Intramuscular Injections ◽  
Significant Difference ◽  
Permanent Cure

As doubt had been cast upon the reputed efficacy of iron in the treatment of pica, a double blind controlled trial was carried out in an endeavor to establish a firmer conclusion in the matter. One group of children received intramuscular iron and a control group of equal mean age were given intramuscular injections of normal saline. Three to 4 months later nearly all of those given iron had lost their pica, but it was still present in three-quarters of the controls. After 5 to 6 months there was no significant difference between the two groups and this failure of maintenance of cure may have been related to a fall in mean hemoglobin level which occurred. Five children who initially received saline and in whom pica was still present were given iron at 6 months and all lost their pica. Our experience is that pica can be cured by iron in nearly all cases, but that permanent cure may be dependent upon the maintenance of adequate hemoglobin levels.

scholarly journals The Effect of Methylphenidate on Reed Scaling in Benzodiazepine Poisoning: A Prospective Trial

2020 ◽  
Vol 15 (1) ◽  
pp. 81-88
Author(s):  
Masoud Latifi-Pour ◽  
Hossein Hassanian-Moghaddam ◽  
Helya-Sadat Mortazavi ◽  
Shahin Shadnia ◽  
Nasim Zamani ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Prospective Trial ◽  
Laboratory Data ◽  
Age Groups ◽  
Acute Poisoning ◽  
P Value ◽  
Poison Center ◽  
Double Blind ◽  
Laboratory Confirmation ◽  
Significant Difference

Background: Benzodiazepine is one of the most important causes of substance abuse and intoxication throughout the world and Iran. Objective: The aim of our study is to determine the role of stimulants in reversing CNS level in acute Benzodiazepine poisoning patients who were hospitalized at referral poison center. Methods: This was a randomized double-blind placebo-controlled trial study on 32 cases with pure acute Benzodiazepine poisoning from March 2016 to February 2017. Diagnosis of pure acute poisoning was based on history, and laboratory confirmation. We gathered the demographics, clinical data, laboratory data, hospitalization and outcome. Participants were randomized into two groups: Methylphenidate Group (MPH) and Placebo Group (PBO). Results: The randomized sample consisted of 32 participants who were predominately female (83%). The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005). Paired sample t-test analyses on Reed Scale data revealed an increase in the probability of improvement during the trial for the MPH group compared to the PBO group. Furthermore, the HCo3 (bicarbonate) level has a significant p-value with respect to age groups (p = .02). None of our cases required either the ICU facility or intubation. Conclusion: Our study provided the MPH superiority over PBO in reversing CNS symptoms in loss of consciousness in acute BZD poisoned patients. Thus, this trial provides concrete evidence that improvement in consciousness levels (Reed Scale rated) among those patients receiving MPH was associated with a methylphenidate use.

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 Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

scholarly journals 1241. PfSPZ Vaccine Administered by Direct Venous Inoculation to Prevent Plasmodium falciparum Malaria is as Safe as Normal Saline – a Meta-analysis of 12 Randomized Controlled Clinical Trials

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S639-S640
Author(s):  
L W Preston Church
Keyword(s):  
Plasmodium Falciparum ◽  
Random Effects ◽  
Normal Saline ◽  
Meta Analysis ◽  
Laboratory Data ◽  
Plasmodium Falciparum Malaria ◽  
Sub Saharan Africa ◽  
Sensitivity Analyses ◽  
Double Blind ◽  
Significant Difference

Abstract Background Sanaria’s PfSPZ Vaccine prevents Plasmodium falciparum (Pf) infection transmitted in the field and by controlled human malaria infection. Safety of PfSPZ Vaccine has been demonstrated in 12 randomized, double-blind, placebo-controlled trials (RCT) varying in regimen from 3 to 5 doses over 4 to 20 weeks and in size from 18 to 332 subjects in adults in the US and EU and 5-month to 65-year-olds in 5 countries in sub-Saharan Africa. This study was conducted to analyze solicited adverse event (AE) and laboratory data by random effects meta-analysis. Methods PfSPZ Vaccine is composed of radiation-attenuated, aseptic, purified, cryopreserved Pf sporozoites (SPZ) administered by direct venous inoculation (DVI). Normal saline (NS) is always the placebo. Data from all completed RCTs were included as either age &gt; 18 years (n=598) or age 5 months to 17 years (n=641). Any subject receiving at least one dose was included. A random-effects model was used to study vaccine safety and I2 to evaluate heterogeneity. Analysis was performed for any systemic solicited AE and for the most frequently observed AEs and laboratory abnormalities. Sensitivity analyses were performed by removal of trials with zero events to evaluate potential bias. Results When examined individually, only 1 trial had a significant difference between PfSPZ Vaccine and NS for any AE (myalgias in adults). In the adult meta-analysis, there was no difference in the random effects risk ratios (RR) for having any vaccine-related AEs (1.40, 95% confidence interval (CI) 0.88-2.28), or for fever (0.75, 0.24-2.35), headache (1.23, 0.74-2.02), fatigue (0.72, 0.19-2.54), or myalgia (1.09, 0.26-4.68). In the pediatric meta-analysis there was no difference between the RR for PfSPZ Vaccine and NS for any AE (0.84, 0.59-1.18) or for fever (1.09, 0.44-2.69). No significant differences in the most common grade 2 or higher laboratory abnormalities – declines in hemoglobin, neutrophil or platelet count – were detected. Sensitivity analysis did not change the results. Conclusion There was no difference in risk for AEs or lab abnormalities between PfSPZ Vaccine and NS, indicating that PfSPZ Vaccine administered by DVI was extremely safe and well tolerated in 5-month- to 65-year-olds. Disclosures LW Preston Church, MD, FIDSA, Sanaria Inc. (Employee)

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

scholarly journals A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

2018 ◽  
Vol 27 (3) ◽  
pp. 178-84 ◽  
Author(s):  
Githa Rahmayunita ◽  
Tjut N.A. Jacoeb ◽  
Endi Novianto ◽  
Wresti Indriatmi ◽  
Rahadi Rihatmadja ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Manifestations ◽  
Effective Treatment Option ◽  
Psoriasis Area Severity Index ◽  
Double Blind ◽  
Old Patients ◽  
Mean Values ◽  
Significant Difference ◽  
Curcuma Xanthorrhiza ◽  
The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

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