Prospective study on Incidence and Functional Impact of Transient Neurologic Symptoms Associated with 1%Versus  5% Hyperbaric Lidocaine in Short Urologic Procedures

2003 ◽  
Vol 98 (2) ◽  
pp. 485-494 ◽  
Author(s):  
Doris Tong ◽  
Jean Wong ◽  
Frances Chung ◽  
Mark Friedlander ◽  
Joseph Bremang ◽  
...  
Keyword(s):  
Prospective Study ◽  
Controlled Trial ◽  
Double Blind ◽  
Neurologic Symptoms ◽  
Intention To Treat ◽  
Pain Scores ◽  
Significant Difference ◽  
Functional Scores ◽  
Urological Procedures ◽  
To Receive

Background The objectives of this study were to compare the incidence, onset, duration and pain scores of transient neurologic symptoms (TNS) with 1% versus 5% hyperbaric lidocaine in spinal anesthesia for short urological procedures in a large prospective study. This study would also evaluate patient satisfaction, and impact of TNS on functional recovery to assess the clinical significance of TNS. Methods This was a multicenter, double-blind, randomized controlled trial. Four hundred fifty-three patients undergoing short transurethral procedures were randomized to receive 1% or 5% hyperbaric lidocaine. Eighty milligrams of 1% or 5% hyperbaric lidocaine was administered. During the first 3 days after surgery, the presence of TNS, its intensity and duration, and patient functional level were recorded. An intention-to-treat analysis was used. Results There was no difference in the incidence of TNS (21% vs. 18%) between 1% versus 5% lidocaine. Patients with TNS had significantly higher pain scores (5.3 +/- 3 vs. 2.3 +/- 3) than patients without TNS during the first 24 h. This difference in pain scores persisted until 72 h postoperatively. There was a significant difference in the daily activities functional scores (2.2 +/- 1 vs. 1.4 +/- 0.8) of TNS non-TNS patients during the first 24 h postoperatively. Conclusions There was no difference in the incidence of TNS between the 1% versus 5% spinal lidocaine groups. Pain scores were higher in patients with TNS than those who did not have TNS. During the first 48 h postop, a small proportion of patients who had TNS experienced functional impairment of walking, sitting, and sleeping.

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

1988 ◽  
Vol 69 (5) ◽  
pp. 687-691 ◽  
Author(s):  
Ross Bullock ◽  
James R. van Dellen ◽  
William Ketelbey ◽  
S. Gustav Reinach
Keyword(s):  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Risk Of Infection ◽  
Broad Spectrum Antibiotic ◽  
Wound Sepsis ◽  
Double Blind ◽  
Content Type ◽  
Exact Test ◽  
Significant Difference ◽  
To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

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

scholarly journals Effectiveness of a Fortified Drink in Improving B Vitamin Biomarkers in Older Adults: A Controlled Intervention Trial

2021 ◽  
Author(s):  
Maria Heffernan ◽  
Leanne C Doherty ◽  
Roberta Hack Mendes ◽  
Michelle Clarke ◽  
Stephanie Hodge ◽  
...  
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
B Vitamins ◽  
Double Blind ◽  
Intention To Treat ◽  
Vitamin Status ◽  
Randomised Controlled ◽  
B Vitamin ◽  
To Receive

Abstract BackgroundOlder adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in B vitamin biomarker concentrations.MethodsA multicentre double-blind randomised controlled trial was performed in University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming >4 portions of B-vitamin fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease. Recruited participants were randomised with gender and centre as factors in the randomisation to receive either B vitamin-fortified or placebo drinks (developed by Smartfish, Norway) daily for 16 weeks.ResultsA total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed - 37 in the active and 33 in the placebo groups. Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamins biomarkers in the active compared to placebo groups (p<0.01 for Folate, Vitamin B12, Vitamin B6, and Riboflavin). A significant lowering of plasma homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L (functional marker of B vitamin status) was also observed in response to the active treatment (P<0.001). Similar results were seen in a per-protocol analysis.ConclusionsThe results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention strategy to improve B vitamin status in older adults. Trial registration: ISRCTN, ISRCTN61709781. - Retrospectively registered, https://www.isrctn.com/ISRCTN61709781

Randomized double-blind placebo-controlled trial of celecoxib for radiation-induced oral mucositis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9620-9620
Author(s):  
Rajesh V. Lalla ◽  
Linda E. Choquette ◽  
Kathleen F. Curley ◽  
Robert J. Dowsett ◽  
Richard S. Feinn ◽  
...  
Keyword(s):  
Oral Mucositis ◽  
Fixed Effects ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
T Test ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pain Scores ◽  
Significant Difference ◽  
Cox 2

9620 Background: Oral mucositis (OM) is a painful complication of radiation therapy (RT) for head and neck (H&N) cancer. OM can compromise nutrition, require opioid analgesics and hospitalization for pain control, and lead to treatment interruptions. Due to the role of inflammatory pathways in the pathogenesis of OM, this study investigated the effect of inhibition of cyclooxygenase-2 (COX-2) on severity and morbidity of OM. Methods: In this randomized double-blind placebo-controlled trial,40 H&N cancer patients were randomized to daily use of 200 mg celecoxib or matched placebo, for the duration of RT. Eligibility criteria included planned RT dose of ≥ 5000 cGy to 2+ areas of the mouth and no contraindication for celecoxib use. The planned sample size of 20 per arm provided 80% power to detect a 1 point difference in mean Oral Mucositis Assessment Scale (OMAS) score (range 0-5) at 5000 cGy RT (primary endpoint), applying a two-tailed, two-sample t-test at the 5% level of significance. Clinical OM, normalcy of diet, pain scores and analgesic use were assessed 2-3 times a week by blinded investigators during the 6-7 week period of RT, using validated scales. Results: Twenty subjects were randomized to each arm, which were similar with respect to tumor location, radiation dose, and concomitant chemotherapy. In both arms, mucositis and pain scores increased over the course of RT. Intent-to-treat analyses demonstrated no significant difference in mean (SD) OMAS scores at 5000 cGy [celecoxib 1.32 (0.71), placebo 1.27 (0.86), p = 0.83, two sample t-test]. There was also no difference between the celecoxib and placebo arms respectively, in mean OMAS scores over the period of RT (SD) [0.98(0.77) & 0.97 (0.86), p = 0.84], mean worst pain scores [3.38 (3.07) & 3.31 (3.32), p = 0.83], mean normalcy of diet scores [5.43 (3.86) & 5.11(3.94), p = 0.65], or mean daily opioid medication use in IV morphine equivalents [19.08 (16.57) & 20.48 (19.07), p = 0.48], all by linear mixed model fixed effects regression analysis. There were no SAEs attributed to celecoxib use. Conclusions: Daily use of a selective COX-2 inhibitor, during the period of RT for H&N cancer, did not reduce the severity of clinical OM, pain, dietary compromise or use of opioid analgesics. Clinical trial information: NCT00698204.

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic: A Randomized, Double-Blind Controlled Trial

Hand ◽  
2019 ◽  
pp. 155894471988466
Author(s):  
J. Randall Patrinely ◽  
Shepard P. Johnson ◽  
Brian C. Drolet
Keyword(s):  
Local Anesthetic ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Treatment Method ◽  
Trigger Finger ◽  
Injection Pain ◽  
Double Blind ◽  
Pain Scores ◽  
Injection Methods ◽  
To Receive

Background: The first-line treatment for trigger finger is a corticosteroid injection. Although the injectable solution is often prepared with a local anesthetic, we hypothesize that patients receiving an injection with anesthetic will experience more pain at the time of injection. Methods: C Patients with trigger finger were prospectively randomized into 2 cohorts to receive triamcinolone (1 mL, 40 mg) plus 1% lidocaine with epinephrine (1 mL) or triamcinolone (1 mL, 40 mg) plus normal saline (1 mL, placebo). Both patient and surgeon were blinded to the treatment arm. The primary outcome was pain measured using a (VAS) immediately following the injection. Results: Seventy-three patients with a total of 110 trigger fingers were enrolled (57 lidocaine with epinephrine and 53 placebo). Immediate postinjection pain scores were significantly higher for injections containing lidocaine with epinephrine compared with placebo (VAS 3.5 vs 2.0). Conclusions: In the treatment of trigger finger, corticosteroid injections are effective and have relatively little associated pain. This study shows there is more injection-associated pain when lidocaine with epinephrine is included with the corticosteroid. Therefore, surgeons looking to decrease injection pain should exclude the anesthetic, but they should discuss the trade-off of foregoing short-term anesthesia with patients. Using only a single drug (ie, corticosteroid alone) is not only less painful but is also more simple, efficient, and safe; this has therefore become our preferred treatment method.

scholarly journals Comparison of azithromycin vs doxycycline prophylaxis in leptospirosis, A randomized double blind placebo-controlled trial

2018 ◽  
Vol 12 (11) ◽  
pp. 991-995
Author(s):  
Ahmad Alikhani ◽  
Ebrahim Salehifar ◽  
Fatemeh Zameni ◽  
Alireza Rafiei ◽  
Jamshid Yazdani-charati ◽  
...  
Keyword(s):  
Paddy Field ◽  
Controlled Trial ◽  
Fisher Exact Test ◽  
Mazandaran Province ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Informed Consent Form ◽  
Significant Difference ◽  
Field Workers ◽  
To Receive

Introduction: Leptospirosis is an important zoonotic disease in paddy field with 29.5% prevalence rate in Mazandaran province and 4% to 52% mortality rate among hospitalized patients. Prevention is an important strategy for the control of this disease. This study aimed to compare the prophylactic effect of azithromycin versus doxycycline against leptospirosis in an endemic area in north of Iran. Methodology: In this randomized double-blind placebo-controlled trial, paddy field workers (n = 187) were randomized to receive azithromycin (500mg weekly), doxycycline (200 mg weekly) or placebo starting one week before exposure to paddy field, during and to four weeks after. Paddy field workers aged 18- 65 years who signed the informed consent form were assessed for signs and symptoms of leptospirosis in addition to serologic evidence of the disease 6th and 12th week. Data were analyzed with SPSS version 13 using Chi-square and Fisher exact test and ANOVA. Results: From June to September 2016, 187 participants were entered the study to receive azithromycin (n = 66), doxycycline (n = 71) or placebo (n = 50). In terms of preventing against clinical leptospirosis, there was not any significant difference between three arms, though there was statistically significant difference of seropositivity after 6 and 12 weeks in comparison to baseline among all three groups (P = 0.029) and between active treatment (eg. azithromycin and doxycycline) groups and placebo group (P = 0.01). Conclusion: Azithromycin like doxycycline decreased seropositivity without significant effect on clinical leptospirosis.

scholarly journals Intrauterine levobupivacaine for pain control during intrauterine device insertion

2017 ◽  
Vol 6 (3) ◽  
pp. 1117
Author(s):  
Nilufer Akgun ◽  
Esra Keskin ◽  
Muberra Namlı Kalem ◽  
Batuhan Bakirarar
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Saline Control ◽  
Control Group ◽  
Double Blind ◽  
Pain Scores ◽  
Significant Difference ◽  
Vas Scores

Background: Safe, effective, long term and a reversible contraception method is offered by intrauterine devices (IUDs).  The objective was to determine the potency of intrauterine administration of 5 cc levobupivacain for pain relief with IUD insertion, when compared with saline placebo.Methods: This was a prospective randomized, double blind placebo-controlled trial undergoing İUD insertion. The trial medication was intrauterine anesthesia, either 5 mL 0.9% saline (control group), or 5 mL 0.5% levobupivacaine. Our primary outcome was self-reported pain scores on a 10 cm visual analogue scale (VAS) immediately following IUD insertion.Results: 95 women were enrolled, and data for 88 women were analyzed. In IUD insertion procedure, no difference was observed between groups during teneculum placement and solution administration, in the course of VAS scores (p=0.349, p=0.396). There was a significant difference in the VAS scores measuring pain suffering during and after IUD procedure (p=0.001).Conclusions: Intrauterine instillation of 5 cc of levobupivacaine along with saline solution reduces pain with IUD insertion when compared to intrauterine saline placebo. Broad deviation in pain scores and persistent pain after IUD insertion recommends that patient would benefit from more functioning method of pain control than before at IUD insertion and during the post interval.

scholarly journals The Effects of Quetiapine on Craving and Withdrawal Symptoms in Methamphetamine Abuse: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 10 (4) ◽  
pp. 29374.1-29374.7
Author(s):  
Najme Sadat Javdan ◽  
◽  
Amir Ghaderi ◽  
Hamid Reza Banafshe ◽  
◽  
...  
Keyword(s):  
Controlled Trial ◽  
Withdrawal Symptoms ◽  
Chi Square ◽  
Double Blind ◽  
Methamphetamine Abuse ◽  
Beneficial Effects ◽  
Amphetamine Withdrawal ◽  
Significant Difference ◽  
Chi Square Test ◽  
To Receive

Background: Patients with Methamphetamine Abuse (MA) are susceptible to many complications like craving, and withdrawal symptoms. These trials were designed to evaluate the effect of quetiapine administration on craving and withdrawal symptoms in MA abuse. Methods: This trial was conducted on 60 people with MA abuse to receive either 100 mg quetiapine (n=30), or placebo (n=30) every day for 2 months. The Desire for Drug Questionnaire (DDQ) and Amphetamine Withdrawal Questionnaire (AWQ) scores were evaluated at baseline and after 2 months’ intervention. For data analysis, t test, and the Chi-square test were applied in SPSS v. 18. Results: Quetiapine significantly decreased DDQ (P=0.002) and AWQ symptoms (P=0.001) compared to the placebo. Furthermore, there was a significant difference among groups in terms of the frequency of negative urine tests (P<0.001). Conclusion: This trial showed that administration of quetiapine supplements for 2 months in individuals with MA abuse had beneficial effects on craving and withdrawal syndrome.

scholarly journals Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries

2011 ◽  
Vol 91 (2) ◽  
pp. 150-155 ◽  
Author(s):  
A.S. Papas ◽  
W.M. Vollmer ◽  
C.M. Gullion ◽  
J. Bader ◽  
R. Laws ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Tooth Surface ◽  
Placebo Control ◽  
Double Blind ◽  
Intention To Treat ◽  
Significant Difference ◽  
Registration Number ◽  
Secondary Outcomes ◽  
Study Participants ◽  
To Receive

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries ( Clinicaltrials.gov registration number NCT00357877).

scholarly journals Intramuscular Ketorolac for Postoperative Analgesia following Laparoscopic Sterilisation

1994 ◽  
Vol 22 (1) ◽  
pp. 22-24 ◽  
Author(s):  
M. H. Shapiro ◽  
B. L. Duffy
Keyword(s):  
Side Effects ◽  
Intramuscular Injection ◽  
Double Blind Study ◽  
Day Case ◽  
Double Blind ◽  
Apparent Lack ◽  
Pain Scores ◽  
Significant Difference ◽  
To Receive ◽  
Intramuscular Ketorolac

The analgesic effect of intramuscular ketorolac was assessed by double blind study in forty women presenting for day-case laparoscopic sterilisation. The patients were randomly allocated to receive either ketorolac 30 mg or saline by intramuscular injection immediately following induction of general anaesthesia. There was no statistically significant difference between the groups in pain scores, opioid requirements or incidence of nausea and vomiting in the postoperative period. In view of the potential side-effects of ketorolac, and the apparent lack of efficacy when used prophylactically, the routine use of the drug in this group of patients cannot be recommended.

Sign in / Sign up

Export Citation Format

Share Document