scholarly journals Hystroscopic cornual nerve block in operative hysteroscopy: a Randomized controlled trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
M I Amer ◽  
M M Abdelaleem ◽  
Y M Elrefaey
Keyword(s):  
Nerve Block ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
Visual Analogue Score ◽  
University Hospital ◽  
Controlled Study ◽  
Double Blind ◽  
Operative Hysteroscopy ◽  
Number Of Patients ◽  
Ethical Approval

Abstract Background Hysteroscopy has become a standard investigation for a lot of gynecological cases and found to be effective in detecting intrauterine pathology and treating it. It is usually performed as an outpatient procedure under either local or no anesthesia. Aim of the Work to assess the anesthetic efficacy of intracornual nerve block versus placebo in reducing pain & discomfort during operative hysteroscopy. Patients and Methods This randomized, double-blind, placebo-controlled study was conducted on 58 patients at the Early Cancer Detection and Endoscopy Unit (Ain Shams university Hospital) after taking Full ethical approval for the study. Patients referred for outpatient hysteroscopy (between march 2018 and December 2018) were informed about the possible role of intracornual nerve block in reducing pain that could be experienced during the procedure, and were asked to participate. Signed informed consent was obtained from all patients who agreed to participate in the study. Results Among the 42 women who underwent successful operative intervention, the visual analogue score for assessment of intra-operative pain was statistically significantly lower in the LA-ICOB group compared to the placebo-ICOB group. In the same context, the number of patients requiring extra analgesia (either as NSAIDs or opioid analgesics) was statistically significantly larger in the placebo-ICOB group compared to the LA-ICOB group. Conclusion This study proved that the use of intracornual nerve block in operative hysteroscopy is both beneficial and effective in reducing pain and discomfort that could associate operative hysteroscopy procedure.

Asymptotic and exact interval estimators of the common odds ratio under the sequential parallel comparison design

2018 ◽  
Vol 28 (10-11) ◽  
pp. 3074-3085 ◽  
Author(s):  
Kung-Jong Lui
Keyword(s):  
Odds Ratio ◽  
Controlled Trial ◽  
Placebo Response ◽  
Controlled Study ◽  
Double Blind ◽  
Number Of Patients ◽  
Mental Diseases ◽  
The Common ◽  
Interval Estimators ◽  
Conditional Maximum

When studying treatments for psychiatric or mental diseases in a placebo-controlled trial, we may consider use of the sequential parallel comparison design to reduce the number of patients needed through the reduction of the high placebo response rate. Under the assumption that the odds ratio of responses is constant between phases in the sequential parallel comparison design, we derive the conditional maximum likelihood estimator for the odds ratio. On the basis of the conditional likelihood, we further derive three asymptotic interval and an exact interval estimators for the odds ratio of responses. We employ Monte Carlo simulation to evaluate the performance of these interval estimators in a variety of situations. We find that the asymptotic interval and exact interval estimators developed here can all perform well. We use the double-blind, placebo-controlled study assessing the efficacy of a low dose of aripiprazole adjunctive to antidepressant therapy for treating patients with major depressive disorder to illustrate the use of these estimators.

scholarly journals Premedication with Oral Alprazolam and Melatonin Combination: A Comparison with Either Alone—A Randomized Controlled Factorial Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Krishna Pokharel ◽  
Mukesh Tripathi ◽  
Pramod Kumar Gupta ◽  
Balkrishna Bhattarai ◽  
Sindhu Khatiwada ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Controlled Trial ◽  
Visual Analogue Score ◽  
Sedation Score ◽  
Combination Drug ◽  
Chi Square ◽  
Double Blind ◽  
Amnesic Effect ◽  
Time Points ◽  
Number Of Patients

We assessed if the addition of melatonin to alprazolam has superior premedication effects compared to either drug alone. A prospective, double blind placebo controlled trial randomly assigned 80 adult patients (ASA 1&2) with a Visual Analogue Score (VAS) for anxiety ≥3 to receive a tablet containing a combination of alprazolam 0.5 mg and melatonin 3 mg, alprazolam 0.5 mg, melatonin 3 mg, or placebo orally 90 min before a standard anesthetic. Primary end points were change in anxiety and sedation score at 15, 30, and 60 min after premedication, and number of patients with loss of memory for the five pictures shown at various time points when assessed after 24 h. One-way ANOVA, Friedman repeated measures analysis of variance, Kruskal Wallis and chi square tests were used as relevant. Combination drug produced the maximum reduction in anxiety VAS (3 (1.0–4.3)) from baseline at 60 min (P<0.05). Sedation scores at various time points and number of patients not recognizing the picture shown at 60 min after premedication were comparable between combination drug and alprazolam alone. Addition of melatonin to alprazolam had superior anxiolysis compared with either drugs alone or placebo. Adding melatonin neither worsened sedation score nor the amnesic effect of alprazolam alone. This study was registered, approved, and released from ClinicalTrials.gov. Identifier number:NCT01486615.

scholarly journals Diphenhydramine Definitely Suppresses Fentanyl-Induced Cough During General Anesthesia Induction: A Double-Blind, Randomized, and Placebo-Controlled Study

2019 ◽  
Author(s):  
Pejman Pourfakhr ◽  
Seyed Hashem Ziaei ◽  
Farhad Etezadi ◽  
Mohamadreza Sharifinia ◽  
Mohammad Reza Khajavi
Keyword(s):  
Recovery Room ◽  
Controlled Trial ◽  
Study Groups ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Control Group ◽  
Anesthesia Induction ◽  
Analgesic Requirement ◽  
Double Blind ◽  
Number Of Patients

Fentanyl-induced cough (FIC) is a known complication, and many studies have been conducted to prevent it. The aim of this study was to evaluate the effectiveness of Diphenhydramine as an antihistamine in suppressing of FIC during induction of anesthesia. In a prospective, double-blind, randomized controlled trial, a total of 100 patients, ASA Class I and II, scheduled for elective laparoscopy surgery were randomly assigned into two equally sized groups (n=50). Diphenhydramine diluted with distilled water as 10 mg/ml. Then, patients in Group D, received diphenhydramine 30 mg (3 ml) through peripheral IV line within 1 min and Group C received the same volume normal saline 0.9% as placebo. Two min later, fentanyl 2 µg/kg was administered through the peripheral IV line within 5 sec in all patients. The occurrence and intensity of cough within 2 min after the fentanyl injection were observed and recorded by a resident who was blinded to the study groups. The frequency of PONV, analgesic requirement in the recovery room and as a secondary outcome were recorded. The incidences of FIC were 47% in the control group, and there is no cough in the diphenhydramine group (P=0.02). The frequency of PONV was also reduced in diphenhydramine group (16% vs. 40%) and less number of patients in diphenhydramine group was needed to analgesia in the recovery room (60% vs. 82%). Our study determines that diphenhydramine (30 mg, IV) bolus injection 2 min before fentanyl injection can prevent FIC and PONV and also reduce analgesic requirement inthe recovery room. © 2019 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2019;57(5):316-319.

Placebo-Controlled Trial of Naftazone in Women with Primary Uncomplicated Symptomatic Varicose Veins

1997 ◽  
Vol 12 (1) ◽  
pp. 17-20 ◽  
Author(s):  
M. Vayssairat ◽  
Keyword(s):  
Analogue Scale ◽  
Time Course ◽  
Varicose Veins ◽  
Controlled Trial ◽  
Group Versus ◽  
University Hospital ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Dosage Regimens

Objective: To evaluate the effectiveness and best time course of prescription of 30 mg/day oral naftazone (N) in women with primary uncomplicated symptomatic varicose veins (PUSVV). Design: Double-blind, placebo (P)-controlled study. Setting: Multicentre study, coordinated by a University hospital in Paris, France. Patients: 270 women with PUSVV. Interventions: Treatment with naftazone (three dosage regimens) or placebo for 14 days. Main outcome measures: Comparison by ANOVA, at day 0 and after 14 days of treatment, of (1) clinical disability, using an analogue scale 100 mm long and (2) morning and evening leg volumes. Results: The reduction in disability at day 14 was 32 ± 23 mm in the N group versus 24 ± 20 in the P group, F = 6.35, p = 0.01. Best clinical efficacy was obtained in the subgroup given 30 mg N once a day at midday (35 ± 22 mm). Differences between morning leg volumes on days 0 and 14 were 19.3 ± 74 ml in the N group versus 5.5 ± 50 in the P group, p = 0.059. Conclusion: Naftazone was more effective than placebo for the clinical improvement of women with PUSVV.

Safety and Efficacy of Injectable Pentigetide: Double-Blind, Placebo-Controlled Study in Patients with Allergic Rhinitis

1989 ◽  
Vol 3 (3) ◽  
pp. 155-161
Author(s):  
Bruce M. Prenner ◽  
Kathryn F. Rangus ◽  
Michael A. Eldon
Keyword(s):  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Study Completion

Pentigetide is a synthetic pentapeptide derived from the Fc region of human IgE reported to inhibit IgE-mediated allergic responses. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of subcutaneously administered pentigetide in the treatment of allergic rhinitis. After a 3-day baseline period, 55 patients received 5 injections of either 20 mg of pentigetide for injection (n = 31) or placebo solution (n = 24), one injection every 3 to 4 days for 14 days. Physician assessment of frequency and severity of sneezing, rhinorrhea, congestion, nasal itching, and 3 non-nasal symptoms obtained at baseline, after 1 week, and study completion were compared between pentigetide and placebo treatment groups. The physician's assessment of therapeutic response made at study completion showed that 71% of patients receiving pentigetide were improved, whereas 37% of patients receiving placebo had improved, a difference which was statistically (chi square, p = 0.013) as well as clinically significant. Mean symptom scores indicated that the frequency and severity of sneezing, rhinorrhea, and nasal itching decreased after 1 week of pentigetide treatment and remained decreased until study completion, whereas congestion was unchanged or slightly increased. In contrast, the frequency and severity of sneezing, rhinorrhea, and nasal itching increased after placebo treatment, with congestion essentially unchanged. No clinical or statistical differences in safety parameters between pentigetide and placebo treatments were observed. The results of this pilot trial suggested that subcutaneous pentigetide is safe and effective in the treatment of allergic rhinitis and justified expanded safety and efficacy studies in a greater number of patients treated for a longer period of time.

scholarly journals Acute Effects of Triiodothyronine on Endothelial Function in Human Subjects

2007 ◽  
Vol 92 (1) ◽  
pp. 250-254 ◽  
Author(s):  
Raffaele Napoli ◽  
Vincenzo Guardasole ◽  
Valentina Angelini ◽  
Emanuela Zarra ◽  
Daniela Terracciano ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Dose Response ◽  
Vascular Reactivity ◽  
Controlled Trial ◽  
University Hospital ◽  
Acute Effects ◽  
Response Curves ◽  
Double Blind ◽  
Low T3 ◽  
Dose Response Curves

Abstract Context: Thyroid hormone regulates several cardiovascular functions, and low T3 levels are frequently associated with cardiovascular diseases. Whether T3 exerts any acute and direct effect on endothelial function in humans is unknown. Objective: Our objective was to clarify whether acute changes in serum T3 concentration affect endothelial function. Design, Setting, and Subjects: Ten healthy subjects (age, 24 ± 1 yr) participated in a double-blind, placebo-controlled trial at a university hospital. Interventions: T3 (or placebo) was infused for 7 h into the brachial artery to raise local T3 to levels observed in moderate hyperthyroidism. Vascular reactivity was tested by intraarterial infusion of vasoactive agents. Main Outcome Measures: We assessed changes in forearm blood flow (FBF) measured by plethysmography. Results: FBF response to the endothelium-dependent vasodilator acetylcholine was enhanced by T3 (P = 0.002 for the interaction between T3 and acetylcholine). The slopes of the dose-response curves were 0.41 ± 0.06 and 0.23 ± 0.04 ml/dl·min/μg in the T3 and placebo study, respectively (P = 0.03). T3 infusion had no effect on the FBF response to sodium nitroprusside. T3 potentiated the vasoconstrictor response to norepinephrine (P = 0.006 for the interaction). Also, the slopes of the dose-response curves were affected by T3 (1.95 ± 0.77 and 3.83 ± 0.35 ml/dl·min/mg in the placebo and T3 study, respectively; P &lt; 0.05). The increase in basal FBF induced by T3 was inhibited by NG-monomethyl-l-arginine. Conclusions: T3 exerts direct and acute effects on the resistance vessels by enhancing endothelial function and norepinephrine-induced vasoconstriction. The data may help clarify the vascular impact of the low T3 syndrome and point to potential therapeutic strategies.

Optimizing chair time in infusion centers using intravenous cetirizine premedication for the prevention of hypersensitivity infusion reactions.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13508-e13508
Author(s):  
Julio Antonio Peguero ◽  
Ahmed Ayad ◽  
Stacia Young-Wesenberg ◽  
Teresa Yang ◽  
Janine North ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Quality Care ◽  
Primary Objective ◽  
Double Blind ◽  
Acute Urticaria ◽  
Number Of Patients ◽  
Study Results ◽  
Secondary Endpoints ◽  
Infusion Reactions ◽  
Anti Cd20

e13508 Background: Oncology infusion centers are increasingly focused on improving operational efficiencies and patient satisfaction, while maintaining quality care. One key component is optimizing chair time, which has been especially important for patient safety during the COVID-19 pandemic to reduce risk of transmission. Many infusions require antihistamine premedication to reduce the risk of hypersensitivity infusion reactions (IRs). The two IV options are IV diphenhydramine and IV cetirizine, which have a quicker onset than oral options and can be administered IV push. In treating acute urticaria, IV cetirizine was shown to be comparable to IV diphenhydramine, with fewer side effects, and it may be effective for preventing IRs with improved chair time. Methods: A randomized, double-blind phase 2 study evaluating premedication with single dose IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 34 patients receiving paclitaxel, rituximab, its biosimilar or obinutuzumab (first cycle, retreatment after 6 months or with persistent IRs). The primary objective was the incidence of IRs after premedication. Secondary endpoints included sedation due to antihistamines and time to readiness for discharge. Sedation was reported by patients on a scale of 0-4 (0 = none to 4 = extremely severe). No formal statistical analyses were planned given the exploratory nature of the study. Results: Adults primarily with cancer (n = 31 [91%]) were enrolled during the COVID-19 pandemic, from March 25 to November 23, 2020. The median age was 65 and 67 years in the IV cetirizine and diphenhydramine groups, respectively. The number of patients with IRs was 2/17 (11.8%) with IV cetirizine versus 3/17 (17.6%) with IV diphenhydramine. The mean sedation score in the IV cetirizine group compared to the IV diphenhydramine group was lower at all time points, including at discharge (0.1 vs 0.4, respectively). Mean time to discharge was 24 minutes less with IV cetirizine (4.3 hours [1.5]) versus IV diphenhydramine (4.7 hours [1.2]). This difference was greater (30 minutes less) in those ≥65 years of age (4.4 [1.3] vs 4.9 [1.0] hours). Regardless of whether patients received paclitaxel (n = 9) or an anti-CD20 (n = 25), patients had less chair time when premedicated with IV cetirizine. There were fewer treatment-related adverse events (AEs) with IV cetirizine (2 events) than with IV diphenhydramine (4 events). Conclusions: This was the first randomized, controlled trial evaluating IV antihistamine premedication for IRs and chair time. It was shown that IV cetirizine can prevent IRs, with less sedation, fewer related AEs and reduced chair time compared to IV diphenhydramine. This improves infusion center operations and patient experience. Clinical trial information: NCT04189588.

Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽  
2017 ◽  
Vol 32 (7) ◽  
pp. 591-597 ◽  
Author(s):  
Geoff G. Lockwood ◽  
Leilani Cabreros ◽  
Dorota Banach ◽  
Prakash P. Punjabi
Keyword(s):  
Cardiac Surgery ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Subcutaneous Infusion ◽  
Randomised Controlled Study ◽  
Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study

Cephalalgia ◽  
2014 ◽  
Vol 35 (11) ◽  
pp. 959-968 ◽  
Author(s):  
Esma Dilli ◽  
Rashmi Halker ◽  
Bert Vargas ◽  
Joseph Hentz ◽  
Teresa Radam ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Nerve Block ◽  
Preventive Treatment ◽  
Placebo Treatment ◽  
Baseline Period ◽  
Controlled Study ◽  
Double Blind ◽  
Occipital Nerve ◽  
Occipital Nerve Block ◽  
Severe Migraine

Background Occipital nerve (ON) injections with corticosteroids and/or local anesthetics have been employed for the acute and preventive treatment of migraine for decades. However, to date there is no randomized, placebo-controlled evidence to support the use of occipital nerve block (ONB) for the prevention of migraine. Objective The objective of this article is to determine the efficacy of ONB with local anesthetic and corticosteroid for the preventive treatment of migraine. Participants and methods Patients between 18 and 75 years old with ICHD-II-defined episodic (> 1 attack per week) or chronic migraine (modified ICHD-II as patients with > 10 days with consumption of acute medications were permitted into the study) were randomized to receive either 2.5 ml 0.5% bupivacaine plus 0.5 ml (20 mg) methylprednisolone over the ipsilateral (unilateral headache) or bilateral (bilateral headache) ON or 2.75 ml normal saline plus 0.25 ml 1% lidocaine without epinephrine (placebo). Patients completed a one-month headache diary prior to and after the double-blind injection. The primary outcome measure was defined as a 50% or greater reduction in the frequency of days with moderate or severe migraine headache in the four-week post-injection compared to the four-week pre-injection baseline period. Results Thirty-four patients received active and 35 patients received placebo treatment. Because of missing data, the full analysis of 33 patients in the active and 30 patients in the placebo group was analyzed for efficacy. In the active and placebo groups respectively, the mean frequency of at least moderate (mean 9.8 versus 9.5) and severe (3.6 versus 4.3) migraine days and acute medication days (7.9 versus 10.0) were not substantially different at baseline. The percentage of patients with at least a 50% reduction in the frequency of moderate or severe headache days was 30% for both groups (10/30 vs nine of 30, Δ 0.00, 95% CI –0.22 to 0.23). Conclusions Greater ONB does not reduce the frequency of moderate to severe migraine days in patients with episodic or chronic migraine compared to placebo. The study was registered with ClinicalTrial.gov (NCT00915473).

scholarly journals Comparison of the Effect of Lidocaine versus a Lidocaine-Bupivacaine Combination in a Periprostatic Nerve Block Undergoing Transrectal Ultrasound-Guided Prostate Biopsy: A Double-Blind Randomized Controlled Trial

2015 ◽  
Vol 9 (3) ◽  
pp. 153-158 ◽  
Author(s):  
Ali H. Yilmaz ◽  
Elif Ziypak ◽  
Tevfik Ziypak ◽  
Mehmet Aksoy ◽  
Senol Adanur ◽  
...  
Keyword(s):  
Nerve Block ◽  
Local Anesthetic ◽  
Pain Control ◽  
Controlled Trial ◽  
Late Phase ◽  
Patient Comfort ◽  
Double Blind ◽  
Vas Scores ◽  
Long Acting ◽  
Periprostatic Nerve Block

Introduction: To determine whether a combination of the long acting local anesthetic, bupivacaine, and lidocaine is better than lidocaine alone in the long-term pain control, which is a short-acting anesthetic. Materials and Methods: In group 1, periprostatic nerve block was applied to both neurovascular areas with 2% lidocaine (5 ml) in an isotonic solution (5 ml). In group 2, the combination of 2% lidocaine (5 ml) and 5mg/ml bupivacaine (5 ml) was used for the PPNB. Results: In the first 30 minutes the mean VAS scores of groups 1 and 2 were 2.1 ± 0.2 and 1.2 ± 0.1, respectively (p = 0.002). VAS scores of group II determined at 1, 2, 4, 6, and 8 hours after the biopsy were significantly lower since it was (p < 0.05). Conclusion: While periprostatic nerve block for late phase pain control, applying a combination of a long-acting local anesthetic, such as bupivacaine, is effective in terms of pain control and patient comfort.

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