scholarly journals Intracavitary anaesthesia for medical thoracoscopy procedural pain: the CAMP randomised trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Ahmed Mohamed Abdelhady ◽  
Mohamed Gadallah ◽  
Moustafa Shaheen ◽  
Sahar Mourad ◽  
Maged Hassan
Keyword(s):  
Pain Score ◽  
Chest Tube ◽  
Randomised Trial ◽  
Study Groups ◽  
Procedural Pain ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Lidocaine Group ◽  
Medical Thoracoscopy

Abstract Background Medical thoracoscopy (MT) under conscious sedation can be a painful procedure. A pilot study reported reduction in procedural pain with lidocaine application via chest tube before procedure. This study aimed at assessing the extent of effect of intrapleural lidocaine on pain during MT in a double-blind randomised trial. Results Thirty patients (mean age 48.3 years) were recruited, 14 randomised to the lidocaine group and 16 to the saline group. In four patients (two from each group), chest tube insertion prior to MT failed, and they were excluded from the final analysis. The mean (SD) visual analogue scale (VAS) pain score during procedure was 49 ± 33.2 for the lidocaine group and 57.4 ± 27.6 for the control group (mean difference − 8.4 points, p = 0.49). The VAS pain score as assessed by operator was 45.6 ± 19.8 for the lidocaine group and 46.6 ± 29.8 for the control group (p = 0.97). There was no difference in the VAS pain score at 120 min post MT or in the doses of sedatives used during procedure between the study groups. Conclusion ICA for MT does not seem to improve procedural pain as suggested by previous studies. Trial registration The study has been registered with the Pan African Clinical Trial Registry (PACTR202008762D159889).

scholarly journals Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Barthel Index ◽  
Controlled Trial ◽  
Survival Rates ◽  
Control Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

scholarly journals Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035610 ◽  
Author(s):  
Lucas Ogura Dantas ◽  
Ana Elisa Serafim Jorge ◽  
Paula Regina Mendes da Silva Serrão ◽  
Francisco Aburquerque-Sendín ◽  
Tania de Fatima Salvini
Keyword(s):  
Knee Osteoarthritis ◽  
Short Form ◽  
Randomised Trial ◽  
Unmet Need ◽  
Residual Effects ◽  
Control Group ◽  
Therapeutic Exercise ◽  
Exercise Protocol ◽  
Double Blind ◽  
Intention To Treat

IntroductionThere is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA.Methods and analysisThis study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test.Ethics and disseminationThe trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals.Trial registration numberNCT03360500

scholarly journals The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Joscha Reinhard ◽  
Swati Peiffer ◽  
Nicole Sänger ◽  
Eva Herrmann ◽  
Juping Yuan ◽  
...  
Keyword(s):  
Medical Care ◽  
Success Rate ◽  
Controlled Trial ◽  
Randomised Trial ◽  
External Cephalic Version ◽  
Control Group ◽  
Amniotic Fluid Index ◽  
Double Blind ◽  
Standard Medical Care ◽  
Clinical Hypnosis

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group.Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7(259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone ().Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (), successful ECV, whereas 38 women, who received NLP, had a 44.7% () successful ECV (). The control group had similar patient characteristics compared to the intervention groups (). In the control group () 27.3% () had a statistically significant lower successful ECV procedure than NLP () and hypnosis and NLP ().Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

scholarly journals Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ziyan Li ◽  
Yanzhe Ning ◽  
Pei Chen ◽  
Yi Zhang ◽  
Dongqing Yin ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Complete Blood Count ◽  
Controlled Trial ◽  
First Episode ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

scholarly journals Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yi Zhang ◽  
Yajun Gao ◽  
Jing Qin ◽  
Xiaoting Li ◽  
Fei Jiang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Reaction Rates ◽  
Needle Aspiration ◽  
Healing Time ◽  
Control Group ◽  
Cure Rate ◽  
Control Groups ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

scholarly journals Fluoxetine for Anterior Ischemic Optic Neuropathy (AION); a Double Blind Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Hossein Abbasi ◽  
Shahnaz Rimaz ◽  
Zahra Pourmousa ◽  
Leila Janani ◽  
Mostafa Soltan Sanjari
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Optic Neuropathy ◽  
Study Groups ◽  
Anterior Ischemic Optic Neuropathy ◽  
Control Group ◽  
Ischemic Optic Neuropathy ◽  
Double Blind ◽  
Clinical Prognosis ◽  
Before And After

Abstract Background: Fluoxetine enhances the levels of brain-derived neurotrophic factor (BDNF); considering its known improving effects on neurogenesis and plasticity, it seems to improve the Anterior Ischemic Optic Neuropathy (AION). This study aimed to evaluate the effect of Fluoxetine on clinical prognosis of patients with AION.Methods: In this double-blind placebo-controlled randomized clinical trial, subjects with AION who were referred to Rasool Akram Hospital were divided into two study groups; the fluoxetine group that received 20 mg Fluoxetine daily(n=50) and the control group (n=50) that received placebo for a period of six months. Patients underwent clinical and paraclinical evaluations before and after the trial. This study was a registered trial with IRCT code IRCT20181109041596N1.Results: One hundred patients were enrolled from August 2019 to December 2020 and assessed in this study. Subjects in Fluoxetine group showed significant improvement in visual acuity in comparison to the placebo group with less score in LogMAR scale (P: 0.008 and 0.002, respectively), improvement in MD parameters of perimetry (P: 0.003 and 0.002, respectively), and decrease in VEP latencies (P (in 1st minute): <0.001 and <0.001, P (in 15st minute): 0.038 and 0.011, respectively). There were no differences in color vision, Rnfl in all dimensions, PSD parameter of perimetry or VEP amplitudes following the trial of Fluoxetine therapy (Ps> 0.05).Conclusion: Fluoxetine showed promising therapeutic value for patients with AION besides its safety as an additive treatment option to corticosteroids.

scholarly journals Antipsychotics withdrawal in adults with intellectual disability and challenging behaviour: study protocol for a multicentre double-blind placebo-controlled randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sylvie Beumer ◽  
Pauline Hamers ◽  
Alyt Oppewal ◽  
Dederieke Maes-Festen
Keyword(s):  
Intellectual Disability ◽  
Side Effects ◽  
Psychiatric Disorders ◽  
Randomised Trial ◽  
Drop Out ◽  
Withdrawal Symptoms ◽  
Control Group ◽  
Challenging Behaviour ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background In people with intellectual disability (ID) and challenging behaviour, antipsychotics (AP) are often used off-label and for a long period. Despite a lack of evidence for efficacy for challenging behaviour and concerns about common and clinically relevant side effects, complete withdrawal often fails. We postulate three possible hypotheses for withdrawal failure: 1. Influence of subjective interpretation of behavioural symptoms by caregivers and family; 2. Beneficial effects from AP treatment on undiagnosed psychiatric illness, through improvement in sleep or a direct effect on behaviour; and 3. Misinterpretation of withdrawal symptoms as a recurrence of challenging behaviour. Methods To investigate our hypotheses, we have designed a multicentre double-blind, placebo-controlled randomised trial in which AP (pipamperone or risperidone) are withdrawn. In the withdrawal group, the AP dose is reduced by 25% every 4 weeks and in the control group the dose remains unaltered. Behaviour, sleep, psychiatric disorders, withdrawal symptoms and side effects will be measured and compared between the two groups. If drop-out from the protocol is similar in both groups (non-inferiority), the first hypothesis will be supported. If drop-out is higher in the withdrawal group and an increase is seen in psychiatric disorders, sleep problems and/or behavioural problems compared to the control group, this suggests effectiveness of AP, and indications for AP use should be reconsidered. If drop-out is higher in the withdrawal group and withdrawal symptoms and side effects are more common in the withdrawal group compared to the control group, this supports the hypothesis that withdrawal symptoms contribute to withdrawal failure. Discussion In order to develop AP withdrawal guidelines for people with ID, we need to understand why withdrawal of AP is not successful in the majority of people with ID and challenging behaviour. With this study, we will bridge the gap between the lack of available evidence on AP use and withdrawal on the one hand and the international policy drive to reduce prescription of AP in people with ID and challenging behaviour on the other hand. Trial registration This trial is registered in the Netherlands Trial Register (NTR 7232) on October 6, 2018 (www.trialregister.nl).

The use of Preoperative Lidocaine to Prevent Stridor and Laryngospasm after Tonsillectomy and Adenoidectomy

1998 ◽  
Vol 118 (6) ◽  
pp. 880-882 ◽  
Author(s):  
CAN KOÇ ◽  
FALIH KOCAMAN ◽  
ERDINÇ AYGENÇ ◽  
CAFER ÖZDEM ◽  
ALI ÇEKIÇ
Keyword(s):  
Early Postoperative Period ◽  
Control Group ◽  
Double Blind Study ◽  
Intravenous Lidocaine ◽  
Double Blind ◽  
Lidocaine Group ◽  
Group 4 ◽  
Topical Lidocaine ◽  
Plasma Lidocaine ◽  
Sedation Scores

The most important complications from tonsillectomy and adenoidectomy are bleeding, stridor, and laryngospasm. This controlled, double-blind study was designed to investigate the effects of topical and intravenous lidocaine on stridor and laryngospasm. A total of 134 patients scheduled for elective tonsillectomy and/or adenoidectomy were randomly separated into four groups. In the topical lidocaine group 4 mg/kg of 2% lidocaine was applied to subglottic, glottic, and supraglottic areas before endotracheal intubation. Normal saline solution was used topically for the first control group. In the intravenous lidocaine group, patients were given 1 mg/kg of 2% lidocaine before extubation, and the same amount of 0.9% NaCl was given to the second control group. Postoperative stridor, laryngospasm, cyanosis, bleeding, sedation degree, and respiratory depression were observed, and plasma lidocaine levels were measured. Both topical and intravenous lidocaine groups revealed less stridor and laryngospasm than the control groups, and no difference was found between the topical and intravenous lidocaine groups except the higher sedation scores in the early postoperative period for the intravenous lidocaine group. (Otolaryngol Head Neck Surg 1998;118:880–2.)

Does Epidural Anesthesia Have General Anesthetic Effects? 

1999 ◽  
Vol 91 (6) ◽  
pp. 1687-1687 ◽  
Author(s):  
Peter S. Hodgson ◽  
Spencer S. Liu ◽  
Troy W. Gras
Keyword(s):  
General Anesthesia ◽  
Epidural Anesthesia ◽  
Controlled Trial ◽  
Saline Control ◽  
Control Group ◽  
Double Blind ◽  
Lidocaine Group ◽  
Group I ◽  
End Tidal ◽  
Volatile Agents

Background Clinically, patients require surprisingly low end-tidal concentrations of volatile agents during combined epidural-general anesthesia. Neuraxial anesthesia exhibits sedative properties that may reduce requirements for general anesthesia. The authors tested whether epidural lidocaine reduces volatile anesthetic requirements as measured by the minimum alveolar concentration (MAC) of sevoflurane for noxious testing cephalad to the sensory block. Methods In a prospective, randomized, double-blind, placebo-controlled trial, 44 patients received 300 mg epidural lidocaine (group E), epidural saline control (group C), or epidural saline-intravenous lidocaine infusion (group I) after premedication with 0.02 mg/kg midazolam and 1 microg/kg fentanyl. Tracheal intubation followed standard induction with 4 mg/kg thiopental and succinylcholine 1 mg/kg. After 10 min or more of stable end-tidal sevoflurane, 10 s of 50 Hz, 60 mA tetanic electrical stimulation were applied to the fifth cervical dermatome. Predetermined end-tidal sevoflurane concentrations and the MAC for each group were determined by the up-and-down method and probit analysis based on patient movement. Results MAC of sevoflurane for group E, 0.52+/-0.18% (+/- 95% confidence interval [CI]), differed significantly from group C, 1.18+/-0.18% (P &lt; 0.0005), and from group I, 1.04+/-0.18% (P &lt; 0.001). The plasma lidocaine levels in groups E and I were comparable (2.3+/-1.0 vs. 3.0+/-1.2 microg/ml +/- SD). Conclusions Lidocaine epidural anesthesia reduced the MAC of sevoflurane by approximately 50%. This MAC sparing is most likely caused by indirect central effects of spinal deafferentation and not to systemic effects of lidocaine or direct neural blockade. Thus, lower concentrations of volatile agents than those based on standard MAC values may be adequate during combined epidural-general anesthesia.

Managing irritable bowel syndrome: The impact of micro-physiotherapy

2017 ◽  
Vol 14 (2) ◽  
Author(s):  
Daniel Grosjean ◽  
Patrice Benini ◽  
Pierre Carayon
Keyword(s):  
Irritable Bowel Syndrome ◽  
Holistic Approach ◽  
Study Groups ◽  
Control Group ◽  
Double Blind Study ◽  
Self Healing ◽  
Double Blind ◽  
Significant Difference ◽  
Irritable Bowel ◽  
The Impact

AbstractBackgroundIrritable bowel syndrome (IBS) has a complex pathology, high prevalence and large impact on patients’ quality of life. As conventional therapy may yield unsatisfactory results, a more holistic approach may be desirable. The current study assessed the effect of micro-physiotherapy on the severity of IBS symptoms.MethodsIn a double-blind study, 61 recurrent IBS patients were randomised to two sessions of micro-physiotherapy or sham micro-physiotherapy. Inclusion criteria were the presence of ≥1 IBS symptom from abdominal pain, constipation, diarrhoea or bloating. Exclusion criteria were previous major intestinal surgery and the presence of chronic diseases. The mean patient age was 53.5±15.3 years. Micro-physiotherapy consisted of micro-palpatory examination to identify osteopathic lesions, followed by micro-massage to stimulate self-healing. The control group underwent a sham procedure. The presence and severity of symptoms was assessed at baseline and at 1-month follow-up by the same gastroenterologist.ResultsTwo patients did not complete the study. There was a significant difference in percentage of patients that improved after the first session, at 74 % for the micro-physiotherapy group and 38 % for the sham group, respectively (p=0.005). After the second session, the initial improvement was maintained in both groups, although with no further gains, and the differences between the study groups remained significant (p=0.007).ConclusionsMicro-physiotherapy significantly improves IBS symptoms and should be explored further for use in mainstream healthcare.

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