scholarly journals Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maciej Kaszyński ◽  
Dorota Lewandowska ◽  
Piotr Sawicki ◽  
Piotr Wojcieszak ◽  
Izabela Pągowska-Klimek
Keyword(s):  
Laparoscopic Appendectomy ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Intravenous Lidocaine ◽  
Lidocaine Group ◽  
Randomized Controlled ◽  
Fentanyl Consumption

Abstract Intravenous lidocaine, a potent local anesthetic with analgesic and anti-inflammatory properties, has been shown to be an effective adjunct that reduces intra- and postoperative opioid consumption and facilitates pain management in adults. While it shows promise for use in the pediatric population, limited evidence is available. Objectives To determine if general anesthesia with intraoperative intravenous lidocaine infusion versus general anesthesia without intravenous lidocaine infusion in children undergoing laparoscopic appendectomy decreased opioid requirements intra- and postoperatively. Design A single-center parallel single-masked randomized controlled study. A computer-generated blocked randomization list was used to allocate participants. The study was conducted between March 2019 and January 2020. Setting: Pediatric teaching hospital in Poland. Participants Seventy-four patients aged between 18 months and 18 years undergoing laparoscopic appendectomy. Seventy-one patients fulfilled the study requirements. Intervention Intravenous lidocaine bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively. The infusion was discontinued before the patients’ transfer to the postanesthesia care unit (PACU). Primary outcome measure The primary outcome measure was total nalbuphine requirement in milligrams during the first 24 h after surgery. Secondary outcome measures The secondary outcome measures were intraoperative fentanyl consumption, intraoperative sevoflurane consumption, time to the first rescue analgesic request, incidence of postoperative nausea and vomiting during the first 24 h after surgery, frequency of side effects of lidocaine. Results Children (n = 74) aged 5–17 randomly allocated to receive intraoperative lidocaine infusion (n = 37) or no intervention (n = 37). Seventy-one were included in the analysis (35 in the study group and 36 in the control group). There was no difference in the cumulative dose of nalbuphine in the first 24 h after removal of the endotracheal tube between groups [median of 0.1061 (IQR: 0.0962–0.2222) mg/kg in the lidocaine group, compared to the control group median of 0.1325 (IQR: 0.0899–0.22020) mg/kg, p = 0.63]. Intraoperative fentanyl consumption was lower in the lidocaine group [median of 5.091 (IQR: 4.848–5.714) μg/kg] than in the control group [median of 5.969 (IQR: 5.000–6.748), p = 0.03]. Taking into account the additional doses administered based on clinical indications, the reduction in the requirement for fentanyl in the lidocaine group was even greater [median of 0.0 (IQR: 0.0–0.952) vs 0.99 (IQR: 0.0–1.809) μg/kg, p = 0.01]. No difference was observed in the sevoflurane consumption between the two groups [median of 32.5 ml (IQR 25.0–43.0) in the lidocaine group vs median of 35.0 ml (IQR: 23.5–46.0) in the control group, p = 0.56]. The time to first analgesic request in the lidocaine group was prolonged [median of 55 (IQR: 40–110) min in the lidocaine group vs median of 40.5 (IQR: 28–65) min in the control group, p = 0.05]. There was no difference in the frequency of PONV between the two groups (48.57% in the lidocaine group vs 61.11% in the control group, p = 0.29). No lidocaine related incidence of anaphylaxis, systemic toxicity, circulatory disturbances or neurological impairment was reported, during anesthesia or postoperative period. Conclusions Intraoperative systemic lidocaine administration reduced the intraoperative requirement for opioids in children undergoing laparoscopic appendectomy. This effect was time limited, and hence did not affect opioid consumption in the first 24 h following discontinuation of lidocaine infusion. Trial registration NCT03886896.

Walking and talking therapy: Improving cognitive–motor dual-tasking in neurological illness

2009 ◽  
Vol 15 (1) ◽  
pp. 112-120 ◽  
Author(s):  
JONATHAN J. EVANS ◽  
EVE GREENFIELD ◽  
BARBARA A. WILSON ◽  
ANDREW BATEMAN
Keyword(s):  
Training Program ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Daily Practice ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Trial Methodology ◽  
Dual Tasking ◽  
Questionnaire Measure

AbstractUsing randomized control trial methodology, we evaluated the effectiveness of a 5-week cognitive–motor dual-tasking training program developed to improve performance of a group of people with dual-tasking difficulties arising from acquired brain injury. Training involved twice-daily practice on exercises involving walking being combined with tasks which increased in cognitive demand over the course of the intervention. A treatment group (n = 10) was compared with a control group (n = 9). The primary outcome measure was a task requiring participants to walk and carry out a spoken sentence verification task simultaneously. Secondary outcome measures were measures of dual-tasking involving either two motor tasks or two cognitive tasks. A questionnaire measure relating to activities of daily living requiring dual-tasking was also completed. Compliance with the training program was good. We found evidence of improvement in performance on the primary outcome measure, but little evidence of generalization to other measures. There was some evidence that participants believed that their dual-tasking performance in everyday life was improved after the intervention. The study was limited in terms of sample size, was not blinded and did not control fully for therapist contact time, but has produced valuable data relating to effect sizes associated with this form of intervention. (JINS, 2009, 15, 112–120.)

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Anterior Circulation ◽  
Guide Catheter ◽  
Catheter Failure ◽  
Catheter Technology ◽  
Intracranial Vasculature

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

scholarly journals Association between workarounds and medication administration errors in bar-code-assisted medication administration in hospitals

2017 ◽  
Vol 25 (4) ◽  
pp. 385-392 ◽  
Author(s):  
Willem van der Veen ◽  
Patricia MLA van den Bemt ◽  
Hans Wouters ◽  
David W Bates ◽  
Jos WR Twisk ◽  
...  
Keyword(s):  
Prospective Observational Study ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Medication Administration ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Bar Code ◽  
Implementation Evaluation ◽  
Medication Administration Errors ◽  
Large Numbers

Abstract Objective To study the association of workarounds with medication administration errors using barcode-assisted medication administration (BCMA), and to determine the frequency and types of workarounds and medication administration errors. Materials and Methods A prospective observational study in Dutch hospitals using BCMA to administer medication. Direct observation was used to collect data. Primary outcome measure was the proportion of medication administrations with one or more medication administration errors. Secondary outcome was the frequency and types of workarounds and medication administration errors. Univariate and multivariate multilevel logistic regression analysis were used to assess the association between workarounds and medication administration errors. Descriptive statistics were used for the secondary outcomes. Results We included 5793 medication administrations for 1230 inpatients. Workarounds were associated with medication administration errors (adjusted odds ratio 3.06 [95% CI: 2.49-3.78]). Most commonly, procedural workarounds were observed, such as not scanning at all (36%), not scanning patients because they did not wear a wristband (28%), incorrect medication scanning, multiple medication scanning, and ignoring alert signals (11%). Common types of medication administration errors were omissions (78%), administration of non-ordered drugs (8.0%), and wrong doses given (6.0%). Discussion Workarounds are associated with medication administration errors in hospitals using BCMA. These data suggest that BCMA needs more post-implementation evaluation if it is to achieve the intended benefits for medication safety. Conclusion In hospitals using barcode-assisted medication administration, workarounds occurred in 66% of medication administrations and were associated with large numbers of medication administration errors.

scholarly journals A Sternum-Disk Distance Method to Identify the Skin Level for Approaching a Surgical Segment without Fluoroscopy Guidance during Anterior Cervical Discectomy And Fusion

2017 ◽  
Vol 11 (1) ◽  
pp. 50-56
Author(s):  
Gun Woo Lee ◽  
Myun-Whan Ahn ◽  
Ji-Hoon Shin ◽  
Jae Woo Park ◽  
Jae-Hyung Uh ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Kappa Coefficient ◽  
Anterior Cervical Discectomy ◽  
Secondary Outcome ◽  
Distance Method ◽  
Cervical Discectomy ◽  
Observer Reliability ◽  
The Mean

<sec><title>Study Design</title><p>A retrospective review of prospectively collected data.</p></sec><sec><title>Purpose</title><p>To introduce the sternum-disk distance (SDD) method for approaching the exact surgical level without C-arm guidance during anterior cervical discectomy and fusion (ACDF) surgery and to evaluate its accuracy and reliability.</p></sec><sec><title>Overview of Literature</title><p>Although spine surgeons have tried to optimize methods for identifying the skin level for accessing the operative disk level without C-arm guidance during ACDF, success has rarely been reported.</p></sec><sec><title>Methods</title><p>In total, 103 patients who underwent single-level ACDF surgery with the SDD method were enrolled. The primary outcome measure was the accuracy of the SDD method. The secondary outcome measures were the mean SDD value at each cervical level from the cranial margin of the sternum in the neutral and extension positions of the cervical spine and the inter- and intra-observer reliability of the SDD outcome determined using repeated measurements by three orthopedic spine surgeons.</p></sec><sec><title>Results</title><p>The SDD accuracy (primary outcome measure) was indicated in 99% of the patients (102/103). The mean SDD values in the neutral-position magnetic resonance imaging (MRI) were 108.8 mm at C3–C4, 85.3 mm at C4–C5, 64.4 mm at C5–C6, 44.3 mm at C6–C7, and 24.1 mm at C7–T1; and those in the extension-position MRI were 112.9 mm at C3–C4, 88.7 mm at C4–C5, 67.3 mm at C5–C6, 46.5 mm at C6–C7, and 24.3 mm at C7–T1. The Cohen kappa coefficient value for intra-observer reliability was 0.88 (excellent reliability), and the Fleiss kappa coefficient value for inter-observer reliability as reported by three surgeons was 0.89 (excellent reliability).</p></sec><sec><title>Conclusions</title><p>Based on the results of the present study, we recommend performing ACDF surgery using the SDD method to determine the skin level for approaching the surgical cervical segment without fluoroscopic guidance.</p></sec>

scholarly journals Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Camille Champigny ◽  
Florence Morin-Parent ◽  
Laurence Bellehumeur-Lefebvre ◽  
Artuela Çaku ◽  
Jean-François Lepage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fragile X Syndrome ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Fragile X ◽  
Combined Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

scholarly journals 188 The Use of a Group Based Upper Limb Programme in Improving Outcome in Acute Stroke Rehabilitation

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Kerri Donnelly ◽  
Enya Mulcahy ◽  
Catherine Merrick ◽  
Orla Fitzgerald
Keyword(s):  
Acute Stroke ◽  
Grip Strength ◽  
Outcome Measures ◽  
Upper Limb ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dominant Hand ◽  
Nine Hole Peg Test

Abstract Background After a stroke 85% of patients experience altered arm function. Current research demonstrates that increasing upper limb rehabilitation results in improved outcomes (Ward et al., 2019). The Graded Repetitive Arm Supplementary Programme (GRASP) group is an established adjunctive therapy in the stroke service. The group provides additional therapy for suitable patients with upper extremity deficits. The group is run jointly by a physiotherapist and an occupational therapist. Patients attend twice weekly for a one hour period in addition to their regular therapy. The GRASP group consists of 3 levels of varying abilities and patients are categorised by their Fugl-Meyer score. Methods A prospective audit was completed in 2019 and data was collected using a word document and excel spread sheet. Standardised outcome measures were completed on admission and discharge to establish upper limb ability. The primary outcome measure was the Fugl-Meyer and the secondary outcome measures were the nine hole peg test and grip strength using the Dynamometer. Results 12 patients attended the GRASP group over this period. 75% were males. The average age was 76 years with the age range from 48-95 years. 58% of patients experienced upper limb weakness in their non-dominant hand. Post intervention data was not obtained for 5 patients due to unforeseeable discharge from the acute setting. Preliminary data to date shows that our primary outcome measure improved in 86% of patients with increases ranging from 2-11 points on the Fugl-Meyer score (Minimally Clinical Important Difference =5points). Our secondary outcome measures demonstrated patients had no change (28%) or an improvement (72%) in grip strength and 100% of patients improved on the time taken to complete the nine hole peg test. Conclusion The GRASP group was found to be effective in improving upper limb outcome measures in an acute stroke inpatient hospital setting.

scholarly journals Prognostic value of reduction in left atrial size during a follow-up of heart failure: an observational study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044409
Author(s):  
Masayuki Shiba ◽  
Takao Kato ◽  
Takeshi Morimoto ◽  
Hidenori Yaku ◽  
Yasutaka Inuzuka ◽  
...  
Keyword(s):  
Heart Failure ◽  
Lower Risk ◽  
Left Atrial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
No Reduction ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Group Change

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change <0 mm) (n=398) and the no-reduction in the LAD group (change ≥0 mm) (n=275).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

Hypokalemia Measurement and Management in Patients With Status Asthmaticus on Continuous Albuterol

2022 ◽  
Author(s):  
Courtney Cox ◽  
Krishna Patel ◽  
Rebecca Cantu ◽  
Chary Akmyradov ◽  
Katherine Irby
Keyword(s):  
Potassium Level ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Status Asthmaticus ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Treatment Frequency ◽  
Care Costs

OBJECTIVE: Status asthmaticus is commonly treated in pediatric patients by using continuous albuterol, which can cause hypokalemia. The primary aim of this study was to determine if serial potassium monitoring is necessary by examining treatment frequency of hypokalemia. METHODS: This retrospective analysis was performed in 185 pediatric patients admitted with status asthmaticus requiring continuous albuterol between 2017 and 2019. All patients were placed on intravenous fluids containing potassium. The primary outcome measure was the treatment of hypokalemia in relation to the number of laboratory draws for potassium levels. The secondary outcome measure was hypokalemia frequency and relation to the duration and initial dose of continuous albuterol. RESULTS: Included were 156 patients with 420 laboratory draws (average, 2.7 per patient) for potassium levels. The median lowest potassium level was 3.40 mmol/L (interquartile range, 3.2–3.7). No correlation was found between initial albuterol dose and lowest potassium level (P = .52). Patients with hypokalemia had a mean albuterol time of 12.32 (SD, 15.76) hours, whereas patients without hypokalemia had a mean albuterol time of 11.50 (SD, 12.53) hours (P = .29). Potassium levels were treated 13 separate times. CONCLUSIONS: The number of laboratory draws for potassium levels was high in our cohort, with few patients receiving treatment for hypokalemia beyond the potassium routinely added to maintenance fluids. Length of time on albuterol and dose of albuterol were not shown to increase the risk of hypokalemia. Serial laboratory measurements may be decreased to potentially reduce health care costs, pain, and anxiety surrounding needlesticks.

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