scholarly journals Intrathecal Baclofen in Spinal Spasticity: Frequency and Severity of Withdrawal Syndrome

2015 ◽  
Vol 18;4 (4;18) ◽  
pp. E633-E641 ◽  
Author(s):  
Ivana Stetkarova
Keyword(s):  
Withdrawal Syndrome ◽  
Small Sample Size ◽  
Medical Center ◽  
Academic Medical Center ◽  
Intrathecal Baclofen ◽  
Small Sample ◽  
Serious Adverse Events ◽  
Pump Failure ◽  
Long Term Treatment ◽  
Cord Injury

Background: Intrathecal baclofen (ITB) delivered by programmable pump devices represents an important modality for long-term treatment of severe spinal spasticity. Objective: One of the serious adverse events is a withdrawal syndrome after sudden interruption of ITB delivery. In this study, we analyzed the frequency and severity of this complication. Treatment recommendations follow. Study Design: Case study Setting: Academic medical center. Methods: A total of 54 ITB pumps were successfully implanted in 39 patients with severe intractable spasticity (24 with spinal cord injury, 15 with multiple sclerosis, 24 men, age range 21 – 59 years). Results: Eight patients developed a withdrawal syndrome on total a daily dose of ITB between 90 – 420 µg/day. Seven patients had catheter-related complications. In one patient, pump failure was observed due to its corrosion. Within the group, baclofen withdrawal syndrome occurred once in 20.1 pump-years counted out of 160.4 pump-years of ITB treatment. Limitations: Small sample size. Conclusions: ITB withdrawal syndrome is a rare but life-threatening event and prompt diagnosis before treatment initiation is critical. The reported events were mostly mild due to the acute treatment regime and probably due to a lower dose of ITB. A prerequisite for successful ITB treatment is a deep knowledge of complications and their prompt management in the hands of a multidisciplinary team in specialized centers. Key words: Spasticity, intrathecal baclofen, pump systems, complications, withdrawal syndrome

Abstract 248: Initiation and Assessment of Timekeeping Roles During In-Hospital Cardiac Arrests to Track Rhythm Checks and Epinephrine Dosing

Circulation ◽  
2019 ◽  
Vol 140 (Suppl_2) ◽  
Author(s):  
Conor Crowley ◽  
Peter Clardy ◽  
Jessica McCannon ◽  
Rebecca Logiudice
Keyword(s):  
Small Sample Size ◽  
Medical Center ◽  
Academic Medical Center ◽  
Small Sample ◽  
Post Intervention ◽  
Epinephrine Administration ◽  
Team Members ◽  
Minute Post ◽  
Chaotic Nature ◽  
Strongly Agree

Introduction: Compliance to ACLS cardiac arrest algorithm is low and associated with worse outcomes from in-hospital cardiac arrests (IHCA). Reasons for non-compliance include reduced communication due to chaotic nature of IHCAs and difficulty timing epinephrine administration and rhythm check intervals. Hypothesis: Delegating two separate code team members for rhythm and epinephrine timing will increase adherence to ACLS algorithm during IHCAs. Methods: This is a pre-post interventional study of IHCAs at a single academic medical center. Two stopwatches were placed on all code carts and two new timekeeping roles were created. Education was provided to staff regarding the alteration of existing code team member roles for the use of stopwatches. Algorithm adherence was analyzed pre and post implementation of timekeeper roles. Deviation from the 2-minute rhythm check or 3-5-minute epinephrine administration was counted as one deviation. Anonymous surveys were delivered to evaluate providers perceived benefits of timekeeper roles for IHCAs. Results: Data from 13 pre intervention IHCAs were compared to 12 IHCAs post intervention. The initial rhythm was PEA/asystole in 69% pre-intervention vs 83% post intervention. Prior to implementation 82 deviations vs. 11 deviations post implementation occurred (p=0.006). The mean time until first dose of epinephrine was administered pre intervention was 2.3 ± 3.3 minutes vs 0.4 ±1 minute post. Pre-implementation ROSC rate was 53.8% vs. 66.7% post intervention. Surveys were delivered to 100% of code team members post intervention, with a 79% response rate. Surveys demonstrate providers felt time keeping roles made it easier to track epinephrine administration and rhythm checks. On a Likert scale, 78% of providers “strongly agree” that the use of timekeeping roles and devices improved code team communication. Conclusion: Two separate timekeeper roles during IHCAs improved algorithm compliance, code team function and communication, and was favored by code team members. Timekeeper roles may be associated with improved rates of ROSC and less time until the first dose of epinephrine is administered. This study is limited by its small sample size, single center and requires validation.

scholarly journals Perioperative, Single-Surgeon Experience in Cerebrovascular Bypass Procedures at Academic Medical Center and Community Hospital

2018 ◽  
Vol 05 (03) ◽  
pp. 173-176
Author(s):  
Kathleen W. Nissman ◽  
Ali R. Zomorodi ◽  
Dhanesh K. Gupta ◽  
Ishwori Dhakal ◽  
Yi-Ju Li ◽  
...  
Keyword(s):  
Community Hospital ◽  
Small Sample Size ◽  
Medical Center ◽  
Academic Medical Center ◽  
Small Sample ◽  
Neurosurgical Procedures ◽  
Academic Medical ◽  
Tertiary Center ◽  
Significant Difference ◽  
Surgeon Experience

Abstract Background Little evidence exists for superiority of neurosurgical outcomes from care subspecialization. Outcomes of a single neurosurgeon after complex vascular neurosurgery in an academic medical center were compared against those in a community hospital. Methods In this retrospective analysis of extracranial-intracranial vascular bypass operations performed between July 1, 2013 and February 1, 2015, cases were identified by cross-referencing the electronic medical record with the surgeon's own records. Pre-, intra-, and postoperative variables were abstracted from cases performed at a tertiary center and a community hospital. Dichotomous postoperative data recorded included extubation in the operating room (OR), readmission, and survival to discharge, and length of stay was also analyzed. Due to small sample size and low readmission rate, Firth's penalized likelihood tests were incorporated in the logistic regression model for parameter estimation and testing. Results A total of 28 hemispheres in 26 patients were included: 18 hemispheres in 16 patients at the tertiary center and 10 hemispheres in 9 patients at the community hospital. Differences were found in operative time (tertiary mean: 7.21 + 2.5 hours, community mean: 5.19 + 0.9 hours, p = 0.0074) and readmission to the tertiary center (p = 0.078). However, significant difference was observed only for anesthetic type (more likely to include remifentanil and propofol at the tertiary center, p = 0.0104). Conclusion Subspecialty care alone may be insufficient to enhance outcome after complex neurosurgical procedures.

Initiation of Buprenorphine/Naloxone on Rates of Discharge Against Medical Advice

2020 ◽  
pp. 001857872098543
Author(s):  
Lindsey B. Kays ◽  
Emily D. Steltenpohl ◽  
Chelsey M. McPheeters ◽  
Emily K. Frederick ◽  
Laura B. Bishop
Keyword(s):  
Small Sample Size ◽  
Medical Center ◽  
Academic Medical Center ◽  
Small Sample ◽  
Medical Advice ◽  
Opioid Use ◽  
Opioid Agonist ◽  
Against Medical Advice ◽  
Objective Evidence ◽  
Discharge Against Medical Advice

Objective: Evidence shows that patients with opioid use disorder (OUD) have an increased rate of discharge against medical advice (DAMA) as well as higher rates of hospital readmission. Therefore, the objective of this study was to determine if inpatient initiation of buprenorphine/naloxone in patients with OUD is associated with decreased rates of DAMA. Methods: This was a single center retrospective cohort study conducted at a level 1, academic medical center. The study included patients with OUD admitted to the Internal Medicine service from January through May of both 2018 and 2019 for an admitting diagnosis other than opioid withdrawal. The primary endpoint was rate of DAMA among OUD patients not initiated on opioid agonist therapy compared to those initiated on buprenorphine/naloxone. The secondary endpoint was the association between factors of the initiation process on rates of DAMA. Patients were excluded if they were discharged in less than 24 hours or received intermittent administration of buprenorphine/naloxone. Results: The rate of DAMA in OUD patients not initiated on buprenorphine/naloxone was 13.85% compared to 2.56% in those initiated on buprenorphine/naloxone ( P = .048). Conclusion: In OUD patients initiated on buprenorphine/naloxone, the rate of DAMA was significantly lower than those who were not. This data supports the importance of optimizing the opportunity to initiate buprenorphine/naloxone in the acute care setting to minimize withdrawal symptoms therefore reducing the rate of DAMA. Ultimately increasing the ability to adequately treat the primary reason for admission and potentially decreasing readmission rates. Further studies are needed to evaluate this impact as this study is limited to a small sample size therefore lacking adequate power.

scholarly journals Serial neuroimaging in infants with abusive head trauma: timing abusive injuries

2013 ◽  
Vol 12 (2) ◽  
pp. 110-119 ◽  
Author(s):  
Ray Bradford ◽  
Arabinda K. Choudhary ◽  
Mark S. Dias
Keyword(s):  
Head Trauma ◽  
Small Sample Size ◽  
Medical Center ◽  
Abusive Head Trauma ◽  
Time Frame ◽  
Small Sample ◽  
Ct Scans ◽  
Imaging Studies ◽  
T1 Hyperintensity ◽  
Clinical Records

Object The appearance and evolution of neuroimaging abnormalities following abusive head trauma (AHT) is important for establishing the time frame over which these injuries might have occurred. From a legal perspective this frames the timing of the abuse and therefore identifies and excludes potential perpetrators. A previous pilot study involving 33 infants with AHT helped to refine the timing of these injuries but was limited by its small sample size. In the present study, the authors analyzed a larger group of 210 cases involving infants with AHT to chronicle the first appearance and evolution of radiological (CT, MRI) abnormalities. Methods All children younger than 24 months admitted to the Penn State Hershey Medical Center with AHT over a 10-year period were identified from a medical record review; the time of injury was determined through an evaluation of the clinical records. All imaging studies were analyzed, and the appearance and evolution of abnormalities were chronicled on serial neuroimaging studies obtained in the days and weeks after injury. Results One hundred five infants with specific injury dates and available imaging studies were identified; a subset of 43 children additionally had documented times of injury. In infants with homogeneously hyperdense subdural hematomas (SDHs) on initial CT scans, the first hypodense component appeared within the SDH between 0.3 and 16 days after injury, and the last hyperdense subdural component disappeared between 2 and 40 days after injury. In infants with mixed-density SDHs on initial scans, the last hyperdense component disappeared between 1 and 181 days. Parenchymal hypodensities appeared on CT scans performed as early as 1.2 hours, and all were visible within 27 hours after the injury. Rebleeding into SDHs was documented in 17 cases (16%) and was always asymptomatic. Magnetic resonance imaging of the brain was performed in 49 infants. Among those with SDH, 5 patterns were observed. Patterns I and II reflected homogeneous SDH; Pattern I (T1 hyperintensity and T2/FLAIR hypointensity, “early subacute”) more commonly appeared on scans performed earlier after injury compared with Pattern II (T1 hyperintensity and T2/FLAIR hyperintensity, “late subacute”), although there was considerable overlap. Patterns III and IV reflected heterogeneous SDH; Pattern III contained relatively equal mixtures having different intensities, whereas Pattern IV had fluid that was predominantly T1 hypointense and T2/FLAIR hyperintense. Again, Pattern III more commonly appeared on scans performed earlier after injury compared with Pattern IV, although there was significant overlap. Conclusions These data extend the preliminary data reported by Dias and colleagues and provide a framework upon which injuries in AHT can be timed as well as the limitations on such timing estimates.

scholarly journals A Pilot Placebo Controlled Randomized Trial of Dexamethasone for Chronic Subdural Hematoma

2016 ◽  
Vol 43 (2) ◽  
pp. 284-290 ◽  
Author(s):  
Michel Prud’homme ◽  
François Mathieu ◽  
Nicolas Marcotte ◽  
Sylvine Cottin
Keyword(s):  
Conservative Treatment ◽  
Adverse Events ◽  
Small Sample Size ◽  
Chronic Subdural Hematoma ◽  
Symptomatic Patient ◽  
Placebo Treatment ◽  
Small Sample ◽  
Chi Square ◽  
Serious Adverse Events ◽  
Before And After

AbstractBackground: Current opinions regarding the use of dexamethasone in the treatment of chronic subdural hematomas (CSDH) are only based on observational studies. Moreover, the use of corticosteroids in asymptomatic or minimally symptomatic patient with this condition remains controversial. Here, we present data from a prospective randomized pilot study of CSDH patients treated with dexamethasone or placebo. Methods: Twenty patients with imaging-confirmed CSDH were recruited from a single center and randomized to receive dexamethasone (12 mg/day for 3 weeks followed by tapering) or placebo as a conservative treatment. Patients were followed for 6 months and the rate of success of conservative treatment with dexamethasone versus placebo was measured. Parameters such as hematoma thickness and clinical changes were also compared before and after treatment with chi-square tests. Adverse events and complications were documented. Results: During the 6-month follow-up, one of ten patients treated with corticosteroids had to undergo surgical drainage and three of ten patients were treated surgically after placebo treatment. At the end of the study, all remaining patients had complete radiological resolution. No significant differences were observed in terms of hematoma thickness profile and impression of change; however, patients experienced more severe side effects when treated with steroids as compared with placebo. Dexamethasone contributed to many serious adverse events. Conclusions: Given the small sample size, these preliminary results have not shown a clear beneficial effect of dexamethasone against placebo in our patients. However, the number of secondary effects reported was much greater for corticosteroids, and dexamethasone treatment was responsible for significant complications.

Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial

2021 ◽  
pp. bjophthalmol-2021-319067
Author(s):  
Felix Friedrich Reichel ◽  
Stylianos Michalakis ◽  
Barbara Wilhelm ◽  
Ditta Zobor ◽  
Regine Muehlfriedel ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Small Sample ◽  
Functional Improvement ◽  
Limiting Factor ◽  
Serious Adverse Events

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.

Long-Term Results of Radiofrequency Volumetric Tissue Reduction of the Palate for Snoring

2003 ◽  
Vol 112 (3) ◽  
pp. 276-279 ◽  
Author(s):  
Bassem Said ◽  
Marshall Strome
Keyword(s):  
Patient Satisfaction ◽  
Medical Center ◽  
Academic Medical Center ◽  
Term Treatment ◽  
Response To Treatment ◽  
Long Term Results ◽  
Long Term Treatment ◽  
Radiofrequency Volumetric Tissue Reduction ◽  
Tissue Reduction

To assess the long-term efficacy and morbidity of radiofrequency volumetric tissue reduction (RFVTR) of the soft palate for snoring, we examined the medical records of 39 patients who received this treatment at an academic medical center. Telephone interviews were conducted with the patients to evaluate the long-term subjective efficacy and sequelae. The average follow-up was 14 months (range, 3 to 26 months). Twenty-eight patients (72%) responded to treatment, defined as a 4-point decrease on a 10-point scale. The self-reported snoring score decreased an average of 52% (8.8 ± 1.9 to 4.2 ± 2.9). Sixty-seven percent of the patients were satisfied. The response to treatment did not always correlate with patient satisfaction. The snoring relapse rate was 11% among responders. No significant differences were identified between responders and nonresponders. No significant complications or long-term sequelae were observed. We conclude that RFVTR of the palate is a relatively safe and effective long-term treatment for snoring. Defining realistic pretreatment expectations is important in maximizing patient satisfaction.

Incidence of Surgical Site Infection Associated with Robotic Surgery

2010 ◽  
Vol 31 (8) ◽  
pp. 822-827 ◽  
Author(s):  
Elizabeth D. Hermsen ◽  
Tim Hinze ◽  
Harlan Sayles ◽  
Lee Sholtz ◽  
Mark E. Rupp
Keyword(s):  
Surgical Site Infection ◽  
Open Surgery ◽  
Small Sample Size ◽  
Academic Medical Center ◽  
Small Sample ◽  
Site Infection ◽  
National Data ◽  
Robot Assisted ◽  
Surgical Duration ◽  
Robot Assisted Surgery

Objective.Robot-assisted surgery is minimally invasive and associated with less blood loss and shorter recovery time than open surgery. We aimed to determine the duration of robot-assisted surgical procedures and the incidence of postoperative surgical site infection (SSI) and to compare our data with the SSI incidence for open procedures according to national data.Design.Retrospective cohort study.Setting.A 689-bed academic medical center.Patients.All patients who underwent a surgical procedure with use of a robotic surgical system during the period from 2000-2007.Methods.SSIs were defined and procedure types were classified according to National Healthcare Safety Network criteria. National data for comparison were from 1992-2004. Because of small sample size, procedures were grouped according to surgical site or wound classification.Results.Sixteen SSIs developed after 273 robot-assisted procedures (5.9%). The mean surgical duration was 333.6 minutes. Patients who developed SSI had longer mean surgical duration than did patients who did not (558 vs 318 minutes; P<.001). The prostate and genitourinary group had 5.74 SSIs per 100 robot-assisted procedures (95% confidence interval [CI], 2.81–11.37), compared with 0.85 SSIs per 100 open procedures from national data. The gynecologic group had 10.00 SSIs per 100 procedures (95% CI, 2.79–30.10), compared with 1.72 SSIs per 100 open procedures. The colon and herniorrhaphy groups had 33.33 SSIs per 100 procedures (95% CI, 9.68–70.00) and 37.50 SSIs per 100 procedures (95% CI, 13.68–69.43), respectively, compared with 5.88 and 1.62 SSIs per 100 open procedures from national data. Patients with a clean-contaminated wound developed 6.1 SSIs per 100 procedures (95% CI, 3.5–10.3), compared with 2.59 SSIs per 100 open procedures. No significant differences in SSI rates were found for other groups.Conclusions.Increased incidence of SSI after some types of robot-assisted surgery compared with traditional open surgery may be related to the learning curve associated with use of the robot.

Effect of coadministration of propranolol and etodolac (VT-122) plus sorafenib for patients with advanced hepatocellular carcinoma (HCC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 390-390 ◽  
Author(s):  
Andrew N de la Torre ◽  
Ismael Castaneda ◽  
Aram F. Hezel ◽  
Newell F. Bascomb ◽  
Gouri Shankar Bhattacharyya ◽  
...  
Keyword(s):  
Hepatitis Virus ◽  
Small Sample Size ◽  
Small Sample ◽  
Controlled Study ◽  
Advanced Hepatocellular Carcinoma ◽  
Separate Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Duration Of Therapy ◽  
Significant Efficacy

390 Background: Propranolol and etodolac (designated VT-122) target the adrenergic and prostaglandin stress systems activated in HCC. These stress-induced systems are proposed to induce changes in the tumor microenvironment and immune system leading to tumor promotion and immune tolerance. In a separate study, administration of VT-122 prior to sorafenib showed an increase in median overall survival (OS) of 21 months when VT-122 is administered before sorafenib compared to 10 months OS for sorafenib alone. The aim of the current study was to evaluate the effect of administering VT-122 at least 30 days after starting sorafenib. Methods: Patients with HCC receiving sorafenib for at least 30 days were eligible for this double-blind, placebo-controlled study. Patients were randomized to receive sorafenib with either VT-122 or placebo. Patients received therapy for up to 12 months or until treatment failure. VT-122 was administered twice daily. The primary endpoint was duration of therapy (DoT) and the secondary endpoint was OS. Results: Twenty patients were randomized, 11 and 9 patients to the VT122 and placebo arm, respectively. Each arm was balanced with regards to age (mean of 60.4 years), Child Pugh status (9 Child Pugh A, 11 Child Pugh B7), hepatitis virus status (6 HBV and 1 HCV positive) and C-reactive protein (CRP) (20.4 mg/L). VT122 with sorafenib was well tolerated with no unexpected serious adverse events reported. Mean OS was 13.9 months and 9.6 months in the VT-122 and placebo arms, respectively. Mean DoT (unvalidated) was 10.1 months and 7.5 months in the VT-122 and placebo arms, respectively. Conclusions: Co-administration of VT-122 with sorafenib was well tolerated and showed an increase in duration of therapy and OS versus sorafenib alone. The small sample size and number of events precludes the ability to make any significant efficacy conclusions. The increase in survival was not as great as that seen in a separate study in which VT122 was started prior to sorafenib. A further Phase 3 study of VT122 administered prior to sorafenib in patients with HCC is warranted. Clinical trial information: NCT01265576.

Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study

1993 ◽  
Vol 78 (2) ◽  
pp. 226-232 ◽  
Author(s):  
Robert J. Coffey ◽  
David Cahill ◽  
William Steers ◽  
T. S. Park ◽  
Joe Ordia ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Intrathecal Baclofen ◽  
Neurological Deficits ◽  
Pump System ◽  
Postoperative Score ◽  
Long Term Treatment ◽  
Cord Injury

✓ A total of 93 patients with intractable spasticity due to either spinal cord injury (59 cases), multiple sclerosis (31 cases), or other spinal pathology (three cases) were entered into a randomized double-blind placebocontrolled screening protocol of intrathecal baclofen test injections. Of the 88 patients who responded to an intrathecal bolus of 50, 75, or 100 µg of baclofen, 75 underwent implantation of a programmable pump system for chronic therapy. Patients were followed for 5 to 41 months after surgery (mean 19 months). No deaths or new permanent neurological deficits occurred as a result of surgery or chronic intrathecal baclofen administration. Rigidity was reduced from a mean preoperative Ashworth scale score of 3.9 to a mean postoperative score of 1.7. Muscle spasms were reduced from a mean preoperative score of 3.1 (on a fourpoint scale) to a mean postoperative score of 1.0. Although the dose of intrathecal baclofen required to control spasticity increased with time, drug tolerance was not a limiting factor in this study. Only one patient withdrew from the study because of a late surgical complication (pump pocket infection). Another patient received an intrathecal baclofen overdose because of a human error in programming the pump. The results of this study indicate that intrathecal baclofen infusion can be safe and effective for the long-term treatment of intractable spasticity in patients with spinal cord injury or multiple sclerosis.

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