Safety and Efficacy of Two Potassium Cocktail Formulations for Treatment of Neonatal Hyperkalemia

2011 ◽  
Vol 45 (11) ◽  
pp. 1371-1377
Author(s):  
Alexandra Oschman ◽  
Amanda Gansen ◽  
Howard Kilbride ◽  
Tracy Sandritter
Keyword(s):  
Serum Potassium ◽  
Linear Models ◽  
Mixed Linear Models ◽  
Improvement Project ◽  
Safety And Efficacy ◽  
Treatment Regimens ◽  
Group 2 ◽  
Record Review ◽  
Blood Glucose Concentrations ◽  
Group 1

Background:: A consensus has not been established for the standard treatment of hyperkalemia in the neonatal population. Most treatment regimens include a dextrose/insulin infusion. Additional agents used include calcium, sodium bicarbonate, polystyrene sulfonate, and albuterol. This study assessed the safety and efficacy of a potassium cocktail (k-cocktail) containing dextrose, insulin, calcium gluconate, and sodium lactate for treatment of neonatal hyperkalemia. Objective: To determine whether modifications to a potassium cocktail formulation, based on a prior quality improvement project, resulted in a decrease in the incidence of hyperglycemia and acidosis associated with its use, and to evaluate the effectiveness of the k-cocktail in lowering serum potassium levels and the incidence of adverse effects. Methods: We conducted a retrospective cohort study of neonates with hyperkalemia who received 2 k-cocktail formulations (group 1 [n = 13], original formulation, dextrose:insulin 5:1; group 2 [n = 26], modified formulation, dextrose: insulin 3.3:1). Group 2 subjects were matched 2:1 by gestational age and birth weight with those in group 1. Variables related to safety and effectiveness of therapy were assessed by medical record review. The following tests were used to assess group differences: χ2, Fisher exact, 2-tailed t-tests, and mixed linear models. Results: The incidence of hyperglycemia during the modified k-cocktail infusion in group 2 decreased from 76.9% to 217% (p = 0.001). Serum blood glucose concentrations increased during the infusion, on average, for group 1 infants and were unchanged during the infusion for those in group 2. The incidence of acidosis during the infusion was similar between groups (group 1 [76.9%] vs group 2 [68.2%]; p = 0.58). No significant adverse events were observed. Serum potassium concentrations decreased similarly in both groups. Conclusions: An intravenous infusion including a dextrose:insulin ratio of 3.3:1. compared with a higher ratio, results in less hyperglycemia and appears to be as effective in decreasing potassium concentrations in newborns.

scholarly journals Longitudinal Phenotypes Improve Genotype Association for Hyperketonemia in Dairy Cattle

Animals ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. 1059 ◽  
Author(s):  
Francisco A. Leal Yepes ◽  
Daryl V. Nydam ◽  
Sabine Mann ◽  
Luciano Caixeta ◽  
Jessica A. A. McArt ◽  
...  
Keyword(s):  
Linear Models ◽  
Association Studies ◽  
Genetic Selection ◽  
Area Under The Curve ◽  
Genome Wide Association Studies ◽  
Nucleotide Polymorphisms ◽  
Mixed Linear Models ◽  
Biological Insight ◽  
Group 2 ◽  
Genomic Regions

The objective of our study was to identify genomic regions associated with varying concentrations of non-esterified fatty acid (NEFA), β-hydroxybutyrate (BHB), and the development of hyperketonemia (HYK) in longitudinally sampled Holstein dairy cows. Our study population consisted of 147 multiparous cows intensively characterized by serial NEFA and BHB concentrations. To identify individuals with contrasting combinations in longitudinal BHB and NEFA concentrations, phenotypes were established using incremental area under the curve (AUC) and categorized as follows: Group (1) high NEFA and high BHB, group (2) low NEFA and high BHB), group (3) low NEFA and low BHB, and group (4) high NEFA and low BHB. Cows were genotyped on the Illumina Bovine High-density (777 K) beadchip. Genome-wide association studies using mixed linear models with the least-related animals were performed to establish a genetic association with HYK, BHB-AUC, NEFA-AUC, and the comparisons of the 4 AUC phenotypic groups using Golden Helix software. Nine single-nucleotide polymorphisms were associated with high longitudinal concentrations of BHB and further investigated. Five candidate genes related to energy metabolism and homeostasis were identified. These results provide biological insight and help identify susceptible animals thus improving genetic selection criteria thereby decreasing the incidence of HYK.

scholarly journals Preliminary Safety and Efficacy Results with an Intermittent Schedule of the PI3kδ Inhibitor ME-401 Alone or in Combination with Rituximab for B-Cell Malignancies

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2893-2893 ◽  
Author(s):  
Andrew D. Zelenetz ◽  
Jacob D. Soumerai ◽  
Deepa Jagadeesh ◽  
Nishitha Reddy ◽  
Anastasios Stathis ◽  
...  
Keyword(s):  
B Cell ◽  
Research Funding ◽  
Objective Response ◽  
Intermittent Schedule ◽  
Safety And Efficacy ◽  
Group 2 ◽  
Grade 3 ◽  
Expansion Cohort ◽  
Group 1

Abstract Background: ME-401, a potent and selective oral PI3kδ inhibitor, achieved a high rate of early and durable responses in patients with follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) when administered once daily in 28-day cycles on a continuous schedule (CS) in a dose escalation Phase 1b study (Soumerai et al, ASCO 2018:#7519). The most common adverse events (AEs) were the delayed onset (beyond Cycle 2) of grade 3 diarrhea and rash, which were reversible with drug interruption and/or corticosteroids. These delayed AEs were thought to be due to pathway inhibition in regulatory T cells (Treg) leading to a disruption in immune homeostasis. We hypothesized that an intermittent schedule (IS) beyond Cycle 2 might mitigate or reduce the incidence of significant delayed AEs. The IS tested was selected based on the kinetics of Treg repopulation, and consists of ME-401 administered on days 1-7 of a 28-day cycle. We report preliminary results of this strategy. Methods: Group 1 included 31 patients with relapsed FL (n = 22) or CLL/SLL (n = 9) who received ME-401 on a CS at doses ≥60 mg per day. 11/29 patients (38%) who received >2 cycles of therapy had developed delayed grade 3 AEs on CS and could be re-challenged with either the CS or IS (from December 2017 onward) following recovery from toxicity. The other 18/29 patients (62%) had not developed a grade 3 AEs of interest on CS and, beginning in December 2017, were switched to IS after a median of 26 weeks (range, 8-49) of daily dosing. Group 2 included 15 patients with relapsed FL (n = 9), diffuse large B-cell lymphoma (n = 4), marginal zone lymphoma (MZL, n = 1), and CLL (n = 1) who received rituximab 375 mg/m2 x 8 doses over 6 months and ME-401 at 60 mg daily x 2 cycles then switched to the IS. Group 3 includes 30 patients with relapsed FL/CLL/SLL enrolling in an expansion cohort of ME-401 alone at 60 mg daily x 2 cycles then switching to IS. Results: Group 1: Of the 11 patients who developed a delayed grade 3 AE on CS, 6 were never re-challenged, 2 were re-challenged with CS with recurrence of their AE, and 3 were re-challenged with IS without recurrence of their AE. Of the 18 patients switched to the IS, and with a median follow-up of 5.2 months (range, 2.3-6.6) on IS, 3 developed grade 3 diarrhea on IS, 2 in the first cycle and 1 in the second cycle after the switch to IS, of whom 2 have been re-treated with IS for 1+ and 5+ months without recurrence of the AE. One patient was not evaluable for response due to discontinuation on Day 28 for personal reasons and 27/30 (90%) evaluable patients achieved an objective response. With a median follow-up of 9.4 months (range, 2.2-17.5) from enrollment, only 2/27 (7%) responders had disease progression (PD) on CS and were discontinued. Of the 18 patients who were switched to IS, only 1 SLL patient with a partial response (PR) achieved on CS developed PD on IS and was successfully rescued with switch back to CS. Another CLL patient in PR on CS had 10% increase in SPD from nadir in Cycle 5 on the IS and was switched back to CS. Group 2: 10/15 patients have completed 2 cycles of daily dosing at the time of analysis and were systematically switched to IS. With a median follow-up of 3.4 months (range, 1.5-5.7) on IS, only 1/10 patients developed delayed grade 3 diarrhea in the first cycle after switch to IS. 7/10 patients (70%) with FL/MZL achieved an objective response and no PD was reported with a median follow-up of 5.2 months (range, 3.1-7.5) from enrollment. Conclusions: Preliminary data suggest that switching to an intermittent schedule consisting of ME-401 administered on days 1-7 of a 28-day cycle following 2 cycles of continuous daily dosing was associated with a low rate of delayed grade 3 AEs and was associated with preservation of response in the vast majority of patients. All delayed grade 3 AEs of interest on IS occurred within 1-2 cycles of switching from CS to IS, suggesting that these might have represented a delayed effect of daily dosing. IS may also be a suitable re-treatment strategy in patients with delayed AEs on CS. Safety and efficacy data for the expansion cohort of 30 patients treated with ME-401 at 60 mg for 2 cycles then switched to IS will be presented at the meeting. A randomized study comparing CS and IS in FL is planned. Disclosures Zelenetz: Abbvie: Research Funding; Celgene: Consultancy; AstraZeneca: Consultancy; Novartis/Sandoz: Consultancy; Amgen: Consultancy; Gilead: Consultancy, Research Funding; Genentech/Roche: Consultancy, Research Funding. Reddy:MEI Pharma: Research Funding. Stathis:Oncology Therapeutic Development: Research Funding. Ghalie:MEI Pharma: Employment, Equity Ownership; Viracta Therapeutics: Membership on an entity's Board of Directors or advisory committees. Pagel:Pharmacyclics, an AbbVie Company: Consultancy; Gilead: Consultancy.

scholarly journals Optimization of systemic juvenile arthritis treatment regimens with correction of tocilizumab intravenous administration according to data of observational retrospective study

2019 ◽  
Vol 57 (2) ◽  
pp. 229-234
Author(s):  
M. I. Kaleda ◽  
I. P. Nikishina ◽  
O. M. Kostareva
Keyword(s):  
Retrospective Study ◽  
Age Of Onset ◽  
Ferritin Level ◽  
Juvenile Arthritis ◽  
Active Growth ◽  
Initial Interval ◽  
Treatment Regimens ◽  
Reactive Protein ◽  
Group 2 ◽  
Group 1

Objective: to assess the possibility of using varying interval between intravenous infusions of tocilizumab (TCZ) as a tool for choosing the optimal treatment regimen in systemic juvenile arthritis (SJA).Subjects and methods. The observational retrospective study included 72 patients (29 boys and 43 girls) with a SJA fulfilled ILAR criteria, who received TCZ ≥12 months, in which previous therapy with various anti-rheumatic drugs was ineffective. We studied the changes of the main clinical and laboratory parameters of the SJA activity after correction of the interval between infusions.Results and discussion. In the studied group median age of onset was 3.8 [2.1; 5.9] years, duration of disease before the appointment of TCZ – 26.5 [9.25; 62.25] months. Therapy is continued by 70 patients, the median duration of therapy is 5.0 [2.75; 6.38] years. The initial interval between TCZ infusions was 2 weeks in 49 (group 1) and 4 weeks in 23 patients (group 2). After 6 months of therapy in group 2, the interval was reduced to 2 weeks in 15 (65.2%) patients due to decreased effectiveness. Prolongation of the period between the introduction of TCZ in patients of group 1 who did not reach the inactive status of the disease in the 1st year of the disease resulted in a significant increase of erythrocyte sedimentation rate, C-reactive protein level and exacerbation of systemic manifestations of SJA (p<0.01) in the absence of statistically significant changes of joint status parameters (p>0.05). 40% of these patients had involvement of «new» joints, including hip joints. «Harbingers» of exacerbation in the period of increasing intervals between infusions were: arthralgia (88%), myalgia (65%), sore throat (30%), dysphoria (50%, more often in preschool children), increase of ferritin level and number of leukocytes. In 90.3% of patients who have reached the inactive status of the disease, it was possible to gradually increase the interval between infusions. In 6 patients, TCZ was canceled by gradually increasing the intervals, in 4 of them, therapy was resumed at an initial interval of 2 weeks after 3, 6, 21 and 22 months, respectively, in two patients, a drug-free remission was maintained during 23 and 20 months. Reduction of intervals to the initial 2 weeks was performed in 13 (18.1%) patients. The development of exacerbations with the need to reduce the interval to the initial one was most often observed at 24–35 months of therapy, which chronologically coincided with the period of active growth. Currently, 15 patients receiving TCZ with an interval of 5–6 weeks, and 40 – with an interval of 4 weeks, 9 patients – 3 weeks, in 6 patients attempt to increase the interval to more than 2–2,5 weeks was unsuccessful.Conclusion. Experience suggests the need to comply with a two-week interval between infusions of TCZ at the initial stage of therapy in most patients with SJA until the inactive stage of the disease, followed by a smooth individual increase in the interval to 4 weeks (2–3 days under careful medical supervision). Appearance of initial signs of exacerbation, requires to reduce the interval to 2 weeks. Before deciding on the complete withdrawal of TCZ, it is advisable to increase the interval between infusions to 5–6 weeks under careful clinical and laboratory control.

scholarly journals COVID-19 and antibacterial therapy in the inpatient settings: to whom, when, why?

2021 ◽  
Vol 31 (6) ◽  
pp. 701-709
Author(s):  
Nina A. Karoli ◽  
Alena V. Aparkina ◽  
Elena V. Grigoryeva ◽  
Nadezhda A. Magdeeva ◽  
Natalia M. Nikitina ◽  
...  
Keyword(s):  
Bacterial Infection ◽  
Elective Surgery ◽  
Unintended Consequences ◽  
Hospitalized Patients ◽  
Fourth Generation ◽  
Treatment Regimens ◽  
Inpatient Settings ◽  
Group 2 ◽  
To Receive ◽  
Group 1

Although antibiotics (ABs) are ineffective against COVID-19, they are often prescribed to patients with the new coronavirus infection. Many of these prescriptions are uncalled for.The aim of the work is to assess the frequency of prescribing antibiotics to hospitalized patients with confirmed COVID-19, identify the most commonly prescribed ABs, and determine the significance of various biomarkers for the diagnosis of bacterial infection.Methods. A retrospective analysis of 190 inpatient cases with confirmed COVID-19 was carried out. The records of COVID-19 patients who were admitted to the intensive care unit were excluded from the analysis. Two groups were formed: 30 patients (group 1) with COVID-19, emergency or elective surgery, and exacerbation of chronic infectious diseases, and 160 patients (group 2) with manifestations of COVID-19 only.Results. ABs were prescribed to 189 patients upon admission to the hospital. The most frequently prescribed ABs included macrolides (63.5%), respiratory fluoroquinolones (49.7%), and third or fourth-generation cephalosporins (57.1%). ABs were administered starting from the first day of admission and until the discharge. The patients in group 2 were more often prescribed respiratory fluoroquinolones and, less often, III - IV generation cephalosporins. Moreover, macrolides were used in the treatment regimens of both groups. Longer administration of respiratory fluoroquinolones to patients in group 2 than patients in group 1 (p < 0,05) was noted. Group 2 also tended to receive longer therapy with macrolides. On admission, the patients with signs of bacterial infection had more significant leukocytosis with a neutrophilic shift, a more common increase in ESR of more than 20 mm/h and an increase in the level of procalcitonin > 0,5 ng/ml.Conclusion. ABs were administered to the overwhelming majority of hospitalized patients in the absence of clear therapeutic indications. The ABs are likely to have a minimal benefit as empirical treatment of COVID-19 and are associated with unintended consequences, including adverse effects and increased antibiotic resistance. According to our data, the most informative markers of a secondary bacterial infection in patients with COVID-19 are leukocytosis with a neutrophilic shift, an increase in ESR of more than 20 mm/h, and a procalcitonin level of more than 0,5 ng/ml.

One-stage nasal and multi-level pharyngeal surgery for obstructive sleep apnoea: safety and efficacy

2005 ◽  
Vol 119 (4) ◽  
pp. 272-276 ◽  
Author(s):  
Kenny P Pang
Keyword(s):  
Sleep Apnoea ◽  
Upper Respiratory Tract ◽  
Safety And Efficacy ◽  
Surgical Success ◽  
One Stage ◽  
Obstructive Sleep ◽  
Upper Respiratory ◽  
Multi Level ◽  
Group 2 ◽  
Group 1

A collapsible airway is often the common denominator in sleep-disordered breathing (SDB). The upper respiratory tract includes the nasal passage, nasopharynx, oral cavity, oropharynx, base-of-tongue region and the hypopharynx. It is believed that the highest amount of resistance in the upper respiratory tract is in the nasal cavities, and particularly the nasal valve. Most authors believe that when considering surgical options for patients with obstructive sleep apnoea (OSA) it is imperative to correct nasal pathology together with the other sites of airway obstruction. In this retrospective study, I sought to investigate the safety and efficacy of one-stage nasal and multi-level pharyngeal surgery. I compared two groups of patients: group 1, receiving one-stage nasal and multi-level pharyngeal surgery; and group 2, receiving only multi-level pharyngeal surgery. In group 1, nine out of 12 patients (75 per cent) met the criteria for surgical success, with a mean pre-operative apnoea-hypopnoea index (AHI) decreasing from 36.3 to 8.9 post-operatively (p<0.0002), while in group 2, 25 out of 40 patients met the surgical success criteria (62.5 per cent), with their mean AHI decreasing from 52.6 to 10.2 (p<0.0000). When comparing the surgical success rates between the two groups, it was not statistically significant, at p>0.106. There were no postoperative respiratory-related complications despite having bilateral nasal Merocel (tampon) packing in place (in group 1), and none of the patients in either group had any desaturation, hypoxaemia, apnoea or OSA-related complications. This series suggests that, with adequate post-operative monitoring, it is both safe and efficacious to perform both nasal and multi-level pharyngeal surgery in the one surgical session.

Safety and efficacy of stenting nonthrombotic iliac vein lesions in octogenarians and nonagenarians in an office setting

Vascular ◽  
2017 ◽  
Vol 26 (1) ◽  
pp. 70-74 ◽  
Author(s):  
Pavel Kibrik ◽  
Justin Eisenberg ◽  
Ahmad Alsheekh ◽  
Syed Ali Rizvi ◽  
Afsha Aurshina ◽  
...  
Keyword(s):  
Intravascular Ultrasound ◽  
Stent Placement ◽  
Venous Insufficiency ◽  
Iliac Vein ◽  
Safety And Efficacy ◽  
Office Setting ◽  
Venous Stenting ◽  
Area Of Interest ◽  
Group 2 ◽  
Group 1

Objectives Treatment options for venous insufficiency are rapidly evolving in the office setting and include venography, intravascular ultrasound, and venous stenting. Non-thrombotic iliac vein lesions assessment and treatment in an office setting is currently an area of interest. The purpose of this study is to demonstrate the safety and efficacy of evaluating non-thrombotic iliac vein lesion with this office-based procedure in octogenarians and nonagenarians. Methods From January 2012 through December 2013, 300 non-thrombotic iliac vein lesion limbs in 192 patients with venous insufficiency ≥80 years old were evaluated for non-thrombotic iliac vein lesion. Patients were evaluated and treated with venography, intravascular ultrasound, and stent placement for significant lesions demonstrated by greater than 50% diameter or cross-sectional area reduction. Group 1: 168 of these patients were octogenarians; female/male ratio was 1.75:1, bilateral in 89/168 patients (53%), left sided in 131/259 limbs (51%), right sided in 128 limbs (49%), average age 83.5 ± 2.6 years (range 80–89) compared to Group 2: 24 nonagenarians; female/male was 3:1, bilateral in 17/24 patients (70%), left sided in 20/41 limbs (49%), right sided in 21/41 limbs (51%), average age 92.9 ± 2.2 years (range 90–99). Stent related outcomes were evaluated with communication to the patient within 24 h to assess post-procedure pain followed by serial iliocaval ultrasonography. Results Out of the 300 limbs evaluated, in Group 1, 86% of limbs had stents placed compared to 90% in Group 2 and 11% of both groups had two stents placed. Overall improvement in pain, edema, and ulcers was reported in 147 (59%) of octogenarians and 24 (65%) of nonagenarians. There were no surgical site infections, pseudo-aneurysms, arteriovenous fistulas, or femoral artery injuries. No patients required transfusion within three days post-operatively and there were no 30-day mortalities in both sets of patients. Conclusions Our results demonstrate that there is no statistical difference in the outcome of performing venography, intravascular ultrasound, and stent placement in an office-based setting in octogenarians and nonagenarians. Both groups maintained a similar safety profile with low morbidity and mortality. In conclusion, we believe that the treatment of non-thrombotic iliac vein lesion in an office-based setting is safe and efficacious in both groups.

scholarly journals Clinical Safety and Efficacy of Ablation for Atrial Fibrillation Patients With a History of Stroke

2021 ◽  
Vol 8 ◽  
Author(s):  
Zi-liang Song ◽  
Shao-hui Wu ◽  
Dao-liang Zhang ◽  
Wei-feng Jiang ◽  
Mu Qin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Safety ◽  
Safety And Efficacy ◽  
Linear Lesions ◽  
Significant Difference ◽  
Stroke Group ◽  
History Of ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objectives: To evaluate the clinical safety and efficacy of radiofrequency catheter ablation for atrial fibrillation patients with a history of stroke.Methods and Results: A total of 116 symptomatic, drug-refractory AF patients with a history of stroke, and 1:2 matched patients without a history of stroke were enrolled. Of these, 28 cases occurred stroke within 3 months (Group 1), 88 cases with stroke history longer than 3 months (Group 2), and 232 cases without stroke (Group 3). PVI was performed in all patients, extended to ablation of linear lesions ablation. The periprocedural stroke rates and other procedure-related in-hospital complications did not differ significantly among the three groups. The maintenance rate of SR after the procedure showed no significant difference (p = 0.333), 52.7, 66.4, and 70.7% in Group 1, 2, and 3, respectively. Furthermore, the comparison between a history of stroke and those without it were also shown no significant difference (p = 0.351).Conclusions: Radiofrequency ablation for AF patients occurred stroke, even within 3 months is safe and effective, without higher periprocedural complication rate and recurrence rate.

scholarly journals A Comparative Study of Safety and Efficacy of Oral Terbinafine and Itraconazole in Patients of Tinea Corporis/ Tinea Cruris Infection, A Randomized Open Label Parallel Group Study

2021 ◽  
Vol 14 (3) ◽  
pp. 1543-1549
Author(s):  
S. Brigida ◽  
Arul Amutha Elizabeth ◽  
G. Soujania ◽  
R. Poornima Poornima
Keyword(s):  
Public Health Problem ◽  
Tinea Corporis ◽  
Open Label ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Tinea Cruris ◽  
Oral Itraconazole ◽  
Group 2 ◽  
Oral Terbinafine ◽  
Group 1

Introduction: Superficial dermatophytosis is a common public health problem in India, due to its tropical climate with heat and humidity. Today, the triazoles, mainly Itraconazole and the allylamines, chiefly Terbinafine, are the main ammunitions against dermatophytes. This study is undertaken to compare the safety and efficacy of both the drugs. Materials and Methods: This study was conducted to find the efficacy of Oral Terbinafine and Oral Itraconazole in Tinea Corporis/Tinea Cruris infection. The primary efficacy parameter was change in composite score (pruritus, erythema, pigmentations) from baseline to end of the treatment period. And to compare the safety of Oral Terbinafine and Oral Itraconazole by comparing the following parameters, Liver enzymes - SGOT/SGPT before and after treatment with the study drugs. Drug Dosage: Group 1: Drug –Tab. Terbinafine: Dose 500 mg per day once daily at bedtime for 2 weeks. Group 2: Drug –Tab. Itraconazole: Dose 200 mg per day, once daily at bedtime for 2 weeks. Results: The study participants show significant reduction in itching at the second follow up (after 2 weeks of drug completion) in both groups. Pruritis was reduced in 92% subjects in group 1 and 97.5% subjects in group 2. There was 87% reduction in erythema in group 1 and 93% reduction in group 2. Pigmentations were seen in 2% subjects in both groups indicating relapse of infection. Conclusion: The significant outcome of the study was that oral Itraconazole 200mg/day for 14 days(2 weeks) can be the better antifungal.

scholarly journals A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty

2016 ◽  
Vol 6;19 (6;7) ◽  
pp. 349-356 ◽  
Author(s):  
Anita Gupta
Keyword(s):  
Adverse Events ◽  
Surgical Procedures ◽  
Hip Arthroplasty ◽  
Orthopedic Surgery ◽  
Single Center ◽  
Safety And Efficacy ◽  
Pain Scores ◽  
Post Operative Pain ◽  
Group 2 ◽  
Group 1

Background: All surgical procedures are associated with a degree of pain. The experience of uncontrolled post-operative pain can have significant implications on health care costs. Recent studies have demonstrated that intravenous (IV) ibuprofen is an effective, safe, well-tolerated analgesic when administered for both abdominal hysterectomy and orthopedic surgery. The use of ibuprofen leads to a reduction in pain severity at rest and with movement and also decreases narcotic consumption. IV acetaminophen has also been shown to be effective in alleviating pain for surgical procedures. Given the established safety and efficacy of IV ibuprofen and IV acetaminophen for perioperative pain, we were interested in determining if any potential synergies are afforded by the simultaneous administration of both medications in orthopedic surgery patients. Objectives: Compare the safety and efficacy of the perioperative administration of IV ibuprofen alone and in combination with IV acetaminophen in total knee or hip arthroplasty. Study Design: Randomized, single center, trial. Setting: Tertiary care center in Philadelphia, Pennsylvania, United States. Methods: Seventy-eight patients undergoing elective knee or hip arthroplasty were randomized into 2 groups. Group 1 received 800 mg of IV ibuprofen at induction, and 800 mg of IV ibuprofen every 6 hours until discharge or for up to 5 days. Group 2 received 800 mg IV ibuprofen at induction and 1000 mg IV acetaminophen at closure, and 800 mg IV ibuprofen plus 1000 mg IV acetaminophen every 6 hours until discharge for up to 5 days. The primary endpoint was demonstrated using the visual analog scale (VAS) pain scores. Secondary endpoints included opioid requirements, quality of recovery scale (QoR), length of post-anesthesia care unit (PACU) stay, antiemetic consumption, opioid consumption, and opioid related adverse events. Results: Patients in Group 2 had lower VAS scores (P < 0.002) by day 3 only. Opioid requirements and adverse events were significantly less in Group 2 which was also statistically significant. Time to discharge from the PACU for Group 1 on average was 55 minutes and 38 minutes for Group 2 (P = 0.178) which was not statistically significant although may have clinical significance. Length of hospital stay was also evaluated; however, no statistical significance was noted between the 2 groups (P = 0.138). There was no significant difference in QoR scores which were 177 (SD = 15.44) for Group 1 (n = 35) and 179.5 (SD = 16.30) for Group 2 (n = 39). Limitations: The study is a single center study with the attendant risk of convenience bias. The total number of patients is also small and may call into question the reproducibility of the results. No cost analysis was undertaken as part of this study. Further research should aim at prospectively designed multi-center double blinded randomized control trials with an analysis of the pharmacoeconomics of the use of these agents. Conclusion: IV ibuprofen combined with IV acetaminophen demonstrated additional benefit in terms of improved pain scores on post-operative day 3 only, fewer potential adverse events related to opioid use, and decreased use of opioids when compared to IV ibuprofen alone. Key Words: Acute pain, post-operative pain, randomized controlled trial, surgery, NSAID, analgesia, acetaminophen

Abstract 1122‐000049: Safety and Efficacy of Daily Intra‐Arterial Endovascular Therapy for Refractory Cerebral Vasospasm Following Subarachnoid Hemorrhage

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Rahul Chandra
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Delayed Cerebral Ischemia ◽  
Safety And Efficacy ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Group 2 ◽  
Favorable Clinical Outcome ◽  
Vessel Dissection ◽  
Group 1

Introduction : Delayed cerebral ischemia (DCI) and cerebral infarction (CI) due to vasospasm is a major cause of death and disability after aneurysmal subarachnoid hemorrhage (aSAH). Transluminal balloon angioplasty (BA) and super‐selective intra‐arterial (IA) infusion of vasodilators are considered for refractory vasospasm. We examined the safety and efficacy of repeated daily IA treatment in vasospasm. Methods : We reviewed records a single center of vasospasm treatment for aSAH from 2016 through 2019. Primary endpoints were rate of cerebral infarctions and safety related to daily treatments. Secondary endpoints were mortality and favorable clinical outcome at hospital discharge defined as modified Rankin scale of scores 0–2. Results : Of 426 patients with SAH, 197 were aneurysmal with 79 with DCI. Forty‐five out of 79 underwent IA treatment, of which 14 underwent 1 or 2 treatments (Group 1) and 31 underwent ≥3 treatments (Group2). Incidence of CI were similar (Group 1: 42.8%; Group 2: 54.8%, p = 0.45) Good clinical outcomes at discharge were seen in 36% in Group 1 and 16% in Group 2 (p = 0.15). Mortality was 7% in group 1 and 26% in group 2 (p = 0.17). Conclusions : Complications including vessel dissection, systemic hypotension and seizures did not increase with repeated treatments. CI was not noted to differ, but the outcomes were worse in group 2 which may relate to severity of SAH rather than DCI.

Sign in / Sign up

Export Citation Format

Share Document