Short-term Efficiency and Tolerance of Ketoprofen and Methylprednisolone in Acute Sciatica: A Randomized Trial

Pain Medicine ◽  
2018 ◽  
Vol 20 (7) ◽  
pp. 1294-1299
Author(s):  
Romain Gastaldi ◽  
Marjorie Durand ◽  
Matthieu Roustit ◽  
Myriam Zulian ◽  
Irène Monteiro ◽  
...  

Abstract Objective Although anti-inflammatory drugs are commonly used in acute discogenic sciatica, data regarding their efficacy are scarce and controversial. We compared the efficacy and safety of intravenous ketoprofen and methylprednisolone with placebo in sciatica. Design Multicenter, double-blinded randomized controlled trial. Subjects Patients with confirmed discogenic acute sciatica, without neurologic deficit, were randomized into three arms. Methods Besides standard-of-care analgesic therapy, they received intravenous injections of methylprednisolone (60 mg/d) or ketoprofen (200 mg/d) or placebo for five days. The primary outcome was leg pain over five days. Secondary outcomes were clinical responses at days 3 and 5, lumbar pain, Straight Leg Raise Test and lumbar flexion index, analgesic consumption, realization of lumbar spine injections, and surgery during the study period. Results Fifty-four patients were randomized, and 50 completed the study. In patients admitted to the hospital for pain control with acute lumbar radicular pain due to intervertebral disc herniation and receiving an oral analgesic protocol including paracetamol, nefopam, tramadol, and morphine, there was no additional analgesic effect seen between groups. There was no significant difference in leg pain between the three groups over the study period. In the methylprednisolone group, however, we observed a higher rate of clinically relevant responses at day 3. No difference was observed on other secondary efficacy outcomes and safety. Conclusion No significant difference in leg pain was observed between groups. However, there was a higher proportion of patients relieved with intravenous methylprednisolone at day 3, compared with ketoprofen or placebo.

2020 ◽  
Vol 45 (10) ◽  
pp. 767-773
Author(s):  
Zachary L. McCormick ◽  
Taylor Burnham ◽  
Shellie Cunningham ◽  
Richard W Kendall ◽  
David Bougie ◽  
...  

BackgroundLow-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.ObjectiveDetermine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.DesignDouble-blinded randomized control trial.MethodsPatients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in >1 myotome and ≥50% pain reduction on the numerical scale.Results120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).ConclusionLow-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.Trial registration detailsClinicalTrials.gov (NCT03127137); December 26, 2017.


2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A32-A32
Author(s):  
C Ellender ◽  
C Samaranayake ◽  
B Duce ◽  
M Boyde ◽  
S Winter ◽  
...  

Abstract OSA is a prevalent chronic disease with significant health implications, for which achieving >4 hours/night on continuous positive airway pressure (CPAP) is essential for effective treatment. Educational videos to improve CPAP adherence are of interest as a low-cost intervention, however trials have shown mixed results. This study aimed to compare CPAP usage following standard of care education (SOCE), with the usage following the addition of educational videos, customised to incorporate low health literacy communication, motivational and self-efficacy techniques. Methods Adults with OSA recommended treatment with CPAP, were recruited and randomised in a single blinded method, to watch short educational videos following their in laboratory CPAP study or SOCE. The primary outcome was CPAP usage at 2mths and secondary outcomes were usage at 12mth and proportion of patients with adequate usage >4hrs/night. Results 195 patients met the eligibility criteria and were randomised to video education (n = 96) or to SOCE (n = 99). There was no significant difference in compliance at 2mths (median usage 1.7hrs IQR 0–6.2 SOCE, 4.4hrs IQR 0–6.7 video education p = 0.1), however at 12mths there was increased usage in the video education arm (median 0hrs IQR 0–5.4 standard of care, 3.8hrs IQR 0–6.87 p = 0.05). The proportion with adequate CPAP usage >4hrs/night at 12mths was higher in the video education group (33, 33% versus 48, 50% p = 0.01). Conclusions Long-term adherence to CPAP is enhanced by the addition of educational videos that incorporate low health literacy communication and motivational techniques, compared to SOCE.


2016 ◽  
Vol 310 (10) ◽  
pp. F1016-F1025 ◽  
Author(s):  
Ann M. Lin ◽  
Peizhou Liao ◽  
Erin C. Millson ◽  
Arshed A. Quyyumi ◽  
Jeanie Park

Chronic kidney disease (CKD) patients have an exaggerated increase in blood pressure (BP) during rhythmic handgrip exercise (RHG 20%) and static handgrip exercise (SHG 30%). Nitric oxide levels increase during exercise and help prevent excessive hypertension by both increasing vasodilation and reducing sympathetic nerve activity (SNA). Therefore, we hypothesized that tetrahydrobiopterin (BH4), an essential cofactor for nitric oxide synthase, would ameliorate the exaggerated exercise pressor response in CKD patients. In a randomized, double-blinded, placebo-controlled trial, we tested the effects of 12 wk of sapropterin dihydrochloride (6 R-BH4; n = 18) versus placebo ( n = 14) treatement on BP and muscle SNA (MSNA) responses during RHG 20% and SHG 30% in CKD patients. The 6 R-BH4-treated group had a significantly lower systolic BP (+6 ± 1 vs. +13 ± 2 mmHg, P = 0.002) and mean arterial pressure response (+5 ± 1 vs. +10 ± 2 mmHg, P = 0.020) during RHG 20% and a significantly lower systolic BP response (+19 ± 3 vs. +28 ± 3 mmHg, P = 0.043) during SHG 30%. Under baseline conditions, there was no significant difference in MSNA responses between the groups; however, when the BP response during exercise was equalized between the groups using nitroprusside, the 6 R-BH4-treated group had a significantly lower MSNA response during RHG 20% (6R-BH4 vs. placebo, +12 ± 1 vs. +21 ± 2 bursts/min, P = 0.004) but not during SHG 30%. These findings suggest that 6 R-BH4 ameliorates the augmented BP response during RHG 20% and SHG 30% in CKD patients. A reduction in reflex activation of SNA may contribute to the decreased exercise pressor response during RHG 20% but not during SHG 30% in CKD patients.


2017 ◽  
Vol 51 (12) ◽  
pp. 1041-1052 ◽  
Author(s):  
Jian-Rong Guo ◽  
Xiao-Ju Jin ◽  
Hua-Chun Shen ◽  
Huan Wang ◽  
Xun Zhou ◽  
...  

Background: There remains a lack of a systematic summary of the efficacy and safety of various medicines for sciatica, and discrepancies among these exist. Objective: The aim of this study is to comprehensively assess the efficacy of and tolerance to several medical options for the treatment of sciatica. Methods: We performed a network meta-analysis and illustrated the results by the mean difference or odds ratio. The surface under the cumulative ranking curve (SUCRA) was used for indicating the preferable treatments. All data analyses and graphs were achieved via R 3.3.2 and Stata 13.0. Results: The subcutaneous anti–tumor necrosis factor–α (anti-TNF-α) was superior to the epidural steroid + anesthetic in reducing lumbar pain in both acute + chronic sciatica patients and acute sciatica patients. The epidural steroid demonstrated a better ability regarding the Oswestry disability score (ODI) compared to the subcutaneous anti-TNF-α. In addition, for total pain relief, the use of nonsteroidal antiinflammatory drugs was inferior to the epidural steroid + anesthetic. The epidural anesthetic and epidural steroid + anesthetic both demonstrated superiority over the epidural steroid and intramuscular steroid. The intravenous anti-TNF-α ranked first in leg pain relief, while the subcutaneous anti-TNF-α ranked first in lumbar pain relief, and the epidural steroid ranked first in the ODI on the basis of SUCRA. In addition, their safety outcome (withdrawal) rankings were all medium to high. Conclusions: Intravenous and subcutaneous anti-TNF-α were identified as the optimal treatments for both acute + chronic sciatica patients and acute sciatica patients. In addition, the epidural steroid was also recommended as a good intervention due to its superiority in reducing ODI.


2021 ◽  
Vol 29 (6) ◽  
pp. 312-315
Author(s):  
JOAO PAULO FERNANDES GUERREIRO ◽  
JOSE RODOLFO MARTINES BALBINO ◽  
BRUNO POSSANI RODRIGUES ◽  
MARCUS VINICIUS DANIELI ◽  
ALEXANDRE OLIVEIRA QUEIROZ ◽  
...  

ABSTRACT Objective: To examine and compare the clinical efficacy of intraarticular epsilon aminocaproic acid (EACA) and tranexamic acid (TXA) in total knee arthroplasty (TKA). Methods: This study was a prospective, single-center, double-blinded randomized controlled trial, including sixty patients with osteoarthritis of the knee divided into two groups of 30 patients. In the TXA group, 1 g of TXA (0.05 g/ml) was applied intraarticularly, and in the EACA group, 4 g of EACA (0.2 g/ml) was applied intraarticularly. Serum hemoglobin (Hgb) and hematocrit (Htb) were measured during the preoperatively and 24 and 48 hours postoperatively. The range of motion and pain were evaluated by clinical examination. To evaluate knee function before and 2 months after surgery, the Western Ontario and McMaster Universities Index (WOMAC) questionnaire was used. Results: In total, 56 (93.3%) patients were evaluated up to the second postoperative month. No significant difference between the groups (p > 0.05) was found in the decrease in Hgb or Htb at 24 or 48 hours. Regarding assessment of the pain, WOMAC score and gain in knee flexion, no significant advantages up to 60 days after surgery (p > 0.05) were found. Conclusions: The decrease in Hgb and Htb during the first 48 hours postoperatively and the risk of transfusion were similar with the intraarticular use of 1 g of TXA and 4 g of EACA in TKA. The possible benefits regarding knee pain, gain in flexion and function were also similar for the two drugs. Level of Evidence II, Randomized, Double-Blinded, Single-Centre, Prospective Clinical Trial.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Evan J Lytle ◽  
Chad F Claus ◽  
Doris Tong ◽  
Diana Sigler R.Ph ◽  
Dominick Lago ◽  
...  

Abstract INTRODUCTION Use of Ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. Recent literature suggested that such an effect could be type and dose-related. We sought to demonstrate that Ketorolac use was safe with significant opioid-sparing effect and non-inferior fusion rate. METHODS This is a prospective, double-blinded, randomized placebo-controlled trial designed according to the 2013 SPIRIT Guidelines. It is a 2-arm parallel design with a 1:1 randomization. Over a 2- period under 6 surgeons at 2 sites, consecutive patients who underwent elective 1 to 3 level minimally invasive thoracolumbar fusion were screened for inclusion/exclusion. Patients with fusion confounders were excluded. A centralized treatment allocation mechanism and Excel-generated block randomization were used. Patients received a 48-hr scheduled treatment of intravenous Ketorolac (15 mg IV Q6H) or saline. We implemented a standardized analgesia regimen using a standardized order set. The primary outcome was fusion as evaluated XR/CT using the Suk criteria at 6/12 mo by a blinded neuroradiologist. The secondary outcomes were morphine-equivalence (MME) in the first 48 hr postop and during the hospital stay, NSAIDs-specific perioperative complications, VAS, length of stay, and quality-of-life outcomes at 6/12 mo. Univariate analysis was used, P < .05 considered significant. The sample size was estimated to be 600. This is an interim analysis to evaluate the safety and MME reduction. RESULTS A total of 142 patients were analyzed. Patient characteristics and operative data were comparable between the groups except EBL. No significant difference in fusion was found at 6-mo. There was a significant reduction in total/48-hr MME and length of stay (LOS) for the ketorolac group. The only complication was a superficial hematoma in a ketorolac-assigned patient requiring evacuation. CONCLUSION Ketorolac demonstrated safety, a significant reduction in postoperative opioid use and length of stay when used as part of a multi-modal analgesic regimen after thoracolumbar fusion.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6610-6610
Author(s):  
Tina Hsu ◽  
Carol Stober ◽  
Dean Fergusson ◽  
Kelly Daigle ◽  
Noorza Moledina ◽  
...  

6610 Background: Prior to receiving docetaxel-based chemotherapy patients often incorrectly take all or part of their steroid-premedication. The lack of standardised steroid-replacement strategies can lead to variability in care and delays in starting chemotherapy while nursing/pharmacy/physicians establish an individualized patient plan, which can use up valuable chemotherapy chair time. A randomised controlled trial comparing a fixed-oral dose of dexamethasone and physician-directed replacement was performed. Methods: Patients who missed at least one dose of steroid-premedication were randomised to either standard replacement with dexamethasone 8mg orally or physician-directed replacement (any steroid, dose or route). The primary outcome was time from randomisation to starting docetaxel. Secondary outcomes included rates of acute and delayed hypersensitivity reactions, fluid retention and skin rashes. Results: Sixty patients were randomized. Most patients were enrolled during cycle 1 (47.5%) and cycle 2 (22%) of docetaxel. The most frequent total doses of dexamethasone omitted were 24 mg (27%), 12 mg (20%), and 8 mg (19%). There were 7 different replacement strategies used by physicians. The most frequently used strategies were: dexamethasone 8mg IV (34.5%), 12mg IV (17.2%) and 20mg IV (13.8%). Patients in the fixed-dose arm received docetaxel earlier than patients in the physician-choice arm, at a median of 47.5 and 61 minutes after randomization (mean = 62.2 vs 83.4 minutes) (p = 0.033). No significant difference in rates of acute (0 vs 2)/delayed allergic reactions (1 vs 0), fluid retention (2 vs 1), or skin rashes (1 vs 0) was observed between the fixed-dose and physician-choice arms respectively. Conclusions: This is the first randomised trial to compare steroid-replacement strategies in this patient population. Fixed-dose replacement with dexamethasone 8 mg PO should be the preferred standard of care, as it reduces both the time to starting docetaxel and treatment variability, with no apparent increase in toxicity. Clinical trial information: NCT02815319.


2018 ◽  
Vol 8 (1) ◽  
pp. 44-49
Author(s):  
Hamid-Reza Omrani ◽  
Sima Golmohhamadi ◽  
Amir-Hossein Hashemian ◽  
Ali-Zaman Vaysmoradi ◽  
Roya Safari-Faramani

Introduction: Anemia, as a common complication of end-stage renal disease (ESRD), usually develops due to erythropoietin deficiency. Recombinant human erythropoietins (rHEPOs) are indicated for the correction of renal anemia. Objectives: We aimed to evaluate the efficacy of a new brand of erythropoietin named CinnaPoietin (erythropoietin beta) on hemoglobin levels. Patients and Methods: This is a randomized double-blinded controlled trial. Ninety-six ESRD patients on hemodialysis recruited in the study, whose hemoglobin levels was less than 10 g/dL. They allocated to two groups. PDPoetin (erythropoietin alfa) 50-100 U/kg three times per week intravenously administrated to the control group and CinnaPoietin with exactly same regimen as like PDPoetin group administrated for the rest of the participants. The study duration was 3 months. We measured plasma hemoglobin monthly for 3 months. Results: We found, hemoglobin was increased across the time and it was statistically significant (P<0.001), while there was no statistically significant differences between the groups (P=0.712). Conclusion: According to the result of the present study there is no statistical significant difference between these two brands of exogenous rHEPO in the case of increasing the hemoglobin concentration.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259699
Author(s):  
Stefanie Vandervelden ◽  
Lina Wauters ◽  
Jan Breuls ◽  
Steffen Fieuws ◽  
Philippe Vanhove ◽  
...  

Background Sepsis is a potentially life-threatening condition characterized by a deregulated body’s response to infection causing injury to its own tissues and organs. Sepsis is the primary cause of death from infection. If not recognized and treated timely, it can evolve within minutes/hours to septic shock. Sepsis is associated with an acute deficiency of Vitamin C. Despite the proof-of-concept of the benefit of administering Vitamin C in patients with sepsis or septic shock, Vitamin C administration is not yet current practice. Objective To investigate the potential benefit of early administration of high doses of Vitamin C in addition to standard of care in patients with sepsis or septic shock. Methods This phase 3b multi-center trial is conducted in 8 hospitals throughout Belgium. In total 300 patients will be randomly assigned to one of two groups in a 1:1 allocation ratio. The intervention group will receive 1.5 g Vitamin C 4 times a day during 4 days, started within 6 hours after admission. The primary outcome is the average post-baseline patient SOFA score. Conclusion This trial will determine whether the early administration of Vitamin C in patients with sepsis or septic shock can lead to a more rapid solution of shock and less deterioration from sepsis to septic shock, hereby reducing morbidity and mortality as well as the length of hospital stay in this patient population. Trial registration The C-EASIE trial has been registered on the ClinicalTrials.gov website on 10 February 2021 with registration number NCT04747795. Trial Sponsor UZ Leuven (sponsor’s reference S63213)


2021 ◽  
Author(s):  
Nien-Ying Tsai ◽  
Shu-Wen Jao ◽  
Chao-Yang Chen ◽  
Chia-Cheng Wen ◽  
Chien-Chang Kao ◽  
...  

Abstract Background: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain.Patients And Methods: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.Results: Fifty patients were studied in two groups. The surgical outcomes of the two groups were no different. The median subjective pain scores at 0, 8, 16, 24 h after the operation showed no significant difference between the two groups (p = 0.55 at 0 h; p = 0.38 at 8 h; p = 0.98 at 16 h; and p = 0.66 at 24 h). The mean times to first urination after the operation were 700.04 ± 455.03 min in the non-fluid-restriction group and 737.16 ± 426.32 min in the fluid-restriction group (no significant difference; p = 0.67). No postoperative urinary retention was found in either group of patients.Conclusions: Fluid restriction after stapled hemorrhoidopexy is unnecessary.Trial registration: This study was reviewed and approved by the Tri-Service General Hospital Institutional Review Board for human subjects (No. 2-106-05-063). This study also had trial registration with clinicalTrials.gov (Identifier: NCT04459039).


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