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

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

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Evelina Pantzar-Castilla ◽  
Brian Po-Jung Chen ◽  
Freeman Miller ◽  
Jacques Riad

Abstract Background Indications and cutoff value of deformities to determine surgical procedures for flexed knee gait are not clear. The aim was to determine the influence of none or mild, and moderate preoperative knee flexion contracture on the improvement of gait after orthopedic surgery in children with bilateral cerebral palsy (CP). Methods Inclusion criteria; bilateral CP, Gross Motor Function Classification System level I-III, and pre- and post operative-gait analysis. The 132 individuals identified were categorized into 2 groups based on the severity of knee flexion contracture (group 1: none or less than 11°; group 2: greater than or equal to 11°), and then matched according to the exact same soft tissue and/or bony orthopedic surgical procedures performed. The indication for surgery was to prevent progressive development of knee flexion contracture and stance phase flexed knee gait. Pre- and postoperative physical examination and gait analysis data were analyzed retrospectively. Results Sixty (30 + 30) children, with mean age 10.6 years in each group, were included. The average follow-up time was 17 months. Gait Deviation Index (GDI) improved in group 1 from mean 66 (SD 19) to 74 (15), p = 0.004, and in group 2 from 60 (13) to 69 (15), p = 0.001. Knee flexion in stance improved in group 1 from 21.4 (16.1) to 12.1 (16.0) degrees, p = 0.002, and in group 2 from 32.2 (14.2) to 17.0 (15.9), p = 0.001. Step length improved in both groups, p = 0.017 and p = 0.008, respectively. Only in group 2 significant improvement was noted in walking speed, p = 0.018 and standing function, Gross Motor Function Measure (GMFM-D), p = 0.001. Knee flexion contracture decreased in group 1 from mean 4.6 (5.3) to 2.1 (8.3) degrees, p = 0.071 and in group 2 from 17.2 (4.9) to 9.6 (9.3), p = 0.001. There was no statistical difference between groups in pre-post improvement of GDI or other variables, except GMFM-D. Conclusions Relative mild to moderate preoperative knee flexion contracture does not influence the short-term improvement of gait after orthopedic surgery in children with bilateral CP.


Author(s):  
Hira Abbasi ◽  
Abhishek Lal ◽  
Ammara Shamim Jaffrani

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design:  Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.


2021 ◽  
Vol 62 (3) ◽  
Author(s):  
Bui Dang Phuong Chi ◽  
Bui Dang Minh Tri ◽  
Bui Tung Hiep ◽  
Tran Nhat Anh

Objectives: To evaluate the rationality and effectiveness of clinical pharmacist’s intervention in the use of painkillers for post-operative pain treatment at the General Surgery Department of Cai Nuoc General Hospital. Objects and methods: Cross-sectional descriptive study on 172 patients (patients) undergoing surgery at General Surgery Department, Cai Nuoc General Hospital. Results: There were 38.95% of patients studied with adverse effects when using painkillers. The average duration of painkiller use after surgery was 5.6 ± 4.0 days. The differences in the mean time to take the drug between the 2 groups were statistically significant. VAS pain scores of the study samples tended to decrease gradually over 1, 3, 5, 7 days after surgery. On 2 research groups, in general, the average VAS score after 1 day surgery was 4.2 ± 1.9 points and after 7 days was 1.1 ± 0.8 points. Increase the reasonable rate in choosing drugs group 2 with reasonable rate was had a reasonable rate of 68.18%, much higher than group 1 with 46.43%. Conclusion: The incidence of adverse effects was low. The differences in the mean time to take the drug 70.45%, much higher than group 1 with 42.86%; drug dose, group 2 had reasonable rate was 82.95%, much higher than group 1 with 55.95%; the rationality of drug use, group 2 between the 2 groups were statistically significant. VAS pain scores of the study samples tended to decrease gradually over 1, 3, 5, 7 days after surgery. Increase the rationality of drug selection, drug dosage, and general rationality of post-operative pain treatment.


2019 ◽  
Author(s):  
Jason Wilhelm

Pain after surgery is one of greatest complaints patients have in the surgical process. It is important to decrease pain after surgery to promote a quicker recovery and minimize complications. Opioids alone have been used to manage post-operative pain in cardiac surgery; However, recently multimodal approaches to pain management are now being explored. This approach involves using multiple medications with varying mechanisms of action for pain relief in addition to decreased adverse effects. Ofirmev (IV acetaminophen) is a relatively new medication for use in cardiac surgery that has few contraindications and side effects. The purpose of this study was to investigate if utilizing the current pain management approach in addition to Ofirmev impacted pain scores in post-operative cardiothoracic patients in a non-experimental retrospective chart review. A two group comparative chart review was conducted for a total of 30 charts to meet inclusion criteria. Group 1 (n=15) received opioid only for pain management were compared to Group 2 (n=15) who received Ofirmev and opioids for pain management after cardiac surgery. Results showed that pain scores at hour 6 and 24 showed significance in favor of Group 2, the Ofirmev group. Results also showed Group 2, the Ofirmev group, consumed less morphine on average than Group 1, opioid only. Unexpectedly, length of stay was on average longer for the Ofirmev group than the non- ofirmev group. The research supports the need to utilize multimodal pain management and alternative techniques to manage pain. This study shows there is a need for further research for pain management with a multimodal approach in cardiac surgery.


2002 ◽  
Vol 96 (6) ◽  
pp. 1305-1309 ◽  
Author(s):  
Jun Tang ◽  
Shitong Li ◽  
Paul F. White ◽  
Xiaoguang Chen ◽  
Ronald H. Wender ◽  
...  

Background The analgesic efficacy and side effect profile of intravenous parecoxib, a novel cyclooxygenase type-2 (COX-2) inhibitor, was assessed in a double-blinded, placebo-controlled study involving patients undergoing major gynecologic surgical procedures. Methods After Institutional Review Board approval, 60 consenting women, American Society of Anesthesiologists (ASA) physical status I-III, undergoing lower abdominal surgery with a standardized general anesthetic technique were randomly assigned to receive one of three study medications: group 1 (control) received normal saline; group 2 received intravenous parecoxib, 20 mg; and group 3 received intravenous parecoxib, 40 mg. The initial dose of study medication was administered when the patient first requested pain medication after surgery. All patients had access to patient-controlled analgesia (PCA) with intravenous morphine, 1 or 2 mg, with a 6-min lockout period. Subsequent doses of the same study medication were administered at 12-h and 24-h intervals after the initial dose. The postoperative opioid analgesic requirement (PCA morphine usage), pain scores, pain relief scores, side effects, and need for supplemental medications (e.g., antiemetics, antipruritics, laxatives) were recorded. Results Compared with saline, intravenous parecoxib, 20 mg and 40 mg every 12 h, significantly decreased the PCA morphine usage during the first 6 h postoperatively (group 1, 25 +/- 13 mg; group 2, 16 +/- 11 mg; group 3, 17 +/- 10 mg) and at 12 h (group 1, 34 +/- 18 mg; group 2, 24 +/- 14 mg; group 3, 23 +/- 13 mg) and 24 h (group 1, 51 +/- 27 mg; group 2, 34 +/- 20 mg; group 3, 33 +/- 21 mg) after surgery. However, there were no significant differences in the patients' global evaluation of the study medications at 12 h and 24 h between those who received intravenous parecoxib (20 or 40 mg) and saline. Moreover, the postoperative pain scores and side effect profiles were similar in the three treatment groups. Conclusion Intravenous parecoxib (20 or 40 mg) was effective in decreasing the PCA opioid requirement after lower abdominal surgical procedures. However, it failed to improve pain management or reduce opioid-related side effects in the early postoperative period.


Author(s):  
Han-Jun Lee ◽  
Seong Hwan Kim ◽  
Nicolas Pujol ◽  
Yong-Beom Park

AbstractThe purpose of this study is to compare perception of leg length discrepancy (LLD) and clinical results of total knee arthroplasties (TKA) in patients with or without previous ipsilateral hip arthroplasty. Between 2008 and 2015, navigation-assisted TKA was performed in 43 patients with previous hip arthroplasty after hip fracture. After 1:3 propensity score matching was performed, 108 patients of primary navigation-assisted TKA (group 1) and 36 patients with hip arthroplasty (group 2) were included. Knee Society (KS) scores, Western Ontario and McMaster Universities Index (WOMAC) scores, and patients' satisfaction including perception of LLD were evaluated. Radiographic evaluation included mechanical axis, component position, and LLD. Logistic regression analysis was performed to find the factors that affect the clinical outcomes. No significant differences in radiologic and clinical evaluations, except for KS function score, patient's satisfaction and LLD (p< 0.001), were detected between the groups. LLD and its perception were significantly higher in group 2 (1.8 ± 3.4 mm in group 1 and 9.7 ± 4.1 mm in group 2, p = 0.000). Risk factors for the low KS function score were found as LLD (odds ratio [OR]: 1.403, p = 0.008) and previous hip arthroplasty itself (OR: 15.755, p = 0.002), but much higher OR was found in previous hip arthroplasty. Although the outcomes of TKA in patients with ipsilateral hip arthroplasty are comparable to those of primary TKA, LLD was high and patient's satisfaction and functional outcomes were low in patients with previous ipsilateral hip arthroplasty. Care should be taken when considering TKA in patients with previous hip arthroplasty. This is a Level III, case control study.


1999 ◽  
Vol 90 (5) ◽  
pp. 1354-1362 ◽  
Author(s):  
Marc De Kock ◽  
Philippe Gautier ◽  
Athanassia Pavlopoulou ◽  
Marc Jonniaux ◽  
Patricia Lavand'homme

Background The rationale of this study was to compare high-dose epidural clonidine with a more commonly used agent, such as bupivacaine. This was performed to give a more objective idea of the relative analgesic potency of epidural clonidine. Methods Sixty patients undergoing intestinal surgery during propofol anesthesia were studied. At induction, the patients received epidurally a dose of 10 micrograms/kg [corrected] clonidine in 7 ml saline followed by an infusion of 6 micrograms [corrected] x kg(-1) x h(-1) (7 ml/h) (group 1, n = 20), a dose of 7 ml bupivacaine, 0.5%, followed by 7 ml/h bupivacaine, 0.25% (group 2, n = 20), or a dose of 7 ml bupivacaine, 0.25%, followed by 7 ml/h bupivacaine, 0.125% (group 3, n = 20). Intraoperatively, increases in arterial blood pressure or heart rate not responding to propofol (0.5 mg/kg) were treated with intravenous alfentanil (0.05 mg/kg). Additional doses of propofol were given to maintain an adequate bispectral index. The epidural infusions were maintained for 12 h. In cases of subjective visual analogue pain scores up to 5 cm at rest or up to 8 cm during coughing, the patients were given access to a patient-controlled analgesia device. Results During anesthesia, patients in group 1 required less propofol than those in groups 2 and 3 (78 [36-142] mg vs. 229 [184-252] mg and 362 [295-458] mg; P &lt; 0.05) and less alfentanil than patients in group 3 (0 [0-0] mg vs. 11 [6-20] mg; P &lt; 0.05). Analgesia lasted 380 min (range, 180-645 min) in group 1 versus 30 min (range, 25-40 min) in group 2 and 22 min (range, 12.5-42 min) in group 3 (P &lt; 0.05). There was no suggestion of a hemodynamic difference among the three groups except for heart rates that were significantly reduced in patients in group 1. Sedation scores were significantly higher in this group during the first 2 h postoperatively. Conclusion Our results show that high doses of epidural clonidine potentiate general anesthetics and provide more efficient postoperative analgesia than the two bupivacaine dosage regimens investigated.


2009 ◽  
Vol 3 ◽  
pp. CMC.S2289 ◽  
Author(s):  
Taysir S. Garadah ◽  
Salah Kassab ◽  
Qasim M. Al-Shboul ◽  
Abdulhai Alawadi

Recent studies indicated a high prevalence of hyperglycemia in non-diabetic patients presenting with acute coronary syndrome (ACS). However, the threshold of admission glucose (AG) as a predictor of adverse events in ACS is unclear. Objective The aim of this study was to assess the threshold of admission glucose (AG) as a predictor of adverse events including Major Acute Cardiac Events (MACE) and mortality, during the first week of admitting patients presenting with ACS. Material and Methods The data of 551 patients with ACS were extracted and evaluated. Patients were stratified according to their blood glucose on admission into three groups: group 1: <7 mmol/L (n = 200, 36.3%) and group 2: >7 mmol/L and <15 mmol/L (n = 178, 32.3%) and group 3: ≥15 mmol/L (n = 173, 31.4%). Stress hyperglycemia was arbitrarily defined as AG levels > 7 mmol/L (group 2 and 3). Patients with ACS were sub-divided into two groups: patients with unstable angina (UA, n = 285) and those with ST segment elevation myocardial Infarction (STEMI, n = 266) and data were analyzed separately using multiple regression analysis. Results The mean age of patients was 59.7 ± 14.8 years and 63% were males. The overall mortality in the population was 8.5% (5.4% in STEMI and 3.1% in UA) patients. In STEMI patients, the odds ratio of stress hyperglycemia as predictor of mortality in group 3 compared with group 1 was 3.3 (CI 0.99-10.98, P < 0.05), while in group 2 compared with group 1 was 2.4 (CI: 0.75-8.07, P = 0.065) after adjustment for age and sex. Similarly, in UA patients, the odds ratio of stress hyperglycemia in group 3 compared with group 1 was 2.7 (CI 0.37-18.98, P < 0.05), while in group 2 compared with group 1 was 2.4 (CI: 0.4-15.2, P = 0.344) after adjustment for age and sex. The incidence of more than 2 MACE in both STEMI and UA patients was higher in group 3 compared with the other two groups. Regression analysis showed that history of DM, high level of LDL cholesterol, high level of HbA1c, and anterior infarction were significant predictors of adverse events while other risk factors such as BMI, history of hypertension and smoking were of no significance. Conclusion This study indicates that the stress hyperglycemia on admission is a powerful predictor of increased major adverse events and hospital mortality in patients with acute coronary syndrome.


Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384


2020 ◽  
Vol 19 (3) ◽  
pp. 80-91
Author(s):  
S. N. Schaeva ◽  
E. V. Gordeeva ◽  
E. A. Kazantseva

AIM: to evaluate the early and long-term results of emergency two-stage surgical procedures in patients with sigmoid colon cancer complicated by decompensated bowel obstruction.PATIENTS AND METHODS: the cohort study included 112 patients with sigmoid colon cancer complicated by bowel obstruction that underwent emergency two-stage surgical procedures in general surgical and coloproctological units in 2011-2017. The group 1 (n=60) included patients who, at the first stage, underwent Hartmann’s procedure, at the second stage – stoma reversal. The group 2 (n=52) included patients with a loop colostomy at the first stage and radical elective surgery as a second stage. The comparative analysis between the groups was carried out according to the following criteria: the type of surgery, the type of intestinal stoma, the rate and type of postoperative complications, postoperative mortality, resection status (R0/R1), the number of removed lymph nodes, the rate of adjuvant polychemotherapy (PChT).RESULTS: postoperative mortality in the group 1 was 3.33% (n=2) and occurred after the first main stage (Hartmann’s procedure), there were no deaths in group 2 (p=0.28). The procedures in group 2 fully met the criteria of oncological radicalism based on the number of lymph nodes examined and resection status (p<0.0001 and p<0.0001, respectively). Three-year overall survival at stage IIB in group 1 was 44.4% vs 75.2% in group 2 (p<0.0001); with IIIB in the 1st group – 60.3% vs 68.2% in group 2 (p=0.034); at IIIС in the 1st group – 35.7% vs 60.7% in the 2nd group (p=0.009). The 3-year disease – free survival at stage IIB in the 1st group was 41.7% vs 68.8% in the 2nd group (p<0.0001); with IIIB in the 1st group – 53.6% vs 64.5% in group 2 (p=0.036); at IIIС in the 1st group – 33.2% vs 60.8% in the 2nd group (p=0.023).CONCLUSION: for sigmoid colon cancer complicated by decompensated obstruction, in general hospitals the stage treatment with the colostomy at the first stage is preferable.


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