Nonsteroidal antiinflammatory drugs versus tramadol in pain management following transsphenoidal surgery for pituitary adenomas: a randomized, double-blind, noninferiority trial

2021 ◽  
pp. 1-10
Author(s):  
Xiaopeng Guo ◽  
Zihao Wang ◽  
Lu Gao ◽  
Wenbin Ma ◽  
Bing Xing ◽  
...  
Keyword(s):  
Pain Management ◽  
Adverse Events ◽  
Pituitary Adenomas ◽  
Transsphenoidal Surgery ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
P Value ◽  
Opioid Use ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
Vas Scores

OBJECTIVE Opioid-minimizing or nonopioid therapy using nonsteroidal antiinflammatory drugs (NSAIDs) or tramadol has been encouraged for pain management. This study aimed to examine the noninferiority of NSAIDs to tramadol for pain management following transsphenoidal surgery for pituitary adenomas in terms of analgesic efficacy, adverse events, and rescue opioid use. METHODS This was a randomized, single-center, double-blind noninferiority trial. Patients 18–70 years old with planned transsphenoidal surgery for pituitary adenomas were randomly assigned (in a 1-to-1 ratio) to receive NSAIDs (parecoxib injection and subsequent loxoprofen tablets) or tramadol (tramadol injection and subsequent tramadol tablets). The primary outcome was pain score assessed by a visual analog scale (VAS) for 24 hours following surgery; the secondary outcomes were VAS scores for 48 and 72 hours. Other prespecified outcomes included nausea, vomiting, dizziness, upset stomach, skin rash, peptic ulcer, gastrointestinal bleeding, and pethidine use to control breakthrough pain. Noninferiority of NSAIDs to tramadol was established if the upper limit of the 95% confidence interval (CI) of the VAS score difference was < 1 point and the rate difference of adverse events and pethidine use < 5%. The superiority of NSAIDs was assessed when noninferiority was verified. All analyses were performed on an intention-to-treat basis. RESULTS Two hundred two patients were enrolled between November 1, 2020, and May 31, 2021 (101 in the NSAIDs group, 101 in the tramadol group). Baseline characteristics between groups were well balanced. Mean VAS scores for 24 hours following transsphenoidal surgery were 2.6 ± 1.8 in the NSAIDs group and 3.5 ± 2.1 in the tramadol group (−0.9 difference, 95% CI −1.5 to −0.4; p value for noninferiority < 0.001, p value for superiority < 0.001). Noninferiority and superiority were also achieved for both secondary outcomes. VAS scores improved over time in both groups. Incidences of nausea (39.6% vs 61.4%, p = 0.002), vomiting (3.0% vs 42.6%, p < 0.001), and dizziness (12.9% vs 47.5%, p < 0.001) were significantly lower, while incidence of upset stomach (9.9% vs 2.0%, p = 0.017) was slightly higher in the NSAIDs group compared with the tramadol group. The percentage of opioid use was 4.0% in the NSAIDs group and 15.8% in the tramadol group (−11.8% difference, 95% CI −19.9% to −3.7%; p value for noninferiority < 0.001, p value for superiority = 0.005). CONCLUSIONS NSAIDs significantly reduced acute pain following transsphenoidal surgery, caused few adverse events, and limited opioid use compared with tramadol.

A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD

2018 ◽  
Vol 24 (2) ◽  
pp. 318-325 ◽  
Author(s):  
Judy P. M. van Stralen
Keyword(s):  
Executive Function ◽  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
P Value ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Stimulant Therapy

Objective: To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD. Method: In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs. Results: Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003). There were no serious adverse events and no new safety signals. Conclusion: Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.

A randomized, controlled clinical trial of ketoprofen for sickle-cell disease vaso-occlusive crises in adults

Blood ◽  
2009 ◽  
Vol 114 (18) ◽  
pp. 3742-3747 ◽  
Author(s):  
Pablo Bartolucci ◽  
Tony El Murr ◽  
Françoise Roudot-Thoraval ◽  
Anoosha Habibi ◽  
Aline Santin ◽  
...  
Keyword(s):  
Pain Relief ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Controlled Clinical Trial ◽  
Cell Disease ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
End Points

Abstract Vaso-occlusive crisis (VOC) is the primary cause of hospitalization of patients with sickle-cell disease. Treatment mainly consists of intravenous morphine, which has many dose-related side effects. Nonsteroidal antiinflammatory drugs have been proposed to provide pain relief and decrease the need for opioids. Nevertheless, only a few underpowered trials of nonsteroidal antiinflammatory drugs for sickle-cell VOC have been conducted, and conflicting results were reported. We conducted a phase 3, double-blind, randomized, placebo-controlled trial with ketoprofen (300 mg/day for 5 days), a nonselective cyclooxygenase inhibitor, for severe VOC in adults. A total of 66 VOC episodes were included. The primary efficacy outcome was VOC duration. The secondary end points were morphine consumption, pain relief, and treatment failure. Seven VOC episodes in each group were excluded from the analysis because of treatment failures. No significant between-group differences were observed for the primary outcome or the secondary end points. Thus, although ketoprofen was well-tolerated, it had no significant efficacy as treatment of VOC requiring hospitalization. These findings argue against its systematic use in this setting.

scholarly journals Corticosteroid or Nonsteroidal Antiinflammatory Drugs for the Treatment of Acute Gout: A Systematic Review of Randomized Controlled Trials

2017 ◽  
Vol 45 (1) ◽  
pp. 128-136 ◽  
Author(s):  
Christy Amanda Billy ◽  
Ricky Tanujaya Lim ◽  
Marinella Ruospo ◽  
Suetonia C. Palmer ◽  
Giovanni F.M. Strippoli
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Evaluation System ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Response To Therapy ◽  
Controlled Trials ◽  
Acute Gout ◽  
First Line ◽  
Antiinflammatory Drugs ◽  
Randomized Controlled

Objective.Nonsteroidal antiinflammatory drugs (NSAID) are used as first-line agents to treat acute gout. Recent trials suggest a possible first-line role for corticosteroids.Methods.We conducted a metaanalysis of randomized controlled trials (RCT) evaluating corticosteroid versus NSAID therapy (nonselective and selective) as treatment for acute gout. MEDLINE, EMBASE, and CENTRAL were systematically searched through August 2016. Outcomes included pain, bleeding, joint swelling, erythema, tenderness, activity limitation, response to therapy, quality of life, time to resolution, supplementary analgesics, and adverse events. Evidence quality was summarized using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system.Results.Six eligible trials (817 patients) were identified. The mean study followup was 15 days (range 4–30). Risks of bias were generally low. In low- to moderate-quality evidence, corticosteroids did not have different effects on pain score at < 7 days [standardized mean difference (SMD) −0.09, 95% CI −0.26 to 0.08] or at ≥ 7 days (SMD 0.32, 95% CI −0.27 to 0.92) when compared with NSAID. There was no evidence of different risks of gastrointestinal bleeding [relative risk (RR) 0.09, 95% CI 0.01–1.67]. There was no evidence of different responses to therapy on pain at < 7 days (RR 1.07, 95% CI 0.80–1.44) and ≥ 7 days, time to disease resolution, or number of supplementary analgesics used (MD 2.10 drugs, 95% CI −1.01 to 5.21). There was a lower risk of indigestion (RR 0.50, 95% CI 0.27–0.92), nausea (RR 0.25, 95% CI 0.11–0.54), and vomiting (RR 0.11, 95% CI 0.02–0.56) with corticosteroid therapy.Conclusion.There is no evidence that corticosteroids and NSAID have different efficacy in managing pain in acute gout, but corticosteroids appear to have a more favorable safety profile for selected adverse events analyzed in existing RCT.

Nonselective Nonsteroidal Antiinflammatory Drugs and Cardiovascular Risk: Are They Safe?

2007 ◽  
Vol 41 (7-8) ◽  
pp. 1163-1173 ◽  
Author(s):  
Javier C Waksman ◽  
Aaron Brody ◽  
Scott D Phillips
Keyword(s):  
Cardiovascular Risk ◽  
Significant Risk ◽  
Case Control ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Double Blind Study ◽  
Case Control Studies ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
Nsaid Treatment ◽  
Meta Analyses

Objective: To assess possible cardiovascular risks associated with use of nonselective nonsteroidal antiinflammatory drugs (NSAIDs). Data Sources: Medline and Embase were searched from January 1985 through April 2007 and relevant studies were retrieved. Study Selection and Data Extraction: Peer-reviewed, prospective, double-blind, case–control, and cohort-design studies published in the English language literature were considered eligible for review. Previous meta-analyses and systematic reviews were also analyzed. In total, 17 case–control studies; 9 cohort studies; 1 prospective, double-blind study; 3 meta-analyses; and 1 systematic review of observational studies were identified. Data Synthesis: Three studies were prospective and the remainder consisted of observational, retrospective studies, with most reporting acute fatal or nonfatal myocardial infarction as the cardiovascular endpoint. Among the nonselective NSAIDs, diclofenac appears to pose the highest risk for cardiovascular toxicity; other agents trend toward a neutral effect with respect to cardiovascular risk. Although the data are suggestive, it remains unclear whether naproxen provides protective cardiovascular effects among patients on chronic therapy. Conclusions: Currently available data are insufficient for defining evidence-based clinical guidelines for the use of NSAIDs, and the need for additional research, specifically randomized controlled trials, is evident. Diclofenac demonstrates a significant risk while naproxen appears to pose the lowest, albeit nonsignificant, risk for cardiovascular morbidity. Although the current clinical evidence may not warrant recommending naproxen as the preferred NSAID treatment, it may be prudent to avoid diclofenac for patients with cardiovascular risk factors requiring NSAID treatment.

scholarly journals A 40 Month Double-Blind, Randomized, Placebo-Controlled Trial on the Effect of BCc1 Nanomedicine on Survival of Metastatic and Non-Metastatic Gastric Cancer Patients

2021 ◽  
Author(s):  
Maryam Hafizi ◽  
Somayeh Kalanaky ◽  
Hassan Moaiery ◽  
Sajad Noorian ◽  
Maryam Khayamzadeh ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Metastatic Gastric Cancer ◽  
P Value ◽  
Double Blind ◽  
Gastric Cancer Patients

Abstract Background: Complementary experiments on nanomedicines as proper candidates for the control and treatment of cancer are widely being conducted nowadays. In the previous study, the effect of BCc1 nanomedicine, which is synthetized based on nanochelating technology, on overall survival (OS) and quality of life of gastric cancer patients was evaluated after 18 months of consumption. The OS of the same patients is reported in this study after 40 months. Methods: A double-blind, randomized, placebo-controlled, parallel, multicenter design was used in this study. 123 metastatic and non-metastatic gastric cancer patients of both genders (between 25 and 85 years old) participated in this experiment to evaluate their OS after consuming BCc1 for 40 months and to identify the adverse events of this nanomedicine. Results: The median OS of metastatic patients was 257 days in the BCc1 group [95% confidence interval (CI): 144. 142-369.858], while it was 161 days in the placebo [95% CI: 118.462-203.538]; hazard ratio (HR): 0.802 [95% CI: 0.483-1.333] (P-Value = 0.395). Similarly, the median OS of non-metastatic patients was 718 days in the BCc1 group [95% CI; 577.706-860.213], while it was 520 days in the placebo [95% CI: 460.280- 580.690]; HR: 0.807 [95% CI: 0.343,1.902] (P-Value = 0.624). There was no evidence of adverse events after 40 months.Conclusion: The OS improvement of metastatic and non-metastatic gastric cancer patients in the previous (18 months of follow-up) and current (40 months of follow-up) studies showed that BCc1 can be used along with base treatments to improve cancer patients’ OS. Trial registration: IRCTID, IRCT2017101935423N1.Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1.

scholarly journals Perspectives of pain specialists, patients, and family members on long-term opioid use for chronic non-cancer pain: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rattaphol Seangrung ◽  
Thongchai Tempeetikul ◽  
Supasit Pannarunothai ◽  
Supalak Sakdanuwatwong
Keyword(s):  
Pain Management ◽  
Pain Relief ◽  
Qualitative Study ◽  
Adverse Events ◽  
Cancer Pain ◽  
Family Members ◽  
Opioid Therapy ◽  
Functional Improvement ◽  
Opioid Use

Abstract Background Opioids are currently prescribed for chronic non-cancer pain (CNCP), and some patients use opioids continuously for long-term treatment. Stakeholders’ awareness about long-term opioid therapy is essential for improving the safety and effectiveness of pain treatment. The purpose of this study is to explore the perspectives of pain specialists, patients, and family caregivers about long-term opioid use in CNCP management. Methods This study was a qualitative study and adhered to the COREQ guidelines. Pain specialists (n = 12), patients (n = 14), and family members (n = 9) were recruited to the study by purposive sampling at the Pain Clinic of Ramathibodi Hospital. Semi-structured interviews were recorded, verbatim transcribed, conceptually coded, and analyzed using Atlas.ti 8.0. Results All groups of participants described opioids as non-first-line drugs for pain management. Opioids should be prescribed only for severe pain, when non-opioid pharmacotherapy and non-pharmacological therapies are not effective. Patients reported that the benefits of opioids were for pain relief, while physicians and most family members highlighted that opioid use should improve functional outcomes. Physicians and family members expressed concerns about opioid-related side effects, harm, and adverse events, while patients did not. Patients confirmed that they would continue using opioids for pain management under supervision. However, physicians stated that they would taper off or discontinue opioid therapy if patients’ pain relief or functional improvement was not achieved. Both patients and family members were willing to consider non-pharmacological therapies if potential benefits existed. Patient education, doctor–patient/family relationships, and opioid prescription policies were proposed to enhance CNCP management. Conclusion Long-term opioid therapy for CNCP may be beneficial in patients who have established realistic treatment goals (for both pain relief and functional improvement) with their physicians. Regular monitoring and evaluation of the risks and benefits, adverse events, and drug-related aberrant behaviors are necessary. Integrated multimodal multidisciplinary therapies and family member collaborations are also important for improving CNCP management.

Nonsteroidal antiinflammatory drugs for postoperative pain management after lumbar spine surgery: a meta-analysis of randomized controlled trials

2008 ◽  
Vol 9 (1) ◽  
pp. 22-31 ◽  
Author(s):  
Kitti Jirarattanaphochai ◽  
Surachai Jung
Keyword(s):  
Lumbar Spine ◽  
Pain Management ◽  
Spine Surgery ◽  
Meta Analysis ◽  
Opioid Analgesics ◽  
Postoperative Pain Management ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Cochrane Library ◽  
Lumbar Spine Surgery ◽  
Antiinflammatory Drugs

Object The authors undertook this meta-analysis to assess the efficacy and safety of nonsteroidal antiinflammatory drugs (NSAIDs) in addition to opioid analgesics on perioperative pain management in lumbar spine surgery. Methods The authors searched MEDLINE, Excerpta Medica (EMBASE), The Cochrane Library, CINAHL, PsycINFO, Allied and Complementary Medicine (AMED), and Science Citation Index Expanded databases. In addition, they manually searched key journals and their references. They included randomized trials comparing the use of NSAIDs in addition to opioid analgesics versus opioid analgesics alone after posterior lumbar discectomy, laminectomy, or spinal fusion. Two independent reviewers performed an assessment of the quality of the methods. Results Seventeen studies comprising 400 patients who received NSAIDs in addition to opioid analgesics and 389 patients receiving opioid analgesics alone were included. Patients receiving NSAIDs in addition to opioid analgesics had lower pain scores and consumed fewer opioids than the group receiving opioid analgesics alone. There was no difference in the incidence of adverse effects. Conclusions This meta-analysis provides evidence that the addition of NSAIDs to opioid analgesics in lumbar spine surgery provided better pain control than opioid analgesics alone.

Effects of Nonsteroidal Antiinflammatory Drugs on Patient-controlled Analgesia Morphine Side Effects

2005 ◽  
Vol 102 (6) ◽  
pp. 1249-1260 ◽  
Author(s):  
Emmanuel Marret ◽  
Okba Kurdi ◽  
Paul Zufferey ◽  
Francis Bonnet ◽  
David C. Warltier
Keyword(s):  
Adverse Effects ◽  
Meta Analysis ◽  
Postoperative Nausea And Vomiting ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Nausea And Vomiting ◽  
Morphine Consumption ◽  
Patient Controlled Analgesia ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
Sparing Effect

Nonsteroidal antiinflammatory drugs (NSAIDs) are commonly combined with intravenous morphine patient-controlled analgesia to relieve postoperative pain. NSAIDs have a documented 30-50% sparing effect on morphine consumption. However, most of the studies have not demonstrated a decrease in morphine adverse effects. A meta-analysis of randomized controlled trials was performed to evaluate the risk of morphine adverse effects in patients treated with NSAIDs. Twenty-two prospective, randomized, double-blind studies including 2,307 patients were selected. NSAIDs decreased significantly postoperative nausea and vomiting by 30%, nausea alone by 12%, vomiting alone by 32% and sedation by 29%. A regression analysis yielded findings indicating that morphine consumption was positively correlated with the incidence of nausea and vomiting. Pruritus, urinary retention, and respiratory depression were not significantly decreased by NSAIDs.

Prospective, Double-blind Evaluation of Perioperative Intravenous Acetaminophen and Ketorolac for Postoperative Pain and Opioid Consumption After Endoscopic Carpal Tunnel Release

Hand ◽  
2020 ◽  
pp. 155894472090650
Author(s):  
Elizabeth C. Truelove ◽  
Eva Urrechaga ◽  
Carmella Fernandez ◽  
John R. Fowler
Keyword(s):  
Pain Management ◽  
Postoperative Pain ◽  
Carpal Tunnel ◽  
Carpal Tunnel Release ◽  
Opioid Consumption ◽  
Controlled Study ◽  
Opioid Use ◽  
Double Blind ◽  
Pain Scores ◽  
Endoscopic Carpal Tunnel Release

Background: The current opioid epidemic highlights the need for pain management strategies to decrease or eliminate postoperative use of opioid medications. The purpose of this study was to determine if perioperative administration of intravenous (IV) acetaminophen and/or IV ketorolac decreases postoperative pain and opioid consumption after endoscopic carpal tunnel release. Methods: In all, 44 subjects were enrolled in this randomized, double-blind, placebo-controlled study from October 2015 to April 2017 and divided into 4 treatment arms: placebo, IV acetaminophen, IV ketorolac, or both IV acetaminophen and IV ketorolac. Patients recorded pain at 8-hour intervals on an 11-point scale and daily opioid use for 7 days after surgery. Analysis of variance and Kruskal-Wallis tests were used to compare mean pain scores and opioid consumption. Results: Mean pain scores over the 7-day study period were lower in the placebo and IV acetaminophen groups. Patients in the placebo and acetaminophen groups reported less pain than those in the ketorolac and combination groups on postoperative days 6 and 7. Patients administered IV acetaminophen had lower daily mean opioid usage. In all, 50% of the patients did not take any opioids after surgery. Conclusions: There are small, statistically significant differences in postoperative pain and opioid consumption supporting the use of IV acetaminophen for pain control after endoscopic carpal tunnel release, though these results are likely not clinically relevant. We recommend continued investigation into multimodal pain management in upper extremity surgery as well as limiting the number and quantity of opioid prescriptions provided to patients postoperatively.

scholarly journals A nemszteroid gyulladáscsökkentő gyógyszerek kiválasztásának szempontjai a biztonságosság tükrében

2018 ◽  
Vol 159 (44) ◽  
pp. 1783-1788
Author(s):  
Szilvia Szamosi
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Antiinflammatory Drugs ◽  
Younger Patients ◽  
Professional Societies ◽  
Hungarian Society ◽  
History Of ◽  
Antiinflammatory Effects ◽  
Professional Guidelines

Abstract: Nonsteroidal antiinflammatory drugs are the most commonly used painkillers. Both analgetic and antiinflammatory effects of these medications are important in the treatment of rheumatic diseases. Despite their well-recognized efficacy, professional societies recommend using nonsteroidal antiinflammatory drugs with caution, balancing the various potential gastrointestinal, cardiovascular and renal adverse events. Clinicians should consider advanced age and history of concomitant diseases even in younger patients when considering treatment choice. As our Hungarian society is aging, prescribers must be aware of the basic pharmacodynamics and pharmacokinetics of nonsteroidal antiinflammatory drugs as well as drug interactions and potential adverse effects should be taken into consideration when using them according to the latest professional guidelines. Orv Hetil. 2018; 159(44): 1783–1788.

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