scholarly journals Opioid Use and the Risk of Respiratory Depression and Death in the Pediatric Population

2013 ◽  
Vol 18 (4) ◽  
pp. 269-276 ◽  
Author(s):  
Marianne R. Whittaker
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Respiratory Depression ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Increased Risk ◽  
Significant Difference

BACKGROUND Pediatric patients may be at an increased risk of adverse effects from various medications. Recently, there have been a number of serious adverse events, including several pediatric patients experiencing severe respiratory depression and death as a result of the use of codeine for pain control following tonsillectomy and adenoidectomy. OBJECTIVE To assess the safety of opioid agonists in pediatric patients undergoing operative procedures or have experienced trauma and to evaluate the risk of respiratory depression and death among this population. METHODS PubMed and Medline were searched to identify randomized controlled studies from 1994 to 2012 addressing postsurgery/trauma opioid use in pediatric patients. Relative risks and confidence intervals (CIs) were calculated using data available in clinical trials. RESULTS A total of 16 clinical trials were evaluated for this review. Randomized controlled trials included studies comparing opioids versus non-opioids for a variety of painful conditions. The relative risk of respiratory depression associated with opioid use in 1 trial was 1.63 (95% CI: 0.64–6.13). The remaining 15 trials reviewed described no significant difference in respiratory depression or adverse effects associated with treatment. No deaths were attributed to opioid use in any of these studies. CONCLUSION Opioid-associated respiratory depression was very rare and no deaths were reported in the reviewed studies. These findings under the well-defined conditions of controlled studies may not be the best means of determining overall opioid-associated side effects in pediatric patients.

scholarly journals Incidence of bleeding in children undergoing circumcision with ketorolac administration

2017 ◽  
Vol 12 (1) ◽  
pp. E6-9 ◽  
Author(s):  
Bruce Gao ◽  
Taylor Remondini ◽  
Navraj Dhaliwal ◽  
Adrian Frusescu ◽  
Premal Patel ◽  
...  
Keyword(s):  
Emergency Department ◽  
Adverse Effects ◽  
Pain Control ◽  
Pediatric Patients ◽  
Surgical Patients ◽  
Risk Of Bleeding ◽  
Perioperative Bleeding ◽  
Number Of Patients ◽  
Increased Risk ◽  
Significant Difference

Introduction: Circumcision is the most common surgical procedure performed by pediatric urologists. Ketorolac has been shown to have an efficacy similar to morphine in multimodal analgesic regimens without the commonly associated adverse effects. Concerns with perioperative bleeding limit the use of ketorolac as an adjunct for pain control in surgical patients. As such, we sought to evaluate our institutional outcomes with respect to ketorolac and postoperative bleeding.Methods: We retrospectively reviewed all pediatric patients undergoing circumcision from January 1, 2014 to December 31, 2015 at the Alberta Children’s Hospital. Demographics, perioperative analgesic regimens, and return to emergency department or clinic for bleeding were gathered through chart review.Results: A total of 475 patients undergoing circumcisions were studied, including 150 (32%) who received perioperative ketorolac and 325 (68%) who received standard analgesia. Patients receiving ketorolac were more likely to return to the emergency department or clinic for bleeding (ketorolac group 19/150 [13%], non-ketorolac group 16/325 [5.0%]; p=0.005). Patients receiving ketorolac were more likely to have postoperative sanguineous drainage (ketorolac group 96/150 [64%], non-ketorolac group 150/325 [46%]; p<0.001). There was no significant difference in the number of patients requiring postoperative admission or further medical intervention.Conclusions: Although a promising analgesic, ketorolac requires additional investigation for safe usage in circumcisions due to possible increased risk of bleeding.

scholarly journals A Systematic Review on Vitex negundo (NIRPROMP formulations) for the Treatment of Acute Cough of Mild to Moderate Severity in Pediatric Patients

2020 ◽  
Vol 54 (1) ◽  
Author(s):  
Daisy-Mae Alegado-Bagaoisan ◽  
Mary Christine R. Castro ◽  
Jaime M. Purificacion
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Pediatric Patients ◽  
Controlled Trials ◽  
Vitex Negundo ◽  
Efficacy And Safety ◽  
Acute Cough ◽  
Moderate Severity ◽  
Randomized Controlled

Objective. The aim of this systematic review was to evaluate the efficacy and safety of Vitex negundo (lagundi) for the treatment of acute cough of mild to moderate severity among pediatric patients.Methods. A systematic review of randomized controlled trials (RCTs) comparing lagundi to placebo for acute cough of mild to moderate severity in children and adolescents aged two to twenty one years in ambulatory settings was performed. Authors of unpublished clinical trials with existing patent numbers were contacted and permission was obtained to access and include their studies in this review. Results. Seven studies were included, with a total of 308 participants. Lagundi increased the peak exploratory flow rate (PEFR) at the end of therapy compared with placebo but this was not statistically significant (p=0.36). The increase in PEFR was consistent with the results of the mechanistic isolated tissue studies that showed bronchodilating effect of lagundi. Studies using lagundi syrup showed decrease in the frequency of cough by 44–71%. Conclusion. Lagundi therapy in acute cough of mild to moderate severity among pediatric patients has a bronchodilating effect and decreases the frequency and duration of coughing, with no serious adverse effects.

Effectiveness of ketamine-propofol sedation for reducing respiratory adverse events compared to propofol sedation: A Meta-Analysis of randomized controlled trials

2020 ◽  
Author(s):  
Ting Wen ◽  
Shibiao Chen ◽  
Lili Zhao ◽  
Yang Zhang
Keyword(s):  
Adverse Events ◽  
Respiratory Depression ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Cochrane Library ◽  
Central Apnea ◽  
Propofol Sedation ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Abstract ObjectiveThe objective of our review was to determine whether ketamine-propofol had an advantage in reducing respiratory adverse events compared to propofol for procedural sedation.MethodsElectronic databases including Web of Science, The Cochrane Library, PubMed, Medline, Embase, Google Scholar were searched to identify potential studies. All randomized controlled studies from their inception to May 2020 comparing ketamine-propofol sedation with propofol sedation were identified. Pooled analysis and subgroup analysis were conducted using Stata software. The quality assessment of all included studies was completed by using the Cochrane Collaboration's tool for assessing risk of bias.ResultsA total of 21 studies involving 3669 individuals were included. The most common respiratory adverse events (all reported per 100 sedations) were: hypoxia(KP 10.9%; P 17.0%), respiratory depression(KP 6.9%; P 14.9%), central apnea(KP 5.9%; P 8.0%). Pooling these 21 studies, subjects with ketamine-propofol had significant lower incidence of respiratory adverse events than those with propofol (RR: 0.55, 95% CI: 0.41–0.74). When stratified by study population, no significant difference was observed in reducing respiratory adverse events between ketamine-propofol sedation and propofol sedation among children (RR: 0.74, 95% CI: 0.46–1.20). However, significant differences were discerned definitely among adults(RR: 0.48, 95% CI: 0.39–0.60).ConclusionIn summary, Our results suggested hypoxia, respiratory depression, central apnea were most common respiratory adverse events in propofol sedation. However, ketamine-propofol sedation had an advantage in reducing the incidence of respiratory adverse events compared with propofol sedation, especially in adults.

Continuous and Extended Infusions of β-Lactam Antibiotics in the Pediatric Population

2012 ◽  
Vol 46 (11) ◽  
pp. 1537-1546 ◽  
Author(s):  
Mary Covington Walker ◽  
Weng Man Lam ◽  
Kalen B Manasco
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Continuous Infusion ◽  
Pediatric Patients ◽  
Case Reports ◽  
Pediatric Population ◽  
Case Series ◽  
Current Evidence ◽  
Pharmacokinetic Studies ◽  
Randomized Controlled

OBJECTIVE: To conduct a systematic review of available data on the use of extended or continuous infusion of β-lactam and monobactam therapy in the pediatric population (aged 0–18 years). DATA SOURCES: A literature search was performed using PubMed (1975-May 2012), International Pharmaceutical Abstracts (1970-May 2012), and Web of Science (1977-May 2012) to identify studies for inclusion. In addition, reference citations from identified publications were reviewed. The following search terms were used: pediatric, children, neonate, infant, adolescent, β-lactam, cephalosporin, carbapenem, penicillin, monobactam, continuous infusion, extended infusion, and/or prolonged infusion. Individual names of drugs in each class of antibiotics were also included in the search. STUDY SELECTION AND DATA EXTRACTION: Randomized controlled clinical trials, pharmacokinetic/pharmacodynamic studies, observational studies, and case reports involving pediatric patients who received extended or continuous infusion of β-lactam or monobactam antibiotics were reviewed. Only English-language publications were included. DATA SYNTHESIS: One randomized controlled clinical trial, 5 pharmacokinetic studies, 2 pharmacodynamic studies using Monte Carlo simulation, 1 case series, and 7 case reports were included in the analysis. The cephalosporin class has been studied the most and currently represents the only clinical trial using a continuous infusion dosing strategy in pediatric patients. There is limited clinical evidence available to support the use of extended or continuous infusion of β-lactam antibiotics in the pediatric population. Pharmacodynamic studies conducted in this population mirror the current evidence in adults for cefepime and meropenem. The single prospective clinical trial using continuous infusion of ceftazidime failed to demonstrate any clinical benefit over traditional dosing; however, there was equal efficacy. CONCLUSIONS: More well-designed prospective clinical trials are required to determine the role of extended or continuous infusion of β-lactam antibiotics in treatment of pediatric patients.

scholarly journals Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Vinod Solipuram ◽  
Akhila Mohan ◽  
Roshniben Patel ◽  
Ruoning Ni
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Randomized Controlled Trials ◽  
Random Effect ◽  
Janus Kinase ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Significant Difference ◽  
Risk Of Malignancy

Abstract Background Rheumatoid arthritis (RA) is a systemic autoimmune disease. The combination therapy of methotrexate (MTX) and Janus kinase inhibitor (JAKi) is commonly used. Patients with RA are at increased risk of malignancy, however, it remains unclear whether the combination therapy is associated with a higher risk. Objective To assess the malignancy risk among patients with RA receiving combination therapy of JAKi and MTX compared to MTX alone. Methods PubMed, Cochrane and Embase were thoroughly searched for randomized controlled trials (RCTs) in patients with RA receiving JAKi and MTX, from inception to July 2020. Primary endpoints were malignancy events, Non melanomatous skin cancer (NMSC) and malignancy excluding NMSC and secondary endpoints were serious adverse events (SAE), deaths. Risk ratio (RR) and 95% CI were calculated using the Mantel–Haenszel random-effect method. Results 659 publications were screened and 13 RCTs with a total of 6911 patients were included in the analysis. There was no statistically significant difference in malignancy [RR = 1.42; 95% CI (0.59, 3.41)], neither NMSC [RR = 1.44 (0.36, 5.76)] nor malignancies excluding NMSC [RR = 1.12 (0.40, 3.13)]. No statistically significant difference between the two groups for SAE [RR = 1.15 (0.90, 1.47)] and deaths [RR = 1.99 (0.75, 5.27)] was found. Conclusion The adjunction of JAKi to MTX is not associated with an increased risk of malignancy when compared to MTX alone. There is no increased risk of SAE and deaths when compared to MTX alone in patients with RA.

scholarly journals The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (10) ◽  
pp. 3151
Author(s):  
Chang-Hoon Koo ◽  
Jin-Woo Park ◽  
Jung-Hee Ryu ◽  
Sung-Hee Han
Keyword(s):  
Virtual Reality ◽  
Randomized Controlled Trials ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Virtual reality (VR), a technology that provides a stimulated sensory experience, has recently been implemented in various fields of medicine. Several studies have investigated the efficacy of VR on preoperative anxiety. The purpose of this meta-analysis was to validate whether VR could relieve preoperative anxiety in patients undergoing surgery. Electronic databases were searched to identify all randomized controlled trials (RCTs) investigating the effect of VR on preoperative anxiety. The primary outcome was defined as the preoperative anxiety scores. We estimated the effect size using the standard mean difference (SMD) with a 95% confidence interval (CI) using a random effect model. Ultimately, 10 RCTs, with a total of 813 patients, were included in the final analysis. Preoperative anxiety was significantly lower in the VR group than in the control group (SMD −0.64, 95% CI −1.08 to −0.20, p = 0.004). In a subgroup analysis, the preoperative anxiety scores were lower in the VR group than in the control group in pediatric patients (SMD −0.71, 95% CI −1.14 to −0.27, p = 0.002), whereas a significant difference was not observed between the two groups in adult patients (p = 0.226). The results of this meta-analysis indicated that VR could decrease preoperative anxiety, especially in pediatric patients.

scholarly journals Intravenous paracetamol versus ketorolac for pain attenuation in patients with renal colic; a randomized, single blind and controlled clinical trial

2020 ◽  
Vol 9 (2) ◽  
pp. e10-e10
Author(s):  
Arash Ardestani Zadeh ◽  
Davood Arab ◽  
Mohammadreza Moonesan ◽  
Majid Mirmohammadkhani ◽  
Pouya Morid
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Renal Colic ◽  
Vital Signs ◽  
Analgesic Efficacy ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Intravenous Paracetamol ◽  
Significant Difference ◽  
Single Blind

Introduction: Pain control is an essential care for patients with renal colic in emergency wards. Objectives: This study aimed to compare the analgesic efficacy of intravenous (IV) paracetamol (PC) versus ketorolac (KET) for patients with renal colic. Patients and Methods: In a randomized controlled clinical trial, 110 patients with renal colic referred to the emergency department of Kosar hospital, Semnan between October 2015 and June 2016 were selected. Eighty-eight patients were divided into two groups (44 patients in each group) of PC (1 g/IV) and KET (30 mg/IV). One patient in each group was excluded during the study. Vital signs and pain severity (measured by visual analogue scale [VAS]) of all patients were recorded at admission time 0, 20, 40 and 60 minutes after treatment. Then, the results were compared in two groups. Results: The results showed that at the time of 0, 20, 40 and 60 minutes after the administration of the PC and KET drugs, no significant difference was seen in severity of pain based on VAS score between the two groups (P<0.05). Moreover, there were no significant differences in the vital signs of two groups (P<0.05). No adverse effects were reported in each group. Conclusion: In conclusion, the use of IV-PC and KET in patients with renal colic had similar pain relieving effects without any adverse effects.

scholarly journals Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial

2018 ◽  
Vol 7 (3) ◽  
pp. 381
Author(s):  
Tanmoy Kanti Goswami ◽  
Pradip Kumar Ghoshal ◽  
Avijit Hazra ◽  
Asish Biswas
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
Womac Score ◽  
Open Label ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Considerable Morbidity

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.

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