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Croatian Medical Journal Aug 2023To investigate whether IV lidocaine improves emergence, early recovery, and late recovery after general anesthesia in women who undergo breast surgery. (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of an intravenous lidocaine bolus before tracheal extubation on recovery after breast surgery - Lidocaine at the End (LATE) study: a randomized controlled clinical trial.
AIM
To investigate whether IV lidocaine improves emergence, early recovery, and late recovery after general anesthesia in women who undergo breast surgery.
METHODS
Sixty-seven women with American Society of Anesthesiologists physical status I-II, scheduled for breast surgery were randomized to receive an IV lidocaine 1.5 mg/kg bolus (n=34) or saline placebo (n=33) before tracheal extubation. Anesthesia was induced with thiopental, vecuronium, and fentanyl, and maintained with sevoflurane~1 MAC and 50% nitrous-oxide in oxygen. No postoperative nausea and vomiting (PONV) prophylaxis was given. Time to extubation, bucking before extubation, and quality of emergence, as well as early and late recovery (coughing post-extubation, sore throat, PONV, and pain scores) within 24 hours postoperatively were evaluated. Diclofenac and meperidine were used for the treatment of pain and metoclopramide for PONV.
RESULTS
The groups did not significantly differ in demographics, intraoperative data, or PONV risk scores. Extubation was~8 minutes in both groups. Patients who received IV lidocaine had significantly smoother recovery, both statistically and clinically; they had better extubation quality scores (1.5 [1-3] vs 3 [1-5], P<0.001), less bucking before extubation (38% vs 91%, P<0.001), less coughing after extubation (at 1 min 18% vs 42%, P=0.026; and at 24 hours 9% vs 27%, P=0.049), and less sore throat (6% vs 48%, P<0.001). Late PONV decreased (3% vs 24%, P=0.013). There were no differences in pain scores and treatment.
CONCLUSION
In women who underwent breast surgery, IV lidocaine bolus administered just before extubation attenuated bucking, cough and sore throat, and PONV for 24 hours after general anesthesia, without prolonging the emergence.
Topics: Humans; Female; Airway Extubation; Lidocaine; Postoperative Nausea and Vomiting; Pain; Pharyngitis; Breast Neoplasms
PubMed: 37654034
DOI: 10.3325/cmj.2023.64.222 -
Journal of Orthopaedic Surgery and... Oct 2023Acupuncture has been used to relieve chronic pain in patients with knee osteoarthritis (KOA), but the evidence is contradictory. Therefore, we carefully designed a...
BACKGROUND
Acupuncture has been used to relieve chronic pain in patients with knee osteoarthritis (KOA), but the evidence is contradictory. Therefore, we carefully designed a double-dummy randomized controlled trial (RCT) to explore the therapeutic effect of acupuncture for KOA.
METHODS/DESIGN
A total of 138 eligible participants with KOA who consent to participate will be randomly divided into Groups A, B, and C in a ratio of 1:1:1. Participants in Group A will receive verum acupuncture and placebo gel, while those in Groups B and C will be treated with diclofenac diethylammon gel and sham acupuncture, sham acupuncture and placebo gel, respectively. The patients will receive 4 weeks of treatment, five times a week, including acupuncture treatment once a day for 30 min and gel treatment three times a day. The primary outcome will be the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes will include visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline, week 4, 8, and 12 after randomization.
DISCUSSION
This double-dummy RCT used diclofenac diethylammon gel as a positive control, and the completion of this trial will provide detailed and accurate evidence of the efficacy and safety of acupuncture for KOA.
TRIAL REGISTRATION
China Clinical Trials Registry No.ChiCTR2100043947. Registered on September 24, 2020. https://www.chictr.org.cn/showproj.html?proj=122536 .
Topics: Humans; Osteoarthritis, Knee; Diclofenac; Acupuncture Therapy; Research Design; China; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 37848962
DOI: 10.1186/s13018-023-04198-2 -
Cureus Oct 2023Background Low back pain (LBP) is a global health concern. Management of LBP aims at pain relief facilitating improvement of functional ability. Non-steroidal...
Background Low back pain (LBP) is a global health concern. Management of LBP aims at pain relief facilitating improvement of functional ability. Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line of therapy. However, the selection of NSAIDs is challenging given the range of underlying etiologies and severity. The current study aimed to compare the efficacy and safety of two available fixed-dose combinations (FDCs), namely, a dual FDC (DFC) of etoricoxib (60 mg) and thiocolchicoside (4 mg) versus a triple FDC (TFC) of chlorzoxazone (500 mg), diclofenac (50 mg), and paracetamol (325 mg). Methodology A total of 200 eligible adult subjects aged 18-70 years with a history of LBP and muscle spasm for ≤14 days and Wong-Baker Faces Pain score >4 were enrolled after obtaining written informed consent and randomized in a 1:1 allocation ratio to be treated with either DFC or TFC for 28 days. Efficacy was assessed based on the change in score from baseline (before treatment) to day 28 on the Wong-Baker Faces Pain Scale and the Oswestry Disability Index (ODI) questionnaire, as well as the proportion of subjects who improved upon treatment. Safety was assessed based on adverse events and clinical laboratory test results. Results A significant decrease in pain intensity (p < 0.001) and significant improvement in functional ability (p < 0.001) was observed after treatment with either DFC or TFC. The decrease in Wong-Baker Faces Pain score and ODI, from baseline, was comparable between the treatment groups. However, more subjects with very severe pain at baseline showed ≥30% improvement upon treatment with DFC than with TFC (~25% versus ~12%; p = 0.172). Also, significantly more crippled subjects with very severe functional disability showed improvement in the DFC group compared to the TFC group (~26% versus ~4%; p = 0.008). No adverse events or clinically relevant laboratory test results were evident. Conclusions Both DFC and TFC were comparable in efficacy and safety for the management of recent-onset LBP. However, significantly more subjects with very severe pain or functional disability showed improvement after 28 days when treated with DFC compared to TFC.
PubMed: 38021944
DOI: 10.7759/cureus.47621 -
Annals of Medicine Dec 2024Tension-type headache is the most common type of primary headache and results in a huge socioeconomic burden. This network meta-analysis (NMA) aimed to compare the... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Tension-type headache is the most common type of primary headache and results in a huge socioeconomic burden. This network meta-analysis (NMA) aimed to compare the efficacy and safety of simple analgesics for the treatment of episodic tension-type headache (ETTH) in adults.
METHODS
We searched the Cochrane Library, PubMed, Web of Science, Embase, Chinese BioMedical Literature database and International Clinical Trials Registry Platform databases for eligible randomized clinical trials reporting the efficacy and/or safety of simple analgesics. A Bayesian NMA was performed to compare relative efficacy and safety. The surface under the cumulative ranking curve (SUCRA) was calculated to rank interventions. PROSPERO registration number: CRD42018090554.
RESULTS
We highlighted six studies including 3507 patients. For the 2 h pain-free rate, the SUCRA ranking was ibuprofen > diclofenac-K > ketoprofen > acetaminophen > naproxen > placebo. All drugs except naproxen reported a higher 2 h pain-free rate than placebo, with a risk ratio (RR) of 2.86 (95% credible interval, CrI: 1.62-5.42) for ibuprofen and 2.61 (1.53-4.88) for diclofenac-K. For adverse events rate, the SUCRA ranking was: metamizol > diclofenac-K > ibuprofen > lumiracoxib > placebo > aspirin > acetaminophen > naproxen > ketoprofen. The adverse event rates of all analgesics were no higher than those of placebo, except for ketoprofen. Moreover, all drugs were superior to placebo in the global assessment of efficacy. In particular, the RR of lumiracoxib was 2.47 (1.57-4.57). Global heterogeneity between the studies was low.
CONCLUSIONS
Simple analgesics are considered more effective and safe as a placebo for ETTH in adults. Our results suggest that ibuprofen and diclofenac-K may be the two best treatment options for patients with ETTH from a comprehensive point of view (both high-quality evidence).
Topics: Humans; Tension-Type Headache; Analgesics; Adult; Network Meta-Analysis; Ibuprofen; Acetaminophen; Bayes Theorem; Treatment Outcome; Diclofenac; Randomized Controlled Trials as Topic; Naproxen; Ketoprofen; Anti-Inflammatory Agents, Non-Steroidal; Female; Male
PubMed: 38813682
DOI: 10.1080/07853890.2024.2357235 -
BMC Pediatrics Aug 2023Children in acute pain often receive inadequate pain relief, partly from difficulties administering injectable analgesics. A rapid-acting, intranasal (IN) analgesic may... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Children in acute pain often receive inadequate pain relief, partly from difficulties administering injectable analgesics. A rapid-acting, intranasal (IN) analgesic may be an alternative to other parenteral routes of administration. Our review compares the efficacy, safety, and acceptability of intranasal analgesia to intravenous (IV) and intramuscular (IM) administration; and to compare different intranasal agents.
METHODS
We searched Cochrane Library, MEDLINE/PubMed, Embase, Web of Knowledge, Clinicaltrials.gov, Controlled-trials.com/mrcr, Clinicaltrialsregister.eu, Apps.who.int/trialsearch. We also screened reference lists of included trials and relevant systematic reviews. Studies in English from any year were included. Two authors independently assessed all studies. We included randomised trials (RCTs) of children 0-16, with moderate to severe pain; comparing intranasal analgesia to intravenous or intramuscular analgesia, or to other intranasal agents. We excluded studies of procedural sedation or analgesia. We extracted study characteristics and outcome data and assessed risk of bias with the ROB 2.0-tool. We conducted meta-analysis and narrative review, evaluating the certainty of evidence using GRADE. Outcomes included pain reduction, adverse events, acceptability, rescue medication, ease of and time to administration.
RESULTS
We included 12 RCTs with a total of 1163 children aged 3 to 20, most below 10 years old, with a variety of conditions. Our review shows that: - There may be little or no difference in pain relief (single dose IN vs IV fentanyl MD 4 mm, 95% CI -8 to 16 at 30 min by 100 mm VAS; multiple doses IN vs IV fentanyl MD 0, 95%CI -0.35 to 0.35 at 15 min by Hannallah score; single dose IN vs IV ketorolac MD 0.8, 95% CI -0.4 to 1.9 by Faces Pain Scale-Revised), adverse events (single dose IN vs IV fentanyl RR 3.09, 95% CI 0.34 to 28.28; multiple doses IN vs IV fentanyl RR 1.50, 95%CI 0.29 to 7.81); single dose IN vs IV ketorolac RR 0.716, 95% CI 0.23 to 2.26), or acceptability (single dose IN vs IV ketorolac RR 0.83, 95% CI 0.66 to 1.04) between intranasal and intravenous analgesia (low certainty evidence). - Intranasal diamorphine or fentanyl probably give similar pain relief to intramuscular morphine (narrative review), and are probably more acceptable (RR 1.60, 95% CI 1.42 to 1.81) and tolerated better (RR 0.061, 95% CI 0.03 to 0.13 for uncooperative/negative reaction) (moderate certainty); adverse events may be similar (narrative review) (low certainty). - Intranasal ketamine gives similar pain relief to intranasal fentanyl (SMD 0.05, 95% CI -0.20 to 0.29 at 30 min), while having a higher risk of light sedation (RR 1.74, 95% CI 1.30 to 2.35) and mild side effects (RR 2.16, 95% CI 1.72 to 2.71) (high certainty). Need for rescue analgesia is probably similar (RR 0.85, 95% CI 0.62 to 1.17) (moderate certainty), and acceptability may be similar (RR 1.15, 95% CI 0.89 to 1.48) (low certainty).
CONCLUSIONS
Our review suggests that intranasal analgesics are probably a good alternative to intramuscular analgesics in children with acute moderate to severe pain; and may be an alternative to intravenous administration. Intranasal ketamine gives similar pain relief to fentanyl, but causes more sedation, which should inform the choice of intranasal agent.
Topics: Child; Humans; Ketorolac; Ketamine; Pain; Analgesia; Fentanyl
PubMed: 37596559
DOI: 10.1186/s12887-023-04203-x -
ACS Omega Feb 2024Curcumin (CUR) is a natural product with known anti-inflammatory, antioxidant, and hepatoprotective properties. The aim of this study was to formulate CUR into a...
Curcumin (CUR) is a natural product with known anti-inflammatory, antioxidant, and hepatoprotective properties. The aim of this study was to formulate CUR into a polymeric nanoparticle (NP) formulation and examine its potential hepatoprotective activity in an animal model of diclofenac (DIC)-induced hepatotoxicity. CUR was loaded into polymeric NPs composed of poly(ethylene glycol)-polycaprolactone (PEG-PCL). The optimal CUR NPs were evaluated against DIC-induced hepatotoxicity in mice, by studying the histopathological changes and gene expression of drug-metabolizing ( and ) and () genes in the livers of the animals. The optimal NPs were around 67 nm in diameter with more than 80% loading efficiency and sustained release. Histological findings of mice livers revealed that CUR NPs exhibited a superior hepatoprotective effect compared to free CUR, and both groups reduced DIC-mediated liver tissue injury. While treatment with DIC alone or with CUR and CUR NPs had no effect on gene expression, and genes were upregulated in the DIC-treated group, and this effect was reversed by CUR both as a free drug and as CUR NPs. Our findings present a promising application for nanoencapsulated CUR in the treatment of nonsteroidal anti-inflammatory drugs-induced liver injury and the associated dysregulation in the expression of hepatic drug-metabolizing enzymes.
PubMed: 38405487
DOI: 10.1021/acsomega.3c07602 -
The Journal of Physical Chemistry. B Jan 2024Environmental pollution by man-made toxic and persistent organic compounds, found throughout the world in surface and groundwater, has various negative effects on...
Environmental pollution by man-made toxic and persistent organic compounds, found throughout the world in surface and groundwater, has various negative effects on aquatic life systems and even humans. Therefore, it is important to develop and improve water treatment technologies capable of removing such substances from wastewater and purifying drinking water. The two substances investigated are the widely used painkiller diclofenac and a member of the class of "forever chemicals", perfluorobutanesulfonate. Both are known to have serious negative effects on living organisms, especially under long-term exposure, and are detectable in human hair, suggesting adsorption to a part of the hair fiber complex. In this study, a human hair keratin dimer is investigated for its ability to absorb diclofenac and perfluorobutanesulfonate. Initial predictions for binding sites are obtained via molecular docking and subjected to molecular dynamics simulations for more than 1 μs. The binding affinities obtained by the linear interaction energy method are high enough to motivate further research on human hair keratins as a sustainable, low-cost, and easily allocatable filtration material.
Topics: Humans; Diclofenac; Keratins, Hair-Specific; Adsorption; Molecular Docking Simulation; Hair; Fluorocarbons; Sulfonic Acids
PubMed: 38154791
DOI: 10.1021/acs.jpcb.3c04997 -
Korean Journal of Anesthesiology Dec 2023Cesarean section is associated with moderate to severe pain and nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly employed. The optimal NSAID, however, has not... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cesarean section is associated with moderate to severe pain and nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly employed. The optimal NSAID, however, has not been elucidated. In this network meta-analysis and systematic review, we compared the influence of control and individual NSAIDs on the indices of analgesia, side effects, and quality of recovery.
METHODS
CDSR, CINAHL, CRCT, Embase, LILACS, PubMed, and Web of Science were searched for randomized controlled trials comparing a specific NSAID to either control or another NSAID in elective or emergency cesarean section under general or neuraxial anesthesia. Network plots and league tables were constructed, and the quality of evidence was evaluated with Grading of Recommendations Assessment, Development and Evaluation (GRADE) analysis.
RESULTS
We included 47 trials. Cumulative intravenous morphine equivalent consumption at 24 h, the primary outcome, was examined in 1,228 patients and 18 trials, and control was found to be inferior to diclofenac, indomethacin, ketorolac, and tenoxicam (very low quality evidence owing to serious limitations, imprecision, and publication bias). Indomethacin was superior to celecoxib for pain score at rest at 8-12 h and celecoxib + parecoxib, diclofenac, and ketorolac for pain score on movement at 48 h. In regard to the need for and time to rescue analgesia COX-2 inhibitors such as celecoxib were inferior to other NSAIDs.
CONCLUSIONS
Our review suggests the presence of minimal differences among the NSAIDs studied. Nonselective NSAIDs may be more effective than selective NSAIDs, and some NSAIDs such as indomethacin might be preferable to other NSAIDs.
Topics: Humans; Pregnancy; Female; Diclofenac; Ketorolac; Celecoxib; Cesarean Section; Network Meta-Analysis; Anti-Inflammatory Agents, Non-Steroidal; Indomethacin; Pain
PubMed: 37066603
DOI: 10.4097/kja.23014 -
Frontiers in Pediatrics 2023Postoperative nausea and vomiting (PONV) is an unpleasant complication after surgery that commonly co-occurs with pain. Considering the high prevalence among pediatric...
BACKGROUND
Postoperative nausea and vomiting (PONV) is an unpleasant complication after surgery that commonly co-occurs with pain. Considering the high prevalence among pediatric patients, it is important to explore the main risk factors leading to PONV in order to optimize treatment strategies. The objectives of this study are as follows: (1) to determine the prevalence of PONV on the day of surgery by conducting interviews with pediatric patients, (2) to assess PONV prevalence in the recovery room and on the ward by analyzing nursing records, and (3) to collect information on PONV risk factors on the day of surgery and the following postoperative days. We wanted to investigate real-life scenarios rather than relying on artificially designed studies.
METHODS
A prospective analysis [according to STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines] of PONV on the day of surgery and the following postoperative days was conducted by evaluating demographic and procedural parameters, as well as conducting interviews with the children under study. A total of 626 children and adolescents, ranging in age from 4 to 18 years, were interviewed on the ward following their surgery. The interviews were conducted using a questionnaire, as children aged 4 and above can participate in an outcome-based survey.
RESULTS
On the day of surgery, several multivariable independent predictors were identified for PONV. The type of surgery was found to be a significant factor ( = 0.040) with the highest odds ratio (OR) in patients with procedural investigations [OR 5.9, 95% confidence interval (CI): 1.8-19.2], followed by abdominal surgery (OR 3.1, 95% CI: 0.9-11.1) when inguinal surgery was used as the reference category. In addition, the study identified several predictors, including the amount of fentanyl administered during anesthesia (µg/kg body weight) (OR 1.4, 95% CI: 1.1-1.8), intraoperative use of piritramide (OR 2.6, 95% CI: 1.5-4.4) and diclofenac (OR 2.0, 95% CI: 1. 3-3.1), opioid administration in the recovery room (OR 3.0, 95% CI: 1.9-4.7), and piritramide use on the ward (OR 4.5, 95% CI: 1.7-11.6).
CONCLUSIONS
The main risk factors for PONV include the intraoperative administration of opioids during the recovery room stay and at the ward, the intraoperative use of non-opioids (diclofenac), and the specific type of surgical procedure. Real-life data demonstrated that in clinical praxis, there is a gap between the adherence to established guidelines and the use of antiemetic prophylaxis in surgeries that are generally not associated with a high PONV prevalence. Further efforts are needed to improve the existing procedures and thus improve the overall outcome.
PubMed: 37964809
DOI: 10.3389/fped.2023.1241304 -
European Endodontic Journal Apr 2024To compare the effect of pre-treatment transdermal and oral diclofenac on post-endodontic pain level and oral health-related quality of life (OHRQOL) in patients with...
OBJECTIVE
To compare the effect of pre-treatment transdermal and oral diclofenac on post-endodontic pain level and oral health-related quality of life (OHRQOL) in patients with symptomatic irreversible pulpitis with apical periodontitis in mandibular molars following single visit root canal treatment.
METHODS
This parallel-arm, randomised, double-blinded clinical trial is reported according to the Consoli-dated Standards of Reporting Trials (CONSORT) 2020 guidelines. The protocol was approved by the Institu-tional Ethical Committee on 30th March 2021 (MADC/IEC-I/029/2021) and registered at the clinical trial reg-istry of India (CTRI/2021/12/038696). Adult patients fulfilling the eligibility criteria were randomised into two groups. Group DTP received a diclofenac transdermal patch 100 mg, and Group DOT received a diclofenac oral tablet 100 mg one hour before root canal treatment. Pain scores were checked at baseline, 2, 4, 6, 8, 24, 48, and 72 hours after the treatment. OHRQOL was assessed at baseline and one week after the treatment.
RESULTS
Both groups were associated with a significantly lower incidence of post-operative pain and im-proved OHRQOL. At 2 hours, the pain level was significantly lower with an oral diclofenac tablet, and at 24 hours, the pain level was significantly lower with a diclofenac transdermal patch. Regarding OHRQOL, there was no significant difference between the two groups.
CONCLUSION
Within the limitations of this study, the diclofenac transdermal patch had lesser post-operative pain at 24 hours, whereas the oral diclofenac tablet had lesser pain at 2 hours.
PubMed: 38619496
DOI: 10.14744/eej.2024.37233