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Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial.
Raj, JP, Venkatachalam, S, Racha, P, Bhaskaran, S, Amaravati, RS
Complementary therapies in medicine. 2020;:102522
Abstract
OBJECTIVE Curcuma longa has been widely used in Ayurveda for its medicinal properties and Turmacin was developed from C. longa as a standardized extract containing turmerosaccharides. In this clinical trial, the effect of Turmacin on knee joint discomfort in healthy adults subjected to strenuous physical activity was evaluated. DESIGN Double-blind, triple-arm, parallel-group, randomized placebo-controlled trial. SETTING Healthy participants from an urban tertiary care teaching hospital. INTERVENTION Healthy participants were randomized in 1:1:1 ratio to receive either Turmacin 0.5 g/1 g or placebo once daily for 84 days. The participants were subjected to 10-minute strenuous exercise. OUTCOME MEASURES Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint. RESULTS A total of n = 90 participants were recruited. The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively. The survival analysis consistently showed a decreased hazard for early onset of pain in both the Turmacin groups. On day-84, the difference in mean ROM between Turmacin 0.5 g and placebo was 4.79 degrees (p = 0.008) and that for Turmacin 1 g and placebo was 2.34 degrees (p = 0.306). The difference in muscle force for isokinetic contractions of the quadriceps at angular velocities of 120 and 180 was significant between Turmacin 0.5 g and placebo (p = 0.002 and p = 0.005 respectively) while that for Turmacin 1 g & Turmacin 0.5 g (p = 0.206 and p = 0.414 respectively) and Turmacin 1 g & Placebo (p = 0.046 and p = 0.037) were not significant. However, in the within group analysis participants in Turmacin 1 g group had better preserved muscle functions than Turmacin 0.5 g group at angular velocities of 120 and 180 when compared with placebo. CONCLUSION Turmacin (0.5 g and 1 g) was efficacious when compared to placebo in increasing the pain threshold and knee ROM in healthy participants with minor adverse events.
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Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.
Besirli, CG, Smith, SJ, Zacks, DN, Gardner, TW, Pipe, KP, Musch, DC, Shah, AR
Ophthalmology. Retina. 2020;(10):979-986
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Abstract
PURPOSE To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections. DESIGN Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012). PARTICIPANTS Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included. METHODS A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT. MAIN OUTCOME MEASURES We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC. RESULTS A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001). CONCLUSIONS Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.
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Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.
Tsaousi, G, Nikopoulou, A, Pezikoglou, I, Birba, V, Grosomanidis, V
Clinical neurology and neurosurgery. 2020;:106091
Abstract
OBJECTIVE To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery. METHODS Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points. RESULTS Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded. CONCLUSION It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.
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Unrecognized challenges of treating status migrainosus: An observational study.
Iljazi, A, Chua, A, Rich-Fiondella, R, Veronesi, M, Melo-Carrillo, A, Ashina, S, Burstein, R, Grosberg, B
Cephalalgia : an international journal of headache. 2020;(8):818-827
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BACKGROUND Status migrainosus is a condition with limited epidemiological knowledge, and no evidence-based treatment guideline or rational-driven assessment of successful treatment outcome. To fill this gap, we performed a prospective observational study in which we documented effectiveness of treatment approaches commonly used in a tertiary headache clinic. MATERIAL AND METHODS Patients with episodic and chronic migraine who experienced continuous and prolonged attacks for more than 72 hours were treated with dexamethasone (4 mg orally twice daily for 3 days), ketorolac (60 mg intramuscularly), bilateral nerve blocks (1-2% lidocaine, 0.1-0.2 ml for both supraorbital and supratrochlear nerves, 1 ml for both auriculotemporal nerves, and 1 ml for both greater occipital nerves), or naratriptan (2.5 mg twice daily for 5 days). Hourly (for the first 24 hours) and daily (for first 30 days) change in headache intensity was documented using appropriate headache diaries. RESULTS Fifty-four patients provided eligible data for 60 treatment attempts. The success rate of rendering patients pain free within 24 hours and maintaining the pain-free status for 48 hours was 4/13 (31%) for dexamethasone, 7/29 (24%) for nerve blocks, 1/9 (11%) for ketorolac and 1/9 (11%) for naratriptan. These success rates depended on time to remission, as the longer we allowed the treatments to begin to work and patients to become pain free (i.e. 2, 12, 24, 48, 72, or 96 hours), the more likely patients were to achieve and maintain a pain-free status for at least 48 hours. DISCUSSION These findings suggest that current treatment approaches to terminating status migrainosus are not satisfactory and call attention to the need to develop a more scientific approach to define a treatment response for status migrainosus.
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Hydration may reverse most symptoms of lower extremity intermittent claudication or rest pain.
Parodi, JC, Fernandez, S, Moscovich, F, Pulmaria, C
Journal of vascular surgery. 2020;(4):1459-1463
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BACKGROUND Medical treatment of severe intermittent claudication or critical limb-threatening ischemia causing rest pain frequently achieves only partial relief or is not effective at all. METHODS Patients with severe intermittent claudication or rest pain of the lower extremities who did not improve after control of risk factors, supervised exercises, and cilostazol medication were included in this study. All patients were treated with hydration. They were asked to drink 2500 mL of fluids (water, soup, milk) during a 24-hour period and to ingest 0.6 g/kg of albumin a day, as egg white or albumin powder. Total salt administered daily was 3.5 g. Symptoms, skin temperature, ankle-brachial index, albumin concentration in serum, and time and distance to claudication were recorded before treatment, at 6 weeks, and at 6 months. Electrolytes were measured monthly. No additional treatment was used during the study. Walking was encouraged but not supervised. The trial has continued indefinitely. For statistical analysis, SPSS software (IBM Corp, Armonk, NY) was used. The Ethical Committee approved the protocol, and an informed consent was signed by all patients. RESULTS There were 132 patients (94 male, 38 female) included in the study. Median age was 72.5 years (range, 67-77 years); all had severe claudication of a mean of 100 meters or rest pain. Symptoms had been present for >5 months in all patients; 22 (16.8%) had rest pain. Proper hydration, determined as drinking at least 2000 mL of water during 24 hours for a period of 6 months, was achieved in 131 compliant patients. Only one patient failed to drink 2000 mL of water or more. Ankle-brachial index in 131 compliant patients improved from 0.6 to 0.75 (P < .0001) after 6 months. Skin temperature of the feet increased from 29.4°C to 31.7°C (P = .009). Distance to claudication using the treadmill improved from 100 meters to 535 meters (P < .0001) at 6 weeks and remained stable at 6 month in 65.83% of the patients; in 34.17% of them, distance to claudication increased further by 200 (100-500) meters and time to claudication improved from 1.3 to 6.3 minutes (P < .0001) at 6 weeks, but the same group of patients (34.17%) that increased the distance to claudication further prolonged the time to claudication by 2.49 (1.24-6.23) minutes. All 131 compliant patients improved their status related to lower extremity ischemia; the noncompliant patient did not have any variation of symptoms, skin temperature, ankle-brachial index, or time and distance to claudication. All patients survived the initial 6 months of treatment; afterward, three patients abandoned the treatment and four died of unrelated causes. After the 6-month control, 49% of the patients continued to improve the time and distance to claudication as well as the ankle-brachial index. The rest of the patients conserved the initial improvement. Five patients who had significantly improved the time and distance to claudication were asked to decrease water intake for 3 days. No changes in time and distance to claudication were detected. Hydration was reinitiated. CONCLUSIONS This study suggests that proper hydration by drinking ≥2000 mL of water daily and albumin complement orally to reach 4 g/dL in serum could be included in the armamentarium of physicians treating patients with disabling claudication or rest pain caused by peripheral artery disease. Further comparative studies to assess the benefit of hydration and increasing the serum oncotic pressure are warranted.
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When ESKD complicates the management of pain.
Jhamb, M, Tucker, L, Liebschutz, J
Seminars in dialysis. 2020;(3):286-296
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Pain is one of the most common symptoms reported by patients with end-stage kidney disease (ESKD) and negatively impacts their health-related quality of life (HRQOL), dialysis adherence, healthcare utilization, and mortality. There are a number of patient-related and health system-related barriers that make it very challenging to treat pain in these patients. Moreover, the limited availability of efficacious and safe nonopiate analgesic options has led to over-use of opioids in this population. We propose a framework for pain assessment and tailored treatment using nonpharmacological and pharmacological approaches to optimize pain management and opioid use. Additionally, we recommend system-level changes to improve care coordination and pain management in ESKD patients.
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The Efficacy of Topical Basil Essential Oil on Relieving Migraine Headaches: A Randomized Triple-Blind Study.
Ahmadifard, M, Yarahmadi, S, Ardalan, A, Ebrahimzadeh, F, Bahrami, P, Sheikhi, E
Complementary medicine research. 2020;(5):310-318
Abstract
OBJECTIVE Complementary therapies have been increasingly used for the prevention and treatment of migraine so that there is a need for studies in this setting. This study sought to determine the effects of basil essential oil on the severity and frequency of migraine attack headaches. METHODS A triple-blind clinical trial study was performed on 144 patients diagnosed with migraine. Patients were randomly allocated by a stratified method to four groups of 36 titled basil essential oil 2, 4, 6%, and placebo groups. Medications were used topically every 8 h for 3 successive months. In addition, each individual received 325 mg of acetaminophen every 12 h. The severity and frequency of migraine attacks were measured prior to the study, at weeks 2, 4, 8, and 12. The visual analog scale was used to measure pain intensity. The marginal model and generalized estimation equations were used to compare changes in the intensity and frequency of pain over time. RESULTS The interaction of the dose and time factors was significant on both pain intensity (p < 0.001) and frequency of attack (p < 0.001). The odds ratio of higher pain intensity and rate ratio of higher frequency of attack in the intervention groups compared to the placebo group were decreased over the study time. CONCLUSION Time lapse and higher doses of basil essential oil would reduce both the intensity and frequency of migraine attacks.
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Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial.
Nazemian, N, Torabi, M, Mirzaee, M
The American journal of emergency medicine. 2020;(8):1635-1640
Abstract
OBJECTIVES Renal colic is one of the most common painful disorders in patients referred to the emergency department. The main purpose of this study was to compare the efficiency of two methods of intravenous (IVF) and intranasal (INF) fentanyl administration in pain management in patients with severe renal colic. MATERIALS & METHODS This was a single-blind randomized clinical trial performed on patients with severe renal colic. The severity of pain was ≥8 based on the Numerical Rating Scale (NRS). The efficacy of pain management was compared within and between the IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl) groups at different times points. Oral consent was obtained from all the patients. RESULTS Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men. There were no significant differences between the two groups regarding the baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI). The pain severity showed a significant reducing trend in both groups (p < 0.0001). There was also a significant difference comparing the mean pain severity between groups at different times (p < 0.0001). In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001). CONCLUSION Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients.
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The Role of Exparel Plus Meloxicam for Postoperative Pain Management.
Kaye, AD, Novitch, MB, Carlson, SF, Fuller, MC, White, SW, Haroldson, AR, Kaiser, JA, Elkersh, MA, Brunk, AJ, Jeha, GM, et al
Current pain and headache reports. 2020;(3):6
Abstract
PURPOSE OF REVIEW Acute postoperative pain reduction is a major target against the opioid crisis. While opioids have traditionally been the mainstay for postoperative analgesia, current practice has focused on a multimodal approach to pain control, including ultrasound-guided blocks with longer acting local anesthetic agents. RECENT FINDINGS Non-steroidal anti-inflammatory drugs (NSAIDs), such as meloxicam, are an important class of medications utilized to manage pain in the perioperative period. An additional treatment used in perioperative or postoperative pain relief is Exparel, a bupivacaine (sodium channel blocker) liposomal injectable suspension with a 3-4-day duration of action. The long-acting mechanism and formulation of Exparel consistently has demonstrated decreased opioid use and pain scores in patients undergoing many different surgical procedures. A concern is that pH negatively alters the efficacy of bupivacaine, as in cases of inflamed tissue and acidic fluid pH. For this reason, a combination medication with both meloxicam and bupivacaine has been developed, which normalizes pH and has anti-inflammatory and anti-pain conduction properties. Clinical studies demonstrate that this combination agent can be extremely beneficial in treating postoperative pain. This manuscript summarizes the newest developments with regard to liposomal bupivacaine and the non-steroidal meloxicam, their roles in effective treatment of postoperative pain, contraindications, special considerations of using these medications, and future considerations. HTX-011 pairs up a new extended-release formulation of the local anesthetic bupivacaine with meloxicam, a well-established non-steroidal anti-inflammatory drug (NSAID).
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Nutritional factors in chronic musculoskeletal pain: unravelling the underlying mechanisms.
Elma, Ö, Yilmaz, ST, Deliens, T, Coppieters, I, Clarys, P, Nijs, J, Malfliet, A
British journal of anaesthesia. 2020;(2):e231-e233