compound topical anesthetic

0000013954 00000 n 0000012140 00000 n https://www.arthritis.org/living-with-arthritis/treatments/medication/drug-types/nsaids/voltaren-gel-relief.php. Council on Clinical Affairs, American Academy of Pediatric Dentistry. Compounding for Warts and Fungal Infections, At-home hair regrowth therapy as a maintenance treatment. b:mhd. 0000013667 00000 n 2020 Spring;67(1):9-15. doi: 10.2344/anpr-66-03-05. 0000091925 00000 n Some studies have shown that over-the-counter products result in higher serum concentrations of lidocaine compared to prescription compounded products with lidocaine. Reznik DS, Jeske AH, Chen JW, English J. 15 Compared to other types of dental topical anesthetics, compounded agents are typically more potent due to high drug concentrations, which means they may offer longer duration times. lar dermal compounded topical anesthetic.7 Profound is a topical anesthetic gel compounded from three anesthetic agents (10% lidocaine, 10% prilocaine, and 4% tetracaine). In the 2013 FDA's Adverse Events Reporting system, it identified a total of 375 cases of methemoglobinemia associated with benzocaine.31 Methemoglobinemia results from oxidation of iron, causing its inability to effectively bind and carry oxygen, which may result in anemia and hypoxia.17 Taleb32 stated that benzocaine accounted for 66% of the total cases of methemoglobinemia compared with lidocaine (5%) and prilocaine (28%) in adults undergoing transesophageal echocardiography. Opinions differ on the effectiveness of over-the-counter topical pain medications. https://www.micromedexsolutions.com. More methemoglobin is produced by benzocaine treatment that lidocaine treatment in human in vitro systems. To provide you with the most relevant and helpful information, and understand which The neuropathic pain group used cream containing ketamine, gabapentin, clonidine and lidocaine. The compounded creams and gels generally contain one or more prescription or other anesthetic, analgesic, sedative, antidepressant, anti-seizure or muscle relaxant drugs that are used to treat pain. Evaluation and management of acquired methemoglobinemia associated with topical benzocaine use. A 10% lidocaine numbing cream may be used before skin procedures like laser treatments, injections, microneedling, and more. In the case of dental work, compounded topical anesthetics are used to keep patients comfortable and ensure they do not have pain during procedures. There were slight differences between groups with regards to race, with the proportion of white subjects in the experimental group being 26.6 versus 40.0% in the control group. By recognizing that people respond differently to the same treatments, it is possible to tailor medical doses, practices, and interventions. The Figure shows the median heart rate in beats per minute for each group at each time point as measured by the pulse oximeter. A risk-benefit assessment of topical percutaneous local anaesthetics in children. The development of novel HF treatments requires the testing of potential therapeutic procedures in appropriate animal models of HF. 2021 Jul 1;21(1):327. doi: 10.1186/s12903-021-01691-0. is important to the age/sex group still circulating estrogen. Review/update the For the neuropathic pain group, there was a 0.1-point difference between the drug group (-1.4) and the placebo group (-1.3). Some compounding pharmacies bypass the new FDA drug approval process, which is based on reliable scientific data and ensures that a marketed drug is safe, effective, properly manufactured and accurately labeled. Abstract. Demographics and Clinical Characteristics of the Study Population. 0000102308 00000 n Similarly, the Medicare Part D program paid out more than half a billion dollars for the creams in 2015. Off-Label Uses: Compounded topical lidocaine and prilocaine preparations have not been shown to be superior to commercially available topical lidocaine and prilocaine preparations. Results: The higher strength numbing creams provide a more potent anesthesia that can improve the patient experience, especially for skin and cosmetic procedures performed in dermatology offices. 2023 Feb 24;10(3):444. doi: 10.3390/children10030444. Compound topical anesthetics are neither FDA-regulated nor -unregulated. This project was supported by grants UL1TR001855 and UL1TR000130 from the National Center for Advancing Translational Science (NCATS) of the US National Institutes of Health. The oral mucosa adjacent to the maxillary right canine was dried with 2 2 gauze. %PDF-1.4 % No benefits were seen with the use of 10% lidocaine, 10% prilocaine, and 4% tetracaine as a topical. Application of capsaicin creams can make your skin burn or sting, but this discomfort generally lessens within a few weeks of daily use. The compounded creams and gels generally contain one or more prescription or other anesthetic, analgesic, sedative, antidepressant, anti-seizure or muscle relaxant drugs that are used to treat pain. We offer practical recommendations for their use. The author reviewed the history of, federal regulations regarding, risks of and adverse drug reactions of five compound topical anesthetics: tetracaine, adrenaline/epinephrine and cocaine (TAC); lidocaine, adrenaline/epinephrine and tetracaine (LET); lidocaine, tetracaine and phenylephrine (TAC 20 percent Alternate); lidocaine, prilocaine and tetracaine (Profound); and lidocaine, prilocaine, tetracaine and phenylephrine with thickeners (Profound PET). information highlighted below and resubmit the form. Kumar M, Chawla R, Goyal M. Topical anesthesia. Methemoglobinemia associated with topical benzocaine is rather rare, certainly in comparison with the benzocaine spray; however, the spray may have the highest incidence simply because it is the most commonly used formulation in preparation for ENT procedures, which is not so in dentistry.32 The spray may be more commonly associated with methemoglobinemia due to the difficulty in regulating dose/volume during administration, so it may be quite easy to overdose. In fact, only about 1% of reported allergies to local anesthetics are actually related to an immune response. None of the authors report a conflict of interest. This is especially important for topical anesthetics that are applied to the mouth, because your pharmacist can add flavoring to make the product taste good while it also numbs your mouth or gums. While many people say these products help relieve their arthritis pain, scientific research reveals only modest benefits. With the number of research participants studied as long as they were studied, we should have been able to see a statistically significant difference in pain reduction if these creams were actually working, says Cohen, senior author of the paper. Careers. Compound topical anesthetics are used for a variety of procedures including: Scaling and root planing Soft tissue and palatal procedures Pre-injection numbing Placement of orthodontic Temporary Anchorage Devices (TADs) Taking impressions and intra-oral radiographs %%EOF Increased AEs, like tissue sloughing, have not been reported in similar studies using lidocaine and prilocaine CTAs.16,17 The increase in tissue sloughing may be due to the tetracaine component of the CTA used in this study. Topical anesthetics such as lidocaine produce a numb sensation to reduce pain. Gender, ethnicity, and baseline heart rate were all included in the final model as these 3 factors were found to be significant predictors of VAS scores, though none were confounders of the association between treatment group and VAS scores. Friendly, knowledgeable staff! Click through below for comprehensive information on how we can support you in treating the following conditions. Comparison of topical anesthetics with lidocaine infiltration during laceration repair in children. sharing sensitive information, make sure youre on a federal The reported effects of CTAs in the literature have been inconsistent. If you had your prescription filled by Woodland Hills Pharmacy, you can have the same prescription filled with Park Compounding Pharmacy without any interruption in your treatment. To more fully assess compounding across pain mechanisms, the committee also examined an additional 10 ingredients that are commonly used in compounded topical pain creams: anesthetics (ketamine, bupivacaine, lidocaine) antiepileptic (carbamezepine) NSAID (naproxen) cannabinoid (cannabidiol) steroid (dexamethasone) This site needs JavaScript to work properly. Other researchers who participated in the study are Parvaneh Moussavian-Yousefi, Pharm.D. Although an allergic reaction is rare, lidocaine can cause adverse events when serum concentrations become excessively high. hbbd``b` $ < $gqDx 0 $B $^l- @$ W6Fj} 0 EZ Meng Z, et al. Woodland Hills Pharmacy is now Park Compounding Pharmacy. The inclusion criteria were as follows: ages 21 years and older, who were American Society of Anesthesiology (ASA) Type I, as defined by the ASA Physical Status Classification System.14 Exclusion criteria included the following: history of any known drug or food allergies, active oral lesions, open sores, or any recent surgery in the oral cavity. The vast majority of the volunteers were dental students and auxiliaries, which led to a homogenous sample size that caused a lack of generalizability in this study. Wu H, Hu Y, Shi XR, et al. In the United States, the Food and Drug Administration has approved several topical products (Voltaren, Solaraze, others) that contain the prescription NSAID diclofenac for the treatment of osteoarthritis in joints close to the skin's surface, such as the hands and knees. 0000015848 00000 n Mayo Clinic, Phoenix/Scottsdale, Ariz. June 14, 2019. Changes in heart rate between the 2 groups were not statistically or clinically significant. Barker W, Rodeheaver GT, Edgerton MT, Edlich RF. Koppolu P, Mishra A, Swapna LA, Butchibabu K, Bagalkokar A, Baroudi K. Comparison of efficacy among various topical anesthetics: an approach towards painless injections in periodontal surgery. 0000101053 00000 n J Am Board Fam Pract. A compound multivitamin designed for vegans can fill nutritional gaps. Tulga F, Mutlu Z. It provides one of the few instances where you get to hear the sigh of relief as a salve is rubbed in not something a pill or surgical intervention provides! endstream endobj startxref This pilot study was a randomized, prospective, double-blinded clinical trial, in which 2 different topical anesthetic groups were compared. hb```%_@(1\f :g)] Fi pU@~+bqy@w9`epv"i@ Alqareer A, Alyahya A, Andersson L. The effect of clove and benzocaine versus placebo as topical anesthetics. @HopkinsMedicine study reveals that there is no scientific evidence to prove that pain creams and gels significantly relieve sorness while healthcare costs for these meds total to $600 billion annually! Would you like email updates of new search results? Mayo Clinic offers appointments in Arizona, Florida and Minnesota and at Mayo Clinic Health System locations. They work by blocking nerve sensations which can be used as an effective way to stop or prevent pain. The https:// ensures that you are connecting to the Ferrazzano GF, Di Fabio G, Gatto R, Caruso S, Botticelli G, Caruso S. Children (Basel). 0000004385 00000 n Then the participants were divided into three equally numbered groups according to their history of chronic localized pain: neuropathic pain caused by disease or damage to the nerves, such as shingles or diabetes; nociceptive pain (non-neuropathic) caused by injury to tissue, such as burns or sprains; and so-called mixed pain caused by damage to the nerves and tissues, such as certain types of back pain. Vaccines & Boosters | Testing | Visitor Guidelines | Coronavirus, Compounded topical pain creams and gels work about as well as placebos, study shows, Study shows no scientifically significant statistical difference between relief offered by these creams and placebos Rosa AL, Sverzut CE, Xavier SP, Lavrador MA. Effect on VAS by Study Group Assignment (n = 52). The very products used can be tuned to the individual patient based on their predicted response or risk of disease. The .gov means its official. These AEs were documented and followed until it had resolved. Efficacy of benzocaine 20% topical anesthetic compared to placebo prior to administration of local anesthesia in the oral cavity: a randomized controlled trial. Topical anesthetics reversibly block nerve conduction near their site of administration, thereby producing temporary loss of sensation in a limited area. Excellent experience! An a priori power analysis was performed to calculate the sample size needed for the primary dependent variable, the evaluation of pain using visual analog scale (VAS) scores. All compounded lidocaine 10% creams made by our pharmacy require a prescription. Wiswall AT, Bowles WR, Lunos S, McClanahan SB, Harris S. Palatal anesthesia: comparison of four techniques for decreasing injection discomfort. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. The very products used can be tuned to the individual patient based on their predicted response or risk of disease. They can be used to numb any area of the skin as well as the front of the eyeball, the inside of the nose, ear or throat, the anus and the genital area. While patients may report allergies to local anesthetics, in the majority of cases the reactions are not immune-mediated. All subjects in both groups were ASA 1, as specified in the inclusion criteria. Wash your hands thoroughly after each application and avoid touching your eyes and mucous membranes. All the participants were patients at military treatment facilities and were eligible to use TRICARE outside the military treatment facilities. It is a task we relish: We are not pharmacists because it is easy; we are here because its worthwhile. The research involved 399 participants ages 1890. 0000099800 00000 n Both types of topical anesthetic showed similar impacts on alterations to heart rate. Cohen says that all participants improved slightly throughout the study, affirming the long-recognized placebo effect, which is generally stronger for pain treatment than for other medical disorder therapies. 0000102371 00000 n Reznik et al18 found that a CTA containing lidocaine 20%, tetracaine 4%, and phenylephrine 2% was more effective than 20% benzocaine in pain reduction during placement of orthodontic temporary anchorage devices. Since the study was randomized, confounders that required adjustment were not expected. Major LAST events are reported up to 1.8/1000 peripheral nerve blocks. BMC Oral Health. **Differences in heart rate at different time points compared with baseline were not statistically significant. Topical anesthetics include benzocaine, lidocaine, cocaine, proparacaine, and oxybuprocaine. 0000012603 00000 n Comparison of topical anesthetics without cocaine to tetracaine-adrenaline-cocaine and lidocaine infiltration during repair of lacerations: bupivacaine-norepinephrine is an effective new topical anesthetic agent. Convenient and quality service. Pain was assessed directly with visual analog scale (VAS) scores and indirectly by measuring changes in heart rate at 4 different time points. You can read the full text of this article if you: You may be trying to access this site from a secured browser on the server. However the product can be shipped to the doctors office so that it can be used on the individual patient when they come into the office for their procedure. 0000010584 00000 n Federal government websites often end in .gov or .mil. Some come in a spray or a patch that sticks to your skin. Blinding of both the patient and the clinician limited the bias and placebo effects. Get the FREE SingleCare app (9,650) . In most cases it should only be used under the supervision of a trained healthcare provider. Hi,I live w chronic pain,Ive had 2 back surgeries,1 neck surgery,Im 61,I have used Diclofenac 1%,it does nothing my ins.pay for it,how can I try or purchase the one you are selling at your pharmacy? Compounding is an essential component of precision medicine. 0000043302 00000 n Heart failure (HF) is a serious health and economic burden worldwide, and its prevalence is continuously increasing. Compounding medications for dermatology is a special class of precision medicine. Custom in-office peels blends that address everything from hyperpigmentation, skin tone, texture, acne and more. To explore the effectiveness of these creams, the researchers conducted a double-blind, randomized and placebo-controlled study at Walter Reed from August 2015 to February 2018. More than half (51 percent) were female. topical compounded pain medications. MeSH A digital pocket scale was used to weigh 0.25 g of the topical anesthetic. It can be vital, for example, to differentiate between gender and sex and determine whether the patient is male or female in order to tune treatments accordingly. 1997 Nov;100(5):825-30. doi: 10.1542/peds.100.5.825. You may need to wear latex gloves when applying the cream. Before Model fit was evaluated via q-normal plots of the residuals, and the likelihood ratio test was used to test differences between full and reduced candidate models. To compare the effectiveness of a combination of 10% lidocaine, 10% prilocaine, and 4% tetracaine versus 20% benzocaine for use as a topical anesthetic agent prior to dental injections. The researchers think there was a tiny difference favoring the pain creams because they contained two substanceslidocaine and prescription non-steroidal anti-inflammatory drugs, particularly ketoprofen and diclofenacthat were shown in earlier randomized trials to be effective topically. COPYRIGHT 2022. In fact, VAS scores were significantly higher in the experimental group and more postoperative issues, such as redness and tissue sloughing, were reported compared with the control group. No significant differences in heart rate at any of the 4 measured time points compared with baseline were noted for either group. Further studies should be done to test 10% lidocaine, 10% prilocaine, and 4% tetracaine and 20% benzocaine against a placebo group. Topical anesthetics are medications that can be applied directly to the skin to relieve pain. The hypothesis for this pilot study was that use of a CTA comprising 10% lidocaine, 10% prilocaine, and 4% tetracaine would be more effective than a topical anesthetic with 20% benzocaine for providing relief of pain during local anesthetic injection in adults. Kravitz ND, Graham JW, Nicozisis JL, Gill J. the contents by NLM or the National Institutes of Health. To learn more, visitReNue Rx. 0000014765 00000 n The USC Health Science Campus institutional review board approved this study. The most frequent cause for systemic toxicity from topical anesthetics is when patients apply the cream themselves under occulsion prior to laser hair removal of the legs. Compounded topical anesthetics also are available.14,15 Two of the more common formulations contain 20% lidocaine, 4% tetracaine, and 2% phenylephrine or 10% lidocaine, 10% prilo-caine, 4% tetracaine, and 2% phenylephrine.15 Compounded topical anesthetics have been used in orthodontic procedures for Evan M. Sisson is assistant professor at Virginia Commonwealth University's School of Pharmacy, Chester, VA. 0000039621 00000 n Martin MD, Ramsay DS, Whitney C, Fiset L, Weinstein P. Topical anesthesia: differentiating the pharmacological and psychological contributions to efficacy. People are unique, and that uniqueness is firmly apparent when you consider the skin of the face. They were also included if they were found to significantly predict VAS scores. Wolters Kluwer Health, Inc. and/or its subsidiaries. All rights reserved. In this study, no benefits were seen using a CTA of 10% lidocaine, 10% prilocaine, and 4% tetracaine versus 20% benzocaine prior to maxillary infiltration injections. Please enable scripts and reload this page. The combination gel is faster-acting and has a longer time of duration than commercially available products. There were more males in the control group (34.6%) than in the experimental group (23.1%). While it is true that compounded topical anesthetics are not FDA approved, over-the-counter numbing creams are not FDA approved either. J Dent Anesth Pain Med. Lidocaine topical jelly or ointment is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. 0000011474 00000 n The use of compound topical anesthetics: a review. 0000011063 00000 n This process varies from practice to practice based on physician personal preference. Topical analgesics and anesthetics (eg, creams, gels, patches) are formulated for local delivery to the skin, targeting sensory nerve endings and adjacent tissues after dermal penetration of the drug.2 Topical agents are gaining popularity for use in certain pain conditions, including For older people or those who can't tolerate oral NSAIDs, topical NSAIDs might be used instead. 2017;5:1. There were no statistically significant differences between the 2 groups in heart rate at the preinjection, injection, and postinjection time points when compared with their group's respective baseline (Figure). First, participants were randomly divided into two groupsone for the compounded topical cream and the other a placebo cream (both the real and placebo creams had the same consistency and feel). sharing sensitive information, make sure youre on a federal 0000101307 00000 n Until they become federally regulated, compound topical anesthetics remain unapproved drug products whose benefits may not outweigh their risks for dental patients. Your email address will not be published. Topical anesthetics are used for cosmetic procedures, laser treatments, and more. 0000001516 00000 n information and will only use or disclose that information as set forth in our notice of The use of these anesthetics has been associated with seizures, cardiac arrhythmias, and two deaths. [1] Topical anesthetics are available in creams, ointments, aerosols, sprays, lotions, and jellies. All anesthetics have the ability to cause toxicity. However, leaving the 10% prilocaine, and 4% tetracaine gel longer may have resulted in increased tissue sloughing and irritation. *Requires patient-specific prescriptions, and can be shipped and billed to the office if desired. Some of the patients had been treated with opiates in the past, but the percentage of those patients was not recorded. Compounded topical anesthetics like lidocaine 10% cream and BLT cream should in the majority of cases be administered under the supervision of a healthcare provider. All rights reserved. J Am Dent Assoc 2007;138:1333 - 9. Because lidocaine cream is allowed as an OTC, many manufacturers market these types of formulations without much oversight of their manufacturing processes. 0000004909 00000 n Commercially available lidocaine creams that are sold over-the-counter generally are made in strengths between 2-5%. Now, results of a rigorous federally funded study mandated by Congress shows no statistically significant difference between relief offered by these creams and placebos, according to researchers at Johns Hopkins Medicine and Walter Reed National Military Medical Center. 1998 May-Jun;11(3):200-6. doi: 10.3122/15572625-11-3-200. The procedure was conducted by 1 operator with the Wand injection system. Click here for an email preview. information submitted for this request. The Hosmer-Lemeshow test was used to assess for goodness of fit. your express consent. The staff is well trained and are willing to help you every step of the way. There were high retention rates for the participants, all outcomes were measured, and no missing data on outcomes were reported. All participants and the investigators were blinded as to which anesthetic they received. 2020 Aug;20(4):241-250. doi: 10.17245/jdapm.2020.20.4.241. Many people experience anxiety with visits to the dentist, but did you know that your pharmacist may be able to help with this? Read this article for more tips on using compounded numbing creams. Fifty-two participants were recruited by mass email in USC School of Dentistry's electronic list serve and by word of mouth and were offered a $10 gift card to compensate them for their time. Also, using too much can be toxic. From choosing the appropriate base, creating an all-in-one product, or removing allergens or toxic additives, we can provide a solution, even when all else has failed. There is a current epidemic of price hikes across indispensable dermatological medications. Explore New Drug Loft and VLS Pharmacys latest media features. Derry S, et al. After the procedure, immediately postinjection, the subjects were asked to rate their pain perception using the VAS. 15 0000008870 00000 n We are a 503A pharmacy what does that mean? Park L, Tom J, Bui N, Wilson M, Tanbonliong T. Anesth Prog. . 2018;355:6. We understand that a dermatologist's goal is to deliver patient satisfaction by working toward skin health and beauty. Generalized linear mixed models were used to evaluate the effect of treatment on heart rate across time. Often at least one of the ingredients is also found in an FDA-approved topical pain cream . Our pharmacists take the time to counsel you and answer your questions. A true sensitivity may be discovered through a test but usually this is outside the scope of what is done in a practice. Primary funding for the research came from the Center for Rehabilitation Sciences Research, Defense Health Agency, U.S. Department of Defense. Both types of topical anesthetic showed similar impacts on alterations to heart rate. Careers, Unable to load your collection due to an error. Meanwhile, Tulga and Mutlu20 observed 20% benzocaine to be more effective than EMLA for pain reduction of dental injections in their study of pediatric subjects. AnswerParadise.net, Your email address will not be published. In an effort to reduce chronic pain, many people look for hope by paying $20 to thousands of dollars for a tube of prescription topical pain cream or gel. The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group (p < .001). 0000014333 00000 n Micromedex. Unable to load your collection due to an error, Unable to load your delegates due to an error. 0000002298 00000 n A 27-gauge needle was advanced approximately 25 mm into the buccal vestibule. PATIENT RIGHTS | PRIVACY POLICY | RETURNS & SHIPPING | SITE MAP | PRESCRIPTION FORMS. Both topical anesthetics remained in contact with the gingival mucosa for 60 seconds. 0000002163 00000 n Cohen says that after the treatment period ended, the investigators found no statistically significant difference between the mean reduction in average self-reported pain scores for all patients in the treatment and placebo groups. A double-blind randomized prospective clinical trial was conducted with 26 participants receiving a topical anesthetic of 20% benzocaine (control) and 26 participants receiving a compound topical anesthetic mixture of 10% lidocaine, 10% prilocaine, and 4% tetracaine (experimental) prior to a maxillary infiltration injection. Participants were randomly assigned to either the 20% benzocaine control group or the 10% lidocaine, 10% prilocaine, and 4% tetracaine experimental group using a random number table generated using the runiform command in Stata (StataCorp, College Station, TX). Pingback: Is lidocaine good for sores? Drilling down further also makes sense. Symptoms and conditions do respond to the right treatment. 0000002852 00000 n 0000100184 00000 n The diaries were used to determine the outcomes. 0000002386 00000 n Compound topical anesthetics are neither FDA-regulated nor -unregulated. 347 0 obj <>stream We collaborate with prescribers to develop formulas to achieve just this! Topical NSAIDs, however, have a lower risk of stomach irritation. In summary, a CTA comprised of 10% lidocaine, 10% prilocaine, and 4% tetracaine was less effective than 20% benzocaine at reducing pain associated with the injection of local anesthesia. HHS Vulnerability Disclosure, Help FOIA Cohen cautioned that the new study was somewhat limited in terms of applicability for specific conditions, in part because of the wide variety of medical conditions and pain disorders among the participants. It can be identified by its aromatic, wintergreen smell. Effective topical anesthetic agents and techniques. In addition, capsaicin, a pepper derivative commonly used in lotions and creams for muscle pain, could not be used in the study compounds because the recognizable smell and application requirements would have undermined the double-blinding process that kept both caregivers and subjects unaware if they were getting active creams or placebos. This topic will discuss the mechanism of action of LAs, the properties that . 0000006327 00000 n Compounded topical anesthetic creams are significantly stronger than commercially available numbing creams. These higher-strength numbing creams are available only with a prescription. Can Vegans Benefit From A Compounded Multivitamin? It is now used both as an injection and topically for numbing before procedures and for pain relief. The aim of this study was to evaluate the efficacy of a CTA using 10% lidocaine, 10% prilocaine, and 4% tetracaine, which has been trademarked as Profound, in comparison with 20% benzocaine.13. 0000092473 00000 n PMC Deepika A, Rao CR, Vinay C, Uloopi KS, Rao VV. Unauthorized use of these marks is strictly prohibited. The PASS software, version 14 (Kaysville, UT) was used to calculate sample size.

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