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Health ing to the Calvert formula based on 24-h collection workers administering chemotherapeutic drugs of urine for creatinine clearance and doses order propecia 5mg online hair loss yasmin. AUC stands for workers should not deal with chemotherapeutic area under the curve best order for propecia hair loss cure boots. Other staff should Dose (mg) = target AUC × (creatinine clearance + wear gloves while preparing discount propecia 5mg on line hair loss in men 2016, administering and dis- 25) posing these drugs and other items in contact with these drugs such as syringes cheap propecia 5 mg visa hair loss cure when, gloves, intravenous For more information on creatinine clearance lines. These items cannot be disposed of in an please see: http://en. When creatinine clearance is not avail- be burned separately. The following needs to be in able the following formula may be used: place when chemotherapy is being administered: 2 Carboplatin 300–400mg/m over 30 min • Treatment protocols, protocols for side- Cycles are given once in 3 weeks with clinical effect management, emergency protocols for assessment plus CA-125 levels (if available and extravasation. Neoadjuvant chemotherapy is being increas- • Safety guidelines for staff (e. The diagnosis is These protocols and plans often already exist at usually made after clinical examination, tumor national or tertiary level and you should identify markers (CA-125), imaging (CT scan is ideal) and facilities where you can be trained in these import- tissue biopsy. Neoadjuvant chemotherapy is indi- ant areas described above. Three courses cancer of carboplatin/paclitaxel are given. Surgery is then carried out in patients who respond to the chemo- Epithelial ovarian cancer therapy (see Chapter 28). Surgery is the cornerstone for the primary treat- The management of recurrent ovarian cancer ment of ovarian cancer. Once recurrence occurs, the from adjuvant chemotherapy following surgery. No additional The key determining factor is the platinum-free benefit in progression-free or overall survival was interval. This is the time between completion of 401 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS chemotherapy with carboplatin and diagnosis of The best option in this situation is six courses of recurrence. Patients should not be treated based on paclitaxel and carboplatin. If paclitaxel is not avail- raised CA-125 alone in the absence of clinical or able, then carboplatin alone can be used. Patients are treated with single- agent chemotherapy. There are a number of options Germ cell tumors of chemotherapeutic agents available to treat patients Germ cell tumors are generally chemosensi- in this setting. FIGO stage IA dysgerminoma and FIGO used in this situation are expensive. In the low- stage IA immature teratoma grade 1 do not need resource setting, one of the options for platinum- chemotherapy after surgery. All other germ cell resistant disease is oral etoposide 50mg twice a day tumor histological types and stages will need for 7 days every 21 days, increasing to 10 days and 10 chemotherapy. The like- 14,15 The standard treatment is the BEP regimen lihood of response is in the region of 20–25%. Blood In platinum-sensitive disease, there is a direct parameters need to be monitored closely and many relationship between the duration of the platinum- patients will need dose reduction. See Appendix 4 free interval and the response to further treatment, of Chapter 28. In platinum-sensitive disease (with Sex cord stromal tumors platinum-free interval ≥12 months), patients must be carefully assessed clinically as well as radiologic- Adjuvant chemotherapy may be considered for ally by CT scans. Selected patients may benefit high-risk stage I patients (stage IC, poorly differen- with repeat surgery, a surgical procedure called tiated, heterologous elements as well as those with secondary cytoreduction. Chemotherapy with pacli- benefit patients if the disease can be completely re- taxel and carboplatin in the standard fashion as des- sected at surgery, therefore careful selection of suit- cribed previously is the currently preferred option. The surgery should only be undertaken by surgeons with the necessary Endometrial cancer experience, expertise and skills. If complete re- The role of chemotherapy in endometrial cancer is section of the tumor is not achieved at an attempt controversial and has been discussed earlier in this at secondary cytoreduction, the patient will have chapter as well as in the Chapter 29 on cancer of the morbidity of the second surgery with no clini- the uterine corpus. There are additional criteria before em- versial) in adjuvant disease, chemotherapy is also barking on secondary cytoreductive surgery – the used in the recurrent setting when metastatic patient must have been optimally debulked at the disease is present. When paclitaxel/carbo- of the recurrent tumor could be achieved. Patients who have had secondary cytoreduction should receive the Carcinosarcoma of the uterus chemotherapy after recovery from the surgery. Patients who are not candidates for secondary cyto- These are aggressive tumors which have a poor reductive surgery should receive chemotherapy prognosis in spite of treatment. Following surgery, when they have signs or symptoms of the recurrence. Doxorubicin and ifos- • CMF and AC were equivalent in outcomes (re- famide with mesna is another regimen that is used currence, mortality) and superior to no chemo- in sarcomas of the uterus. They led to a reduction in mortality rates by 20–25%. Further details are given in • Taxanes added to anthracycline-based regimen Chapter 27. It Breast cancer has relatively few side-effects and the agents are often available in resource-poor settings. Where See Chapter 30 for the specific indications for available anthracycline-based regimens should be chemotherapy in breast cancer. Regimens with different dosages of anthra- ment for patients with stage I–III disease is cure and cyclines (e. FE100C) are used in different settings they should be treated with combination therapy but the EBCTCG trial showed no significant even at the cost of toxicity. Patients with stage IV difference in outcomes for regimens where only disease are treated with as little therapy as needed the anthracycline dose was increased. Cyclophosphamide 500 mg/m2 IV days 1+8 Newly diagnosed stage I–III breast cancer may Methotrexate 40 mg/m2 IV days 1+8 be treated on an out-patient basis. The gold stan- 5-Fluorouracil 500 mg/m2 IV days 1+8 dard for early breast cancer is a taxane-based regi- 3-Weekly AC or EC 4 cycles men, which is slightly superior to anthracycline-based 2 Adriamycin 60 mg/m IV day 1/epi- regimens for nodal-positive disease [relative risk 2 rubicin 90mg /m IV day 1 (RR) 0. However, the former may not be available in many resource-limited 4-Weekly CAF 6 cycles Cyclophosphamide 100mg/m2 IV day 1 settings. The Breast Health Global Initiative Adriamycin 30 mg/m2 IV day 1 (BHGI) recommends their use only for areas with 5-Fluorouracil 500 mg/m2 IV day 1 an enhanced level of resources (see Chapter 30). There are no well-designed studies on the best 4-Weekly CEF 6 cycles drug regimen in low-resource settings.
The trials that used two to four-fold higher than licensed doses of LTRA had a five-fold increased risk of liver enzyme elevation (3 trials discount propecia 5 mg otc hair loss in men zip up boots, RR 4 buy propecia 1mg with mastercard hair loss treatment using onion. Controller medications for asthma 169 of 369 Final Update 1 Report Drug Effectiveness Review Project 228 5 mg propecia free shipping hair loss in men 50s fashion, 229 One fair 16 week trial (N = 889) reported similar rates of overall adverse events (37 buy propecia hair loss zinc dosage. Combination products compared with Leukotriene Modifiers Summary of findings 127, 232-234 We found 4 RCTs meeting our inclusion/exclusion criteria for this comparison. All three compared low dose fluticasone plus salmeterol with montelukast. Two of the RCTs were in 127 adolescents and adults age 15 and older, one enrolled subjects over the age of six (~15% of 234 subjects were < 12 years of age), and one enrolled only children ages 6 to 14. Overall, ICS/LABA combinations and leukotriene modifiers have similar rates of overall adverse events and withdrawals due to adverse events based on limited direct evidence from 4 short-term trials. Detailed Assessment Direct Evidence 127, 232-234 We found 4 RCTs comparing low dose fluticasone plus salmeterol with montelukast. The trials are described in more detail in the Key Question 1 section of the report. The four trials reporting withdrawals due to adverse events reported similar rates for those treated with ML and those treated with FP/SM. The 3 trials reporting overall adverse events also reported similar rates between groups (Evidence Tables A and B). One trial reported a greater incidence of upper respiratory tract infections for those treated with FP/SM than those treated 127 with ML. ICS+LABA compared with ICS+LTRA (addition of LABA compared with LTRA to ongoing ICS therapy) Summary of findings 235 236-241 We found one systematic review with meta-analysis and six RCTs that compared the addition of a LABA with the addition of an LTRA for patients poorly controlled on ICS therapy. All six of the RCTs were in adolescents and adults ≥ 12 years of age. Overall, results from a good quality systematic review with meta-analysis and six RCTs provide moderate evidence that there is no difference in overall adverse events or withdrawals due to adverse events between subjects treated with ICS plus LABA therapy and subjects treated with ICS plus LTRA therapy. Trials were generally not designed to compare tolerability and adverse events. We found no RCTs enrolling children < 12 years of age; the systematic review included just one trial in children (that did not contribute data to the meta-analysis). Thus, there is insufficient evidence to draw conclusions in children < 12 years of age. Controller medications for asthma 170 of 369 Final Update 1 Report Drug Effectiveness Review Project Detailed Assessment Direct Evidence 235 236-241 We found one systematic review with meta-analysis and six RCTs. All six of the RCTs were in adolescents and adults ≥ 12 years of age. Of the included studies (Evidence Tables A), all six compared montelukast plus fluticasone with salmeterol plus fluticasone. The trials are described in the Key Question 1 section of the report. The systematic review reported no significant differences in overall adverse events (8 studies, RR 1. There was a statistically significant difference in risk of oral moniliasis (6 studies, 1% for LABA compared with 0. All but one of the six RCTs meeting our inclusion criteria were included in the systematic review and they reported findings consistent with the conclusions of the meta-analysis (Evidence Tables A). Are there subgroups of these patients based on demographics (age, racial groups, gender), asthma severity, comorbidities (drug-disease interactions, including obesity), other medications (drug-drug interactions), smoking status, genetics, or pregnancy for which asthma controller medications differ in efficacy, effectiveness, or frequency of adverse events? Summary of findings We did not find any studies that directly compared the efficacy or adverse events of our included drugs between subgroups and the general population. In head-to-head comparisons, few subgroups based on age, racial groups, sex, other medications, or comorbidities were evaluated. We did not find any studies meeting our inclusion/exclusion criteria that directly compared our included medications and found a difference in the comparative efficacy, tolerability, or adverse events. Age Differences in efficacy, tolerability, and adverse events between children < 12 years of age and adolescents or adults ≥ 12 are described in the body of the report (Key Questions 1 and 2) in the appropriate sections. These differences are also noted in the overall summary table. Only a few trials have studied the efficacy and safety of asthma medications in very young children (less than three years). Budesonide inhalation suspension is the only ICS that is approved for use in children down to 12 months of age (see Introduction, Table 2). We found no head-to-head studies comparing the efficacy or safety of our included drugs in very young children with older children, adolescents, or adults. Long-term clinical trials have shown ICS 1 treatment to be effective in this population. Some evidence from placebo-controlled trials Controller medications for asthma 171 of 369 Final Update 1 Report Drug Effectiveness Review Project suggests that montelukast may be effective in children ages two to five; however, one trial reported that montelukast did not reduce the need for oral systemic corticosteroids to control 1 exacerbations. Most recommendations for treatment are based on limited data and 1 extrapolations from studies in older children and adults. This data, as well as expert opinion, 1 supports the use of ICSs for the treatment for asthma in young children. A pooled analysis of 5 placebo-controlled trials of omalizumab aimed to evaluate the effectiveness of omalizumab among adolescents (n=146) with moderate to severe allergic asthma 289 (a subset of the subjects enrolled in the 5 trials). In this population, omalizumab improved asthma symptom scores and resulted in fewer exacerbations, school days missed, and unscheduled office visits (Evidence Tables B). Racial groups We did not find any head-to-head studies that directly compared the efficacy and tolerability of our included drugs between one ethnic population and another. Two studies performed subgroup analyses; results may provide indirect evidence of differences between racial groups (Table 30). A good systematic review examined both efficacy and safety outcomes of studies comparing LABAs to placebo in “real world” asthmatic populations in which only some patients 283 were using regular ICSs at baseline. This study is described in detail in the Key Question 2 section of this report. A post-hoc subgroup analysis indicated that African Americans may be more likely to experience respiratory-related death and life threatening adverse events than Caucasians (Relative Risk Increase 3. There was, however, no significant difference found in asthma-related deaths between African Americans and Caucasians; results from life table analyses were not significantly different between African Americans (7 compared with 1; RR 7. This study is described in detail in Key Question 2. The trial found no statistically significant difference between those treated with salmeterol and those treated with placebo for the primary outcome, respiratory-related deaths or life-threatening experiences (50 compared with 36; RR 1. However, the trial reported statistically significant increases in respiratory-related deaths (24 compared with 11; RR 2. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. The increased risk was thought to be largely attributable to the African- American subpopulation: respiratory-related deaths or life-threatening experiences (20 compared with 5; RR, 4. The FDA released a safety alert based on the results of the trial, reporting that there were no significant differences in asthma-related events between salmeterol and placebo in Caucasian patients; however, in African Americans, there was a statistically significantly greater number of asthma-related events, including deaths, in salmeterol- compared with placebo-treated 290 patients. Controller medications for asthma 172 of 369 Final Update 1 Report Drug Effectiveness Review Project One fair quality multicenter trial compared montelukast (10 mg/d plus salmeterol (100 mcg/d plus placebo ICS) with low dose BDP (160 mcg/d plus salmeterol 100 mcg/d plus placebo 243 LTRA) for 14 weeks, washout for 4 weeks, then crossover for another 14 weeks.
Postoperativeanalgesia(acetam inophen10-25 m g/kg)wasgiventotheolderchildrenwhentheycom plainedof painandtotheyoungerchildrenwhentheywererestlessandcrying discount propecia uk hair loss cure 4 hunger. R esidualm uscularrelax ationwasnotantagoniz edpharm acologically order 1mg propecia with mastercard hair loss in men 1920s. D uring ex tubation buy 5 mg propecia with amex hair loss cure 3 plus,therewas aslittlestim ulationandsuctionof theairwayaspossibletoavoiddisturbing thechildandstim ulating gagging purchase propecia 1 mg line hair loss in men over 30. Contam inationof them outh and endotrachealtubebym ethylenebluewasassessed. Antiemetics Page 359 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 9. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or Y ear A llow oth er R un-in/ Setting Design Exclusioncriteria Intervention m edication W ash out O lutoye D BR CT Ptswith ASA physicalstatusof ≥ III,aprevioushistoryof D olasetroniv45m icrogram s/kg Allsubjectsreceived N o/N o 2003 Parallel gastroesophagealreflux ,vom iting from organic causes, D olasetroniv m idaz olam 0. Children D olasetroniv undergoing tonsillectom yandadenoidectom yprocedures 700m icrogram s/kg wereex cludedbecausetheyroutinelyreceivesteroidsat O ndansetroniv thisinstitution. A historyof PO V orm otionsicknesswas 100m icrogram s/kg notedduring thepreanaesthetic evaluationbutdidnot precludeenrollm ent. Sukh ani D BR CT Childrenwhoreceivedantiem etics,antihistam inics,or D olasetroniv0. Alsoex cludedwerechildrenwhohadahistory (m ax im um 20m g)po of diabetesandthosewhorequiredanivinduction,i. Antiemetics Page 360 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 9. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or A ge/ Screened/ W ith drawn/ Y ear G ender/ Eligible/ L ostto fu/ Setting Eth nicity Enrolled A nalyz ed O th erpopulationch aracteristics O lutoye 6. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or Y ear Setting R esults A dverse Events O lutoye data givenas Dol45 vs Dol175 vs Dol350 vs Dol700 vs O nd 100 N R 2003 F reedom from postoperativeem etic sym ptom s;com pleteresponse:noem esis,norescue SingleCenter for0-6h:54. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or Y ear Setting C om m ents O lutoye Afteram inim alfastof 2h (forclearliquids),allptsreceivedm idaz olam 0. O f 216ptsoriginally 2003 enrolled,1subjectwasex cludedfrom analysisafterrequiring additionalsurgery,and8wereex cludedbecauseof protocolviolations(caudal SingleCenter epiduralanalgesia,additionalintraoperativeopioids,orotherantiem etics);and3ptswerelosttofollowup;204ptsanalyz ed. Ptswith severepain(CHE O PS >8)receivedIV m orphine(increm entsof 0. M ildpain(CHE O PS 3-5)treatedwith oralacetam inophen10-15m g/kg. Ptswith postop em esiswhilestill inhospitalreceivedrescue:IV ond0. If IV accessnolongeravailable,trim ethobenz am ide(Tigan),100-200m g prescribedforrectaladm inistration. O ralintakeperm itted butnotm andatorybeforedischarge(criteriaincludedafullyawakeptwhorecogniz edtheparents,with stablevitalsigns,andwhowasfreefrom pe N ausea,asubjectivefeeling of em esis,notassessedinthisstudyduetoyoung ageof pts. AE s:"Therewerenodifferences intheincidenceof nonem etic AE s. Sukh ani Solidfoodsperm itteduntilm idnightbeforethedayof surgery,andclearliquidsperm itteduntil3h beforestartof theex pectedsurgery. All 2002 receivedoralprem edicationconsisting of m idaz olam 0. E ach patient SingleCenter receivedanacetam inophen30m g/kg suppository,fentanyl1m icrogram /kg IV,anddex am ethasone1m g/kg (m ax im um 25m g)IV beforethe startof surgery. Thisinform ationonlyincludestheH2H portionof thisstudy;theplacebogroup consistedof 50patientsandtheirdatawasnotincludedinthisabstraction. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or Y ear A llow oth er R un-in/ Setting Design Exclusioncriteria Intervention m edication W ash out M ecklenburg 2006 Ptswereex cludedif theywere1)underthecareof a D olasetroniv12. Antiemetics Page 364 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 9. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or A ge/ Screened/ W ith drawn/ Y ear G ender/ Eligible/ L ostto fu/ Setting Eth nicity Enrolled A nalyz ed O th erpopulationch aracteristics M ecklenburg 2006 33. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or Y ear Setting R esults A dverse Events M ecklenburg 2006 Antiemetics Page 366 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 9. Preventionofpostoperative nauseaand vom iting:H ead-to-h ead trials A uth or Y ear Setting C om m ents M ecklenburg 2006 Antiemetics Page 367 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Screened/ W ith drawn/ Y ear R un-in/W ash Eligible/ L ostto fu/ Setting Exclusioncriteria out Enrolled A nalyz ed A dults Dolvs O nd Birm ingham U nderthecareof am entalhealth-careprovider,physicalstatusASA classIII orhigher, N o/N o N R /N R /100 N R /N R /100 2006 pregnant,taking m edicationswith antiem etic propertieswithin48hoursbeforesurgery, SingleCenter presenting forinpatientsurgery,requiring adm issiontothehospitalforsurgicalreasons,not receiving generalanesthesia Browning Ptsex cludedif theywere<18,pregnant,receivedandASA physicalclassificationof ≥ III, N R /N R N R /N R /212 N R /N R /212 2004 ex periencedem esis24h priortoprocedure,orreceivedantiem etic m edicationor SingleCenter investigationalresearch drug 24h priortosurgery. Paech Ptsex periencing preoperativenausea,receiving m edicationwith antiem etic activityorwith N o/N R N R /N R /120 2/0/118 2003 contraindicationtononsteroidalanti-inflam m atorym edicationorepiduralanesthesiawere SingleCenter ex cludedfrom thisstudy. W om eninwhom anopenprocedureswasnotperform edorwho underwentunplannedbowelsurgerywereex cluded. Tang E x clusioncriteriaincludedpregnancy;activem enstruation;bodyweightm orethat50% above N o/N o N R /N R /135 0/0/135 2003 theidealbodyweight;vom iting orretching within24h beforetheoperation;adm inistrationof SingleCenter antiem etic orpsychoactivem edicationwithin24h beforesurgery;aprevioushistoryof severe (orunstable)cardiovascular,respiratory,m etabolic,endocrine,orneurologic disease;alcohol ordrug abuse;andim pairedrenalorhepatic function. Zarate Ptsex cludedif theyhadreceivedanantiem etic m edicationwithin24h beforetheiroperation, N o/N o N R /N R /200 0/0/200 2000 werepregnant,hadclinicallysignificantcardiovascular,neurologic,renal,hepatic, SingleCenter gastrointestinal,orendocrinologicaldiseases,hadahistoryof drug abuse,orwere>100% abovetheiridealbodyweight E rhan ASA classIII-IV;aged>70years;BM I >30;pregnancy;sm oking;signsof gastrointestinal, N R /noopiodis N R /N R /80 N R /N R /80 2008 endocrine,renal,hepatic orim m unologicaldisease;useof opioidsortranquilliz erslessthan1 ortranquilliz ers SingleCenter weekbeforetheoperation;treatm entwith steroids;historyof alocoholordrug abuse;history within1week of m otionsickness;preoperativediagnosisof gallbladderem pyem aandpreviousendoscopic of surgery sphincterotom yforcom m onbileductstones;andconversiontoopencholecystectom y. Antiemetics Page 368 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A ttrition A uth or G roups Eligibility C rossover Y ear sim ilarat criteria C are provider Patients A dh erence L oss to Setting R andom iz ation A llocation baseline specified m asked m asked C ontam ination follow up A dults Dolvs O nd Birm ingham N R N R Yes Yes Yes Yes N R U nableto 2006 N R determ ine SingleCenter N R N R Browning Yes Yes Yes,although Yes Yes Yes N o U nableto 2004 nodatagiven N o determ ine SingleCenter N o N o Paech Yes Yes Yes Yes N o Yes Yes N o 2003 N o SingleCenter N o N o Tang Yes N R Yes Yes Yes N R ,butis Yes N o 2003 "doubleblind"N o SingleCenter N o N o Zarate Yes N R Yes Yes N R ,"double N R Yes N o 2000 blind" N o SingleCenter N o N o E rhan Yes Yes Yes Yes Yes Yes N o N o 2008 N o SingleCenter N o N o Antiemetics Page 369 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Y ear Intention-to-treat Postram dom iz ation C ontrolled group Setting analysis exclusions Q uality rating standard ofcare F unding A dults Dolvs O nd Birm ingham U nclear U nabletodeterm ine F air N o N R 2006 SingleCenter Browning U nabletodeterm ine U nabletodeterm ine F air Yes N R 2004 SingleCenter Paech Yes Yes,only2 F air Yes A sm allproportionof each studydrug was 2003 suppliedfreebytherespective SingleCenter pharm aceuticalcom panies(N ovartisfor trop. Tang Yes N o F air Yes Theclinicalresearch fellowshipswere 2003 supportedbydepartm entalresources. SingleCenter Thisstudywasalsosupportedbythe W hiteM ountainInstitute,anot-for-profit privatefoundationinL osAltos,California (D r. Zarate Yes N o F air Yes N R 2000 SingleCenter E rhan N R N o F air Yes N R 2008 SingleCenter Antiemetics Page 370 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Screened/ W ith drawn/ Y ear R un-in/W ash Eligible/ L ostto fu/ Setting Exclusioncriteria out Enrolled A nalyz ed K ushwaha G astrointestinaldisorders,pregnancyorm enstruation,historyof m otionsicknessorprevious N R /N R N R /N R /125 N R /N R /125 2007 historyof PO N V,aged<10yearsor>60years. SingleCenter M eyer Ptswereex cludedforanyof thefollowing reasons:1)thepatientdeclinedparticipation,2)the N R /N R 559/351/92 N R /N R /92 2005 physicianresponsibleforpatientcareconsideredthestudynottobeinthebestinterestof SingleCenter thepatientforanyreason,3)thepatientwasallergic toeitherprim arystudydrug,or4)the patientwasunableto understandthestudy. K ortilla Ptsscheduledforpost-operativegastric suctioning orptswhohadingestedanydrug with N R /N R N R /N R /518 1/3/514 1997 antiem etic efficacywithin24h beforesurgery. O therex clusioncriteriaincludedclinically M ulticenter significantcardiac orliverdisease,abnorm alprestudyserum potassium levels,obesity(40% aboveidealbodyweight),nauseaandvom iting within24h priortosurgery,previoustreatm ent with dolasetronm esilate,useof anyinvestigationaldrug within30daysof dolasetron adm inistration,orknownalcoholabuse. G ranvs O nd B h atnagar Ptswith gastrointestinaldisease,thosewhowerem enstruating,orthosewhohadreceived N o/N o N R /N R /90 0/0/90 2007 anyantiem etic m edicationwithin24hoursof thesurgery D ua Ptswith knownstom ach disorders,historyof heartburn,m otionsickness,perviousPO N V, N one/N o N R /N R /60 N R /N R /N R 2004 loweresophagealsphincterdisorders,m enstruation,uncontrolledhypertension,poorly SingleCenter controlleddiabetes,orpre-operativeem esislessthat12h priortosurgerywereex cluded. G an Ptswereex cludedif they1)hadknownhypersensitivityof contraindicationtostudy N o/N R N R /N R /210 34/0/176 2005 m edications,2)hadchronic nauseaandvom iting orex periencedretching,vom iting,or M ulticenter m oderateorseverenauseainthe24h beforeanesthesia,3)hadreceivedanantiem etic drug oradrug with antiem etic propertiesduring the24h beforeanesthesia,4)hadabodym ass inde ≥ 36 5) erepregnantorbreastfeeding or6)hadaconditionreq iring chronic opioid Antiemetics Page 371 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A ttrition A uth or G roups Eligibility C rossover Y ear sim ilarat criteria C are provider Patients A dh erence L oss to Setting R andom iz ation A llocation baseline specified m asked m asked C ontam ination follow up K ushwaha N o N R Yes Yes N R N R N o N o 2007 N o SingleCenter N o N o M eyer Yes Yes Yes Yes Yes Yes Yes N o 2005 N o SingleCenter Yes N o K ortilla N R N R Yesbutfor Yes N R N R Yes N o 1997 weight N o M ulticenter N o N o G ranvs O nd B h atnagar Yes Yes Yes Yes Yes Yes Yes N o 2007 N o Yes N R D ua Yes N R Yes Yes Yes N R N o N R 2004 N o SingleCenter N o N o G an Yes Yes Yes Yes Yes Yes Yes N o 2005 N o M ulticenter Yes N R Antiemetics Page 372 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Y ear Intention-to-treat Postram dom iz ation C ontrolled group Setting analysis exclusions Q uality rating standard ofcare F unding K ushwaha N R N o Poor Yes N R 2007 SingleCenter M eyer Yes Yes;51/143= 36%;".. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Screened/ W ith drawn/ Y ear R un-in/W ash Eligible/ L ostto fu/ Setting Exclusioncriteria out Enrolled A nalyz ed Janicki Ptswereex cludedfor:pregnancyorbreastfeeding,useof propofolform aintenanceof N R /N R N R /N R /159 6/3/150 2006 anesthesia,allergytostudym edication,neuroax ialanesthesia,historyof vom iting within24 HersheyM edical hoursbeforeanesthesia,historyof cardiaarrhythm iaand/orhistoryof antiarrhythm ic therapy, Center andhistoryof vom iting from anyorganic etiology. N aguib Patientswhowerereceiving drugsknowntohaveantiem etic effects(such astricyclic N o/N A N R /N R /132 0/0/132 1996 antidepressants,scopolam ine,phenothiaz ines,loraz epam ,corticosteroids,and N R trim ethobenz am ides. Ptswerealsoex cludedif theyhadex periencednauseaorvom iting of it they hadtakenantiem etic treatm entinthe48h beforesurgery.