***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Abstract Objective : To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age . Design : Practice based , double blind , r and omised , placebo controlled trial . Setting : 53 general practice s in the Netherl and s. Subjects : 240 children aged 6 months to 2 years with the diagnosis of acute otitis media . Intervention : Amoxicillin 40 mg/kg/day in three doses . Main outcome measures : Persistent symptoms at day four and duration of fever and pain or crying , or both . Otoscopy at days four and 11 , tympanometry at six weeks , and use of analgesic . Results : Persistent symptoms at day four were less common in the amoxicillin group ( risk difference 13 % ; 95 % confidence interval 1 % to 25 % ) . The median duration of fever was two days in the amoxicillin group versus three in the placebo group ( P=0.004 ) . No significant difference was observed in duration of pain or crying , but analgesic consumption was higher in the placebo group during the first 10 days ( 4.1 v 2.3 doses , P=0.004 ) . In addition , no otoscopic differences were observed at days four and 11 , and tympanometric findings at six weeks were similar in both groups . Conclusions : Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child . This modest effect does not justify prescription of antibiotics at the first visit , provided close surveillance can be guaranteed OBJECTIVE To assess the analgesic and anti-inflammatory value of sodium Naproxen in the treatment of otitis . DESIGN A prospect i ve study . There were interventions , but no controls . There was not a r and om distribution of the sample . SITE . Outpatient clinics in a Sant and er hospital . PATIENTS AND OTHER PARTICIPANTS Patients presenting symptoms of acute or chronic otitis . INTERVENTIONS A group of 20 patients with acute otitis and a second group of 15 with chronic otitis were treated normally ; while 20 other patients suffering acute otitis and 17 with chronic otitis received in addition to normal treatment 550 mg of sodium naproxen every 12 hours . MAIN MEASUREMENTS AND RESULTS The evolution of the clinical description was evaluated along the following parameters : perforation of the tympanum , otorrhea , pain , vertigo , migraines , hypoacusis and audiometries in acute cases of otitis ; and all these and also tympanic biopsy in chronic cases . The results obtained indicated a statistically significant anatomical-pathological improvement in chronic cases of otitis treated with sodium naproxen ; whereas in cases of acute otitis , these differences were observed in parameters such as hypoacusis , tympanometry , perforation of the tympanum and effectiveness of and tolerance towards additional treatment with sodium Naproxen . CONCLUSIONS On the basis of the study 's results as well as the high level of tolerance and absence of undesirable effects , we made a positive evaluation of the introduction of the aforesaid anti-inflammatory into the normal treatment of cases of otitis Summary The efficacy and tolerability of nimesulide were compared with those of paracetamol in a nonblind r and omised study that recruited 110 children ( 64 males , 46 females ; aged 3 to 6 years ) with inflammation of the upper respiratory tract and fever .  Nimesulide suspension ( 1.5 mg/kg 3 times daily ) or paracetamol syrup ( 10 mg/kg 4 times daily ) were administered orally until fever resolved . Body temperature was recorded and local pain and general discomfort assessed . Three patients treated with nimesulide and 6 patients treated with paracetamol withdrew from the study as a result of adverse events , and 1 paracetamol-treated patient discontinued because of a requirement for therapy with steroids . Nimesulide was as effective as paracetamol in reducing fever , local pain , and general discomfort .  Nimesulide therefore appears to be at least as effective as paracetamol in terms of antipyretic and anti-inflammatory activity in children with inflammation of the upper respiratory tract and fever Objective To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol , ibuprofen , or both  , and to compare these costs with the benefits of each treatment regimen . Design Cost consequences analysis and cost effectiveness analysis conducted as part of a three arm , r and omised controlled trial . Participants Children between the ages of 6 months and 6 years recruited from primary care and the community with axillary temperatures ≥37.8 ° C and ≤41 ° C . Interventions Paracetamol , ibuprofen , or both drugs . Main outcome measures Costs to the NHS and to parents and carers . Cost consequences analysis at 48 hours and 5 days comparing cost with children ’s temperature , discomfort , activity , appetite , and sleep ; cost effectiveness analysis at 48 hours comparing cost with percentage of children “ recovered . ” Results Difficulties in recruiting children to the trial lowered the precision of the estimates of cost and some outcomes . At 48 hours , cost to the NHS was £ 11.33 for paracetamol , £ 8.49 for ibuprofen , and £ 8.16 for both drugs . By day 5 these costs rose to £ 19.63 , £ 18.36 , and £ 13.92 respectively . For parents and carers , the 48 hour costs were £ 23.86 for paracetamol , £ 20.60 for ibuprofen , and £ 25.07 for both , and the day 5 costs were £ 26.35 , £ 29.90 , and £ 24.02 respectively . Outcomes measured at 48 hours and 5 days were inconclusive because of lack of power ; the cost effectiveness analysis at 48 hours provided little evidence that one treatment choice was significantly more cost effective than another . At 4 hours ibuprofen and the combined treatment were superior to paracetamol in terms of the trial primary outcome of time without fever ; at 24 hours the combined treatment performed best on this outcome . Conclusions There is no strong evidence of a difference in cost between the treatments , but clinical and cost data together indicate that using both drugs together may be most cost effective over the course of the illness . This treatment option performs best and is no more expensive because of less use of healthcare re sources , result ing in lower costs to the NHS and to parents SUMMARY We conducted an epidemiological , observational cohort study to determine the incidence and complications of acute otitis media ( AOM ) in children aged < 6 years . Data on physician-diagnosed AOM were collected from retrospective review of medical charts for the year preceding enrolment and then prospect ively in the year following enrolment . The study included 5776 children in Germany , Italy , Spain , Sweden , and the UK . AOM incidence was 256/1000 person-years [ 95 % confidence interval ( CI ) 243–270 ] in the prospect i ve study period . Incidence was lowest in Italy ( 195 , 95 % CI 171–222 ) and highest in Spain ( 328 , 95 % CI 296–363 ) . Complications were documented in < 1 % of episodes . Spontaneous tympanic membrane perforation was documented in 7 % of episodes . Both retrospective and prospect i ve study results were similar and show the high incidence during childhood in these five European countries . Differences by country may reflect true differences and differences in social structure and diagnostic procedures Objective To assess strategies for advice on analgesia and steam inhalation for respiratory tract infections . Design Open pragmatic parallel group factorial r and omised controlled trial . Setting Primary care in United Kingdom . Participants Patients aged ≥3 with acute respiratory tract infections . Intervention 889 patients were r and omised with computer generated r and om numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice : advice on analgesia ( take paracetamol , ibuprofen , or both ) , dosing of analgesia ( take as required v regularly ) , and steam inhalation ( no inhalation v steam inhalation ) . Outcomes Primary : mean symptom severity on days 2 - 4 ; symptoms rated 0 ( no problem ) to 7 ( as bad as it can be ) . Secondary : temperature , antibiotic use , reconsultations . Results Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes . Compared with paracetamol , symptom severity was little different with ibuprofen ( adjusted difference 0.04 , 95 % confidence interval −0.11 to 0.19 ) or the combination of ibuprofen and paracetamol ( 0.11 , −0.04 to 0.26 ) . There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis ( presence of otalgia ; previous duration of symptoms ; temperature > 37.5 ° C ; severe symptoms ) , but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections ( ibuprofen −0.40 , −0.78 to −0.01 ; combination −0.47 ; −0.84 to −0.10 ) , equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem . Children might also benefit from treatment with ibuprofen ( ibuprofen : −0.47 , −0.76 to −0.18 ; combination : −0.04 , −0.31 to 0.23 ) . Reconsultations with new/unresolved symptoms or complications were documented in 12 % of those advised to take paracetamol , 20 % of those advised to take ibuprofen ( adjusted risk ratio 1.67 , 1.12 to 2.38 ) , and 17 % of those advised to take the combination ( 1.49 , 0.98 to 2.18 ) . Mild thermal injury with steam was documented for four patients ( 2 % ) who returned full diaries , but no reconsultations with scalding were documented . Conclusion Overall advice to use steam inhalation , or ibuprofen rather than paracetamol , does not help control symptoms in patients with acute respiratory tract infections and must be balanced against the possible progression of symptoms during the next month for a minority of patients . Advice to use ibuprofen might help short term control of symptoms in those with chest infections and in children . Trial registration IS RCT N 38551726 The purpose of this study was to compare antipyretic activity and evaluate tolerability of ibuprofen and paracetamol suspension in the treatment of febrile children . It was design ed as a double blind , parallel group , multiple dose study comparing ibuprofen ( 20 mg/kg/24 hours ) with paracetamol ( 50 mg/kg/24 hours ) given at six hourly intervals for a maximum of 12 doses . Children on paediatric wards between the ages of 0.2 and 12 years , with fever as defined by an axillary temperature > or = 37.5 degrees C , were included . The main outcome measures were : change in axillary temperature ; palatability of medication ; changes in irritability and clinical condition ; overall efficacy at the end of treatment ; and number and nature of adverse events . The mean temperature change from baseline at four hours was -1.8 degrees C and -1.6 degrees C in ibuprofen and paracetamol groups respectively . In both groups : median palatability score was ' no reaction ' ; median irritability score at end point was ' not irritable ' ; median score for change in clinical condition was ' improved ' ; and median score for overall efficacy was ' good effect ' . The proportion of patients experiencing adverse events was similar in both groups , the majority of events having doubtful or no relationship to therapy and being mild in severity . In conclusion , ibuprofen suspension was as effective and well tolerated as paracetamol in treatment of fever in young children OBJECTIVE To compare the antipyretic benefit of acetaminophen or ibuprofen monotherapy with an alternating regimen of both drugs in young children aged 6 to 36 months . DESIGN R and omized , double-blind , parallel-group trial . SETTING Three primary pediatric community ambulatory centers in central Israel . PARTICIPANTS A total of 464 children aged 6 to 36 months with fever . INTERVENTION Infants were assigned to receive either acetaminophen ( 12.5 mg/kg per dose every 6 hours ) ( n = 154 ) or ibuprofen ( 5 mg/kg per dose every 8 hours ) ( n = 155 ) or to receive alternating acetaminophen and ibuprofen ( every 4 hours ) ( n = 155 ) for 3 days after a loading dose . MAIN OUTCOME MEASURES Temperature , stress score , amount of antipyretic received , total days that the infant or caregiver was absent from day care or work , respectively , at the 3-day time point , recurrence of fever , and number of emergency department visits . RESULTS The group given the alternating regimen was characterized by a lower mean temperature , more rapid reduction of fever , receiving less antipyretic medication , less stress , and less absenteeism from day care as compared with the other groups ; all of the differences were statistically significant ( P < .001 ) . None of the regimens were associated with a significantly higher number of emergency department visits ( P = .65 ) or serious long-term complications ( P = .66 ) . The drug used for initial loading had no effect on outcome in any of the groups . 
    Output:
    
Very low quality evidence suggested that adverse events did not significantly differ between children treated with either paracetamol , ibuprofen or placebo .
Low quality evidence indicates that both paracetamol and ibuprofen as monotherapies are more effective than placebo in relieving short-term ear pain in children with AOM .