The efficacy of antimicrobial treatment in children with acute otitis media remains controversial.
In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, ...diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.
Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval CI, 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).
Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.).
The assessment of ear pain is challenging in young, mostly preverbal children. Our aim was to investigate whether pain scales are useful tools for parents to detect pain in their young children with ...the suspicion of acute otitis media (AOM), and to assess associations between 16 symptoms and the severity of pain.
This cross-sectional study included 426 children (6-35 months) with symptoms suggestive of AOM. We surveyed symptoms and pain via parental interview. As part of the interview, parents assessed their child's pain by using two pain scales: The Faces Pain Scale-Revised (FPS-R) and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The outcome of interest was moderate/severe pain. We used the χ
test or Fisher's test as applicable to compare the severity of pain between three parental pain assessment methods (the parental interview, the FPS-R and the FLACC Scale). We also used multivariable logistic regression models to study the association between the severity of pain and AOM and to study the association between symptoms and the severity of pain.
In children with AOM (n = 201), pain was assessed by parents as moderate/severe in 65% via interview; 90% with the FPS-R; and 91% with the FLACC Scale (P < 0.001). In children without AOM (n = 225), the percentages were 56, 83 and 88%, respectively (P < 0.001). Between children with and without AOM, the occurrence of moderate/severe pain did not differ with any of the pain evaluation methods. Of symptoms, ear pain reported by child and restless sleep were significantly associated with moderate/severe pain, regardless of the pain evaluation method.
It seems that nearly all the children with respiratory tract infection, either with or without AOM, might suffer from moderate/severe pain. Without pain scales, parents may underestimate their child's pain. Of symptoms, ear pain reported by child and restless sleep might indicate pain in children with respiratory tract infection. We suggest that the adaptation of pain scales for parent observation is a possibility in children with respiratory tract infection which, however, requires further studies.
www.clinicaltrials.gov , identifier NCT00299455 . Date of registration: March 3, 2006.
Background Rhinovirus-induced early wheezing has been suggested as a new important risk factor for recurrent wheezing. Objective We sought to investigate the risk factors for recurrent wheezing and ...to determine post hoc the efficacy of prednisolone in risk groups. Methods We followed for 1 year 118 children (median age, 1.1 years) who had had their first episode of wheezing and had participated in a trial comparing prednisolone with placebo in hospitalized children. Demographics and laboratory data were obtained at study entry. The follow-up outcome was recurrent wheezing (3 physician-confirmed episodes). Results Recurrent wheezing was diagnosed in 44 (37%) children. Independent risk factors were age < 1 year, atopy, and maternal asthma. The probability of recurrent wheezing was higher in rhinovirus than respiratory syncytial virus (RSV)–affected children among placebo recipients (hazard ratio, 5.05; 95% CI, 1.00-25.41). Prednisolone decreased the probability of recurrent wheezing in children with eczema (0.15; 95% CI, 0.04-0.63) but not in those without eczema (1.89; 95% CI, 0.83-4.29; P = .007 for interaction). Prednisolone was associated with less recurrent wheezing in the rhinovirus group (0.19; 95% CI, 0.05-0.71), but not in the RSV (2.12; 95% CI, 0.46-9.76) or in the RSV/rhinovirus-negative groups (2.03; 95% CI, 0.83-5.00; P = .017 for interaction). Conclusion Rhinovirus-induced early wheezing is a major viral risk factor for recurrent wheezing. Prednisolone may prevent recurrent wheezing in rhinovirus-affected first-time wheezers. The presence of eczema may also influence the response to prednisolone. Clinical implications A prospective trial is needed to test the hypothesis that prednisolone reduces recurrent wheezing in rhinovirus-affected wheezing children.
The spectrum of acute symptoms in young outpatient children with respiratory tract infection (RTI) is variable, and it cannot be explained by the diagnosis of acute otitis media (AOM) versus ...uncomplicated RTI. We studied that the variation of symptoms is explained by the nasopharyngeal bacteria and/or respiratory viruses.
Children aged 6-35 months with acute symptoms with AOM (n = 201) or without AOM (n = 225) were eligible in this cross-sectional study. We analyzed their nasopharyngeal samples for pathogenic bacteria by culture and for respiratory viruses by polymerase chain reaction. We surveyed 17 symptoms (fever, respiratory, ear related, nonspecific, gastrointestinal) with a structured questionnaire.
Fever had a positive association with influenza viruses odds ratio (OR): 6.61; 95% confidence interval (CI): 1.66-26.27, human metapneumovirus (OR: 3.84; 95% CI: 1.25-11.77), coronaviruses (OR: 3.45; 95% CI: 1.53-7.75) and parainfluenza viruses (OR: 2.18; 95% CI: 1.07-4.47). Rhinitis (OR: 5.07; 95% CI: 1.93-13.36), nasal congestion (OR: 2.03; 95% CI: 1.25-3.31) and cough (OR: 1.91; 95% CI: 1.15-3.17) had positive associations with Moraxella catarrhalis. Furthermore, cough had a positive association with respiratory syncytial virus (OR: 7.20; 95% CI: 1.59-32.71) and parainfluenza viruses (OR: 2.79; 95% CI: 1.02-7.69).
The variation of acute symptoms in young children may be influenced by both nasopharyngeal bacteria and respiratory viruses. Our results showed a strong association between fever and respiratory viruses; rhinitis, nasal congestion and cough were associated with M. catarrhalis in the presence of viruses. Further studies are required to determine the possible synergistic role of M. catarrhalis in symptoms of RTI.
Treatment guidelines for acute otitis media (AOM) have changed over the past 20 years. Watchful waiting is often recommended as an option for antibiotic treatment and the use of proper pain ...medication is emphasised.
To study parental experiences and opinions regarding the management of AOM and compare our findings with our previous questionnaire submitted in 2006.
We sent an online survey link through day-care centres and Facebook parental groups in Turku area. Children <4 years of age attending day care were included in the analysis. We asked about the child's history of AOM, parental opinions about AOM treatment, and antibiotic resistance. Results of 2019 were compared with those of 2006.
Altogether 84% (320/381) and 83% (568/681) of children had had at least 1 episode of AOM in 2019 and 2006, respectively. In 2019, more children had been treated without antibiotics (30% vs. 13%, P < 0.001) and fewer parents thought that antibiotics are necessary for the treatment of AOM (70% vs. 85%, P < 0.001) compared with 2006. The use and knowledge of painkillers had increased over the past 13 years. Painkillers had been given at least once to 93% (296/320) of children in 2019 and 80% (441/552) of children in 2006 (P < 0.001).
Today, more parents accept watchful waiting as a treatment option for AOM and give painkillers to their children, which indicates that the education about optimal management of AOM has reached parents.
Rhinovirus is the most common virus causing respiratory tract illnesses in children. Rhinoviruses are classified into species A, B and C. We examined the associations between different rhinovirus ...species and respiratory illness severity.
This is a retrospective observational cohort study on confirmed rhinovirus infections in 134 children 3-23 months of age, who were enrolled in 2 prospective studies on bronchiolitis and acute otitis media, respectively, conducted simultaneously in Turku University Hospital, Turku, Finland, between September 2007 and December 2008.
Rhinovirus C is the most prevalent species in our study, and it was associated with severe wheezing and febrile illness. We also noted that history of atopic eczema was associated with wheezing.
Our understanding of rhinovirus C as the most pathogenic rhinovirus species was fortified. Existing research supports the idea that atopic characteristics are associated with the severity of the rhinovirus C-induced illness.
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