Effect of Topical Antibiotics on Duration of Acute Infective Conjunctivitis in Children: A Randomized Clinical Trial and a Systematic Review and Meta-analysis.

Importance: Although topical antibiotics are often prescribed for treating acute infective conjunctivitis in children, their efficacy is uncertain. Objective: To assess the efficacy of topical antibiotic therapy for acute infective conjunctivitis. Design, Setting, and Participants: A randomized clinical trial was conducted in primary health care in Oulu, Finland, from October 15, 2014, to February 7, 2020. Children aged 6 months to 7 years with acute infective conjunctivitis were eligible for enrollment. The participants were followed up for 14 days. A subsequent meta-analysis included the present trial and 3 previous randomized clinical trials enrolling pediatric patients aged 1 month to 18 years with acute infective conjunctivitis. Interventions: Participants in the present randomized clinical trial were randomized to moxifloxacin eye drops, placebo eye drops, or no intervention. Main Outcomes and Measures: The primary outcome in the present randomized clinical trial was time to clinical cure (in days); in the meta-analysis, the primary outcome was the proportion of participants with conjunctival symptoms on days 3 to 6. Results: The randomized clinical trial included 88 participants (46 [52%] girls), of whom 30 were randomized to moxifloxacin eye drops (mean [SD] age, 2.8 [1.6] years), 27 to placebo eye drops (mean [SD], age 3.0 [1.3] years), and 31 to no intervention (mean [SD] age, 3.2 [1.8] years). The time to clinical cure was significantly shorter in the moxifloxacin eye drop group than in the no intervention group (3.8 vs 5.7 days; difference, -1.9 days; 95% CI, -3.7 to -0.1 days; P = .04), while in the survival analysis both moxifloxacin and placebo eye drops significantly shortened the time to clinical cure relative to no intervention. In the meta-analysis, a total of 584 children were randomized (300 to topical antibiotics and 284 to a placebo), and the use of topical antibiotics was associated with a significant reduction in the proportion of children who had symptoms of conjunctivitis on days 3 to 6 compared with placebo eye drops (odds ratio, 0.59; 95% CI, 0.39 to 0.91). Conclusions and Relevance: In this randomized clinical trial and systematic review and meta-analysis, topical antibiotics were associated with significantly shorter durations of conjunctival symptoms in children with acute infective conjunctivitis. Trial Registration: ClinicalTrialsRegister.eu Identifier: 2013-005623-16.

Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial.

IMPORTANCE: Antimicrobial treatment reduces the symptoms of acute otitis media (AOM). The effect of antimicrobial treatment on the duration of middle ear effusion (MEE) and concomitant hearing impairment is not known. OBJECTIVE: To determine whether the antimicrobial treatment of AOM reduces the duration of MEE. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled trial involved a total of 84 children with AOM between 6 months and 15 years of age. Participants were recruited from September 14, 1999, to January 4, 2000; October 10, 2005, to December 16, 2005; and September 22, 2009, to June 4, 2012, from among children attending an AOM prevention trial and children visiting local outpatient clinics in Oulu, Finland. INTERVENTIONS: Children were randomly allocated to receive either 40 mg/kg of amoxicillin-clavulanate or a placebo mixture per day for 7 days. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the time to the disappearance of MEE as defined by a normal tympanogram finding (A curve) from both ears on 2 consecutive measurement days. Parents performed daily tympanometry at home. The study physician performed tympanometry and otoscopy at study entry, after 3 and 7 days, and then weekly until both ears were healthy. The main secondary outcome measures were the time to normal otoscopy findings and the proportion of children without persistent MEE at 14 days and 2 months. RESULTS: Middle ear effusion disappeared 2.0 weeks (13.7 days) earlier (P = .02) in the antimicrobial group (mean time, 2.7 weeks; 95% CI, 1.7-3.7) than in the placebo group (4.7 weeks; 95% CI, 3.6-5.7). Normal otoscopy findings were observed 1.4 weeks sooner in the antimicrobial group than in the placebo group (P = .02). On day 14, 69% of children in the antimicrobial group and 38% in the placebo group had normal tympanometry findings (number needed to treat, 3.2; 95% CI, 2.0-10.5). On day 60, 2 children (5%) in the antimicrobial group and 10 children (24%) in the placebo group had persistent MEE (P = .01). CONCLUSIONS AND RELEVANCE: Antimicrobial treatment effectively reduced the duration of MEE and possible concomitant hearing impairment in children with AOM. Antimicrobial treatment also reduced the risk for persistent MEE. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01244581.

Quality of life after surgery for recurrent otitis media in a randomized controlled trial.

BACKGROUND: Tympanostomy with or without adenoidectomy is effective in preventing recurrences of acute otitis media (RAOM), but little is known about the effect of these operations on the quality of life (QOL). We evaluated the efficacy of insertion of tympanostomy tubes with and without adenoidectomy for improving QOL in young children in a controlled, randomized trial. METHODS: QOL was evaluated in the 159 children aged 10 months to 2 years participating in our larger study in which children with RAOM were randomly assigned to receive tympanostomy tubes, tympanostomy tubes with adenoidectomy or neither. The caregiver of the child completed otitis media-specific QOL questionnaires (Otitis Media-6) at entry and after 4 months and 12 months of follow up. RESULTS: Scores on the global ear-related QOL and the subsets of caregiver concern, emotional distress and physical suffering in the questionnaires improved with time during the follow up, but the groups did not differ from each other. CONCLUSIONS: QOL in children with RAOM improves with time when the subjects are closely followed. Tympanostomy with adenoidectomy does not provide any additional QOL benefit for children with RAOM, even though these operations are effective in preventing further otitis media episodes.

Short-term outcomes of tonsillectomy in adult patients with recurrent pharyngitis: a randomized controlled trial.

BACKGROUND: Limited evidence exists as to the benefit of tonsillectomy in adult patients. We sought to determine the short-term efficacy of tonsillectomy for recurrent pharyngitis in adults. METHODS: We conducted a randomized, controlled, parallel-group trial at a tertiary care ear, throat and nose centre in Oulu, Finland, between October 2007 and December 2010. Adult patients with recurrent pharyngitis were randomly assigned to the control group (watchful waiting) or the tonsillectomy group. Our primary outcome was the difference in the proportion of patients with severe pharyngitis (severe symptoms and C-reactive protein level > 40 mg/L) within 5 months. Our secondary outcomes included differences between groups in proportions of patients who had episodes of pharyngitis with or without medical consultation, rates of pharyngitis and numbers of days with symptoms. RESULTS: Of 260 patients referred for tonsillectomy because of recurrent pharyngitis, we recruited 86 participants for our study. Of these, 40 patients were randomly allocated to the control group, and 46 were randomly allocated to the tonsillectomy group. One patient in the control group and no patients in the tonsillectomy group had a severe episode of pharyngitis (difference 3%, 95% confidence interval [CI] -2% to 7%). Seventeen patients in the control group (43%) and 2 patients in the tonsillectomy group (4%) consulted a physician for pharyngitis (difference 38%, 95% CI 22% to 55%). Overall, 32 patients in the control group (80%) and 18 patients in the tonsillectomy group (39%) had an episode of pharyngitis during the 5-month follow-up (difference 41%, 95% CI 22% to 60%). The rate of pharyngitis and number of symptomatic days were significantly lower in the tonsillectomy group than in the control group. INTERPRETATION: There was no significant difference in the number of episodes of severe pharyngitis between the control and treatment groups, and episodes were rare. However, tonsillectomy resulted in fewer symptoms of pharyngitis, consequently decreasing the number of medical visits and days absent from school or work. For this reason, surgery may benefit some patients. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT00547391.

Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial.

BACKGROUND: The prevention of otitis media, particularly among infants, remains a controversial issue. We evaluated the efficacy of insertion of tympanostomy tubes with and without adenoidectomy for preventing recurrent acute otitis media (AOM) in young children. METHODS: We randomly assigned 300 children aged 10 months to 2 years who had recurrent AOM to groups receiving tympanostomy tubes (Tymp) (n = 100), tympanostomy tubes with adenoidectomy (TympAde) (n = 100) or neither (Contr) (n = 100). All the children were followed up for 12 months. RESULTS: The primary outcome was intervention failure (2 AOM episodes in 2 months, 3 in 6 months or persistent effusion lasting for 2 months). Intervention failed in 21% of cases (21/100) in the Tymp group, 16% (16/100) in the TympAde group and 34% (34/100) in the Contr group. The absolute differences were -13% [95% confidence interval (CI) -25% to -1%, P = 0.04] between the Tymp and Contr groups and -18% (95% CI -30 to -6%, P =0.004) between the TympAde and Contr groups. CONCLUSIONS: Insertion of tympanostomy tubes alone or with adenoidectomy was effective in preventing recurrent AOM episodes in children younger than 2 years of age.

[It's normal--structural and functional variations of nose and paranasal sinuses]. / Se on ihan normaalia- -nenän ja sivuonteloiden rakenteiden ja toiminnan variaatioita.

Many nasal symptoms can be caused by normal variation in nasal structure or functioning. External nasal deformity necessitates further examinations only when remarkable or causing nasal blockage. Septal deformities are often seen also in patients without any symptoms. The size of nasal turbinates and the number or size of paranasal sinuses may vary causing sometimes problems in the interpretation of radiological imaging. Abnormal radiological findings can be detected also in asymptomatic patients, most commonly mucosal thickening and cysts of paranasal sinuses. Meticulous clinical examination including decongestation of nasal mucosa is a key for sorting out meaningful connection between symptoms and findings.

Timing of rhinosinusitis complications in children.

BACKGROUND: Acute rhinosinusitis in a child with signs and symptoms of a cold that persist beyond 10 days is recommended to be treated with antimicrobials. One reason for this recommendation is to prevent the complications of sinus infection. We wanted to find out whether there is any evidence to support this. METHODS: We reviewed retrospectively all the medical records of children treated in our hospital from February 1996 to March 2006 for complications related to rhinosinusitis. RESULTS: Twenty children had such complications. Their symptoms of uncomplicated acute respiratory infection had lasted for an average of 5.1 days before the appearance of the complication, and only 3 children had respiratory symptoms lasting longer than 10 days. CONCLUSIONS: Complications of rhinosinusitis in children appear during the first few days of acute upper respiratory infection. This finding does not support the recommendation that antibiotics should be started if upper respiratory symptoms have lasted longer than 10 days in children. Even though patients with findings suggesting invasive periorbital infection require immediate antimicrobial treatment, we should be critical in our recommendations as to when antibiotics need to be given to patients with only prolonged upper respiratory infections.

Nasal middle meatal specimen bacteriology as a predictor of the course of acute respiratory infection in children.

AIMS: To test our hypothesis that children with potentially pathogenic bacteria (Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis) in the nasal middle meatus might have more prolonged symptoms of acute respiratory infection than children without such bacteria, we conducted a prospective cohort study of such children. MATERIALS AND METHODS: We recruited prospectively child volunteers between 6 and 13 years of age with acute respiratory infections present for fewer than 10 days. Nasal middle meatal bacterial culture was taken with a rigid endoscope at enrollment and again after 3 weeks and evaluated for presence or absence of 3 potential pathogens: S. pneumoniae, H. influenzae and M. catarrhalis. The subsequent persistence of acute symptoms (nasal discharge: clear/colored, nasal obstruction and cough) was determined by means of a diary. Viral etiology was studied with polymerase chain reaction methods. RESULTS: The 82 children had had symptoms for an average of 4 days (range, 1-10) at entry, and viruses were detected in 54% (39 of 72). The endoscopic procedure and bacteriologic sampling succeeded in all cases. Thirty-eight children (46%) had at least 1 of the 3 pathogens in the middle meatus specimen. The children with nasal pathogens present at entry had a significantly longer mean duration of symptoms than those with nonpathogenic bacteria (difference, 3.6 days; 95% confidence interval, 0.7-6.5; P = 0.025). The effect remained significant after adjustment for age, sex, allergic symptoms and the presence of virus (adjusted relative hazard of delayed recovery, 2.0; 95% confidence interval, 1.1-3.6). CONCLUSIONS: We found that the use of endoscopic swab culture sampling from the nasal middle meatus is well-tolerated by children older than 6 years of age and that it can be useful in selected situations to determine pathogenic bacteria in the culture of these specimens.

Cefuroxime axetil versus placebo for children with acute respiratory infection and imaging evidence of sinusitis: a randomized, controlled trial.

AIM: To evaluate the efficacy of antibiotic treatment in children who presented in medical care with respiratory infection and had imaging evidence of sinusitis. METHODS: Eighty-two children (4-10 y) with acute respiratory symptoms and ultrasonography findings suggestive of acute rhinosinusitis were enrolled in a randomized, double-blind trial. The sinus findings were confirmed with plain radiographs. The children received either cefuroxime axetil in 125-mg capsules twice a day for 10 d or placebo. Main outcome measures were complete cure in 2 wk and absence of prolonged symptoms or complications. RESULTS: A total of 72 children (88%) completed follow-up. The sinusitis findings in the ultrasound could be confirmed with plain radiographs in 65 of the 72 patients (90%). The proportion of children completely cured by day 14 was similar in both groups (difference 6%, 95% confidence interval -16% to 29%). Similarly, there was no significant difference in the proportions of children who escaped prolonged disease and complications between the groups (difference 7%, -9% to 24%). CONCLUSION: A 10-d course of cefuroxime axetil offered no clinical benefit to children with an acute respiratory illness and imaging evidence of acute sinusitis.

Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years. DESIGN: Randomised, double blind, controlled trial. SETTING: Oulu University Hospital, a tertiary centre in Finland. PARTICIPANTS: 180 children aged 10 months to 2 years with recurrent acute otitis media. INTERVENTION: Adenoidectomy, sulfafurazole (sulphisoxazole) 50 mg/kg body weight, given once a day for six months or placebo. Follow up lasted for two years, during which time all symptoms and episodes of acute otitis media were recorded. MAIN OUTCOME MEASURES: Intervention failure (two episodes in two months or three in six months or persistent effusion) during follow up, number of episodes of acute otitis media, number of visits to a doctor because of any infection, and antibiotic prescriptions Number of prescriptions, and days with symptoms of respiratory infection. RESULTS: Compared with placebo, interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups (at six months the differences in risk were 10% (95% confidence interval -9% to 29%) and 18% (-2% to 38%), respectively). No significant differences were observed between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection. CONCLUSIONS: Adenoidectomy, as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media, is not effective in preventing further episodes. It cannot be recommended as the primary method of prophylaxis.

Paranasal sinus findings in children during respiratory infection evaluated with magnetic resonance imaging.

OBJECTIVE: The spreading of acute respiratory infection into the paranasal sinuses in children is poorly defined. The main objective of this study was to evaluate the frequency and spontaneous resolution of paranasal sinus abnormalities in children with acute respiratory infection using magnetic resonance imaging (MRI). METHODS: We examined 60 children with MRI (mean age: 5.7 years) with symptoms of acute respiratory infection. Twenty-six children with major abnormalities in the first MRI scan had a follow-up MRI taken 2 weeks later. RESULTS: The children had had symptoms of uncomplicated acute respiratory infection for an average of 6 days before the first examination (mean duration: 6.5; standard deviation: 3.0). Approximately 60% of the children had major abnormalities in their maxillary and ethmoidal sinuses, 35% in the sphenoidal sinuses, and 18% in the frontal sinuses. The most common abnormal finding was mucosal swelling. The mean overall MRI scores correlated significantly with the symptom scores (r(s) = 0.3). Of the individual symptoms, nasal obstruction, nasal discharge, and fever were significantly related to the MRI scores. Among the 26 children with major abnormalities in the first MRI, the findings subsequently improved significantly (mean [standard deviation] score: 12.7 [5.6] to 5.7 [5.2]), irrespective of the resolution of symptoms. CONCLUSIONS: These observations indicate that acute respiratory infection mostly spreads into the paranasal sinuses of children in the form of mucosal edema and that these abnormalities tend to resolve spontaneously without antimicrobial treatment.