A double-blind randomized controlled trial of management of recurrent nosebleeds in children. Prospective double blind randomized clinical trial comparing 75% versus 95% silver nitrate cauterization in the management of idiopathic childhood epistaxis. Management of epistaxis in children. A prospective, single-blind, randomized controlled trial of antiseptic cream for recurrent epistaxis in childhood. A prospective, single-blind, randomized controlled trial of petroleum jelly/Vaseline for recurrent paediatric epistaxis. Frequency of surgery among children who have adenotonsillar hypertrophy and improve after treatment with nasal beclomethasone. Randomised placebo-controlled trial of inhaled sodium cromoglycate in 1-4-year-old children with moderate asthma. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS Trial: a randomized controlled trial. Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice.
To establish whether a treatment regimen of silver nitrate cautery and 4 weeks of antiseptic nasal cream is superior to antiseptic cream treatment alone in the management of pediatric epistaxis.
                Double-blind randomized controlled trial.
                Children with epistaxis and visible anterior septal vessels were invited to participate. Patients were randomized to receive treatment or control. Treatment patients received silver nitrate cautery, followed by antiseptic cream for 4 weeks. Control patients received sham cautery followed by antiseptic cream for 4 weeks.
                A total of 109 patients were randomized and results were available for 93 (85%). Of those receiving cautery, 21 (45.7%) of 46 had no bleeding in the 4 weeks before follow-up. Of those receiving only antiseptic cream 14 (29.8%) of 47 had no bleeding. (chi(2) = 2.49; P = 0.114). More children in the active treatment group had an improvement in their symptoms compared with controls (42 of 46; 91.3%) in the treatment group vs 33 of 47 (70.2%) controls (chi(2) = 6.626; P = 0.01; relative risk reduction = 71 percent, number needed to treat = 4.7).
                When using subjective improvement in symptoms as the outcome measure, silver nitrate cautery with antiseptic cream twice daily for 4 weeks appears to give a small but statistically significant benefit when compared to antiseptic cream alone. Primary outcome measure: to evaluate which concentration of silver nitrate cauterization was more efficacious in the management of idiopathic childhood epistaxis. Secondary outcome measures: to evaluate side effects and pain scores of the differing concentrations.
                Prospective double blind randomized clinical trial.
                All children 16 years of age or younger referred by the accident and emergency department or general practitioner, with recurrent idiopathic epistaxis, who met the inclusion criteria entered the trial. Patients were randomized to receive either the 75% or 95% silver nitrate cauterization. Patients were reviewed at two weeks and eight weeks post cauterization. Pain scores, side effects and success of each treatments were recorded at the follow up clinic.
                101 patients completed the trial. 52 patients were randomized to receive the 95% concentration, and 49 patients were randomized to receive the 75% cauterization. In the 75% concentration group, 98% of patients had total resolution of their symptoms at the eight-week follow up. Mean pain scores in this group was 1 out of 10. In the 95% group, 90% had total resolution of their symptoms at the eight-week follow up. Mean pain scores in this group was 5 out of 10. There was a statistical difference in efficacy and pain scores (0.01 and 0.001).
                We would recommend the use of 75% silver nitrate cauterization in the management of childhood epistaxis, it appears to be more efficacious, has fewer side effects and is better tolerated.
                Copyright © 2010. Published by Elsevier Ireland Ltd. A randomised clinical trial of antiseptic nasal carrier cream (Naseptin) and silver nitrate cautery in the treatment of epistaxis in children was carried out. Fifty-four percent responded to cautery with silver nitrate and 50% to treatment with Naseptin antiseptic carrier cream. There were 24 patients in each group. No statistically significant difference was observed between the groups when tested with the chi 2 test. We believe that the first line treatment of epistaxis in children should be the use of antiseptic nasal cream. Epistaxis is common in children. Trials show antiseptic cream is as effective as cautery, but it is not known whether either is better than no treatment. We wished to know the efficacy of cream in children with recurrent epistaxis. The design was a single-blind, prospective, randomized controlled trial set in the Otolaryngology clinic in a children's hospital. The participants were 103 children referred by their general practitioner for recurrent epistaxis. Excluded were those with suspected tumours, bleeding disorders or allergies to constituents of the cream. Referral letters were randomized to treatment and no treatment groups. Treatment was antiseptic cream to the nose twice daily for 4 weeks, which was prescribed by the general practitioner before clinic attendance. All children were given an appointment for 8 weeks after randomization. The main outcome measures were the proportion of children in each group with no epistaxis in the 4 weeks preceding clinic review. Complete data were available for 88 (85%) of the children. Of the treatment group, 26/47 (55%) had no epistaxis in the 4 weeks before the clinic appointment. Of the controls, 12/41 (29%) had no epistaxis over the 4 weeks. This is a relative risk reduction of 47% for persistent bleeding (95% CI 9-69%) and an absolute risk reduction of 26% (95% CI 12-40%), giving a number needed to treat of 3.8 (95% CI 2.5-8.5). We conclude that antiseptic cream is an effective treatment for recurrent epistaxis in children. The aim of the study was to determine if petroleum jelly was an effective treatment for paediatric epistaxis. A single-blind, prospective, randomized controlled trial was undertaken in an otolaryngology outpatient clinic of a paediatric hospital from March 2001 to March 2002. A total of 105 children referred with recurrent epistaxis were randomized into the study, 52 into the treatment arm and 53 into the control arm. Children in the treatment arm applied Vaseline twice a day bilaterally for 4 weeks and were monitored for any bleeds for the next 4 weeks. Children in the control arm were simply given an 8-week appointment and the number of bleeds were monitored for the 4 weeks prior to their appointment. The outcome measure was the proportion of children in each group without nosebleeds in the preceding 4 weeks. Both groups were equally distributed in age, duration of symptoms and duration of each bleed. Fourteen of 51 (27.5%) patients of the treatment arm and 18 of 53 (34%) of the control arm did not bleed in the 4 weeks before review (chi-square test, P = 0.472). It can be concluded that Vaseline alone confers no benefit over simple observation in recurrent childhood epistaxis. To describe the long-term outcome of a cohort of children with symptomatic adenotonsillar hypertrophy treated with aqueous nasal beclomethasone.
                The children enrolled completed a 4-week single-blind, saline solution controlled crossover study of aqueous beclomethasone (total: 400 micro g/d). In a 24-week open-label follow-on study, beclomethasone 200 micro g/d was offered to all patients. During a 100-week follow-up, the degree of nasal obstruction and the frequency of adenotonsillectomy were assessed.
                Fifty-three children of the 60 enrolled completed the study. After the 4-week crossover trial, the severity of nasal obstruction of 24 children (45%) significantly decreased during the use of nasal steroids, but no child improved when saline solution was used. At 24, 52, and 100 weeks, the 24 children who had initially improved showed a significant decrease of the severity of nasal obstruction and of the frequency of adenotonsillectomy (54% vs 83%) compared with the 29 children who had not responded after the initial steroidal therapy.
                Evidence from this study suggests that 45% of children with adenoidal hypertrophy improved after 2 weeks of steroidal therapy. Among these children, an additional 24-week treatment at a lower steroid dosage was associated with a significant 52- and 100-week clinical improvement and with reduction of adenotonsillectomy compared with children (55%) who had not responded after the initial 2-week steroidal therapy. Inhalation therapy with sodium cromoglycate is recommended as the first-line prophylactic treatment for moderate asthma in children. The availability of spacer devices with face-masks has extended the applicability of metered-dose inhalers to younger children. We studied the feasibility and effects of this therapy compared with placebo in children aged 1-4 years.
                218 children aged 1-4 years with moderate asthma were recruited through 151 general practitioners between March, 1995, and March, 1996. They were randomly assigned sodium cromoglycate (10 mg three times daily) or placebo, given by inhaler with spacer device and face-mask for 5 months. Rescue medication (ipratropium plus fenoterol aerosol) was available during the baseline period of 1 month and the intervention period. Parents completed a daily symptom-score list. The primary outcome measure was the proportion of symptom-free days in months 2 to 5. Analysis was by both intention to treat and on treatment.
                167 (77%) children completed the trial. 131 (78%) of these children used at least 80% of the recommended dose. Of the 51 children who stopped prematurely, 23 had difficulties with inhaled treatment. The mean proportion of symptom-free days for both groups was greater for the treatment period than for the baseline period (95% CI for mean difference 5.1 to 17.5 cromoglycate, 11.9 to 23.3 placebo). However there were no differences between the sodium cromoglycate and placebo groups in the proportion of symptom-free days (mean 65.7 [SD 25.3] vs 64.3 [24.5]%; 95% CI for difference -8.46 to 5.70) or in any other outcome measure.
                Our study in a general practice setting shows that inhalation therapy with a spacer device and face-mask is feasible in a majority of children below the age of 4 years. However, long-term prophylactic therapy with inhaled sodium cromoglycate is not more effective than placebo in this age-group. It is not known whether intranasal corticosteroids are beneficial to treat acute rhinosinusitis in patients with a history of chronic or recurrent sinus symptoms.
                To assess whether the addition of an intranasal corticosteroid to antibiotic therapy affects the speed and rate of recovery of such patients with acute rhinosinusitis.
                A double-blind, randomized, placebo-controlled multicenter trial of 95 patients (median age, 39 years) with a history of recurrent sinusitis or chronic rhinitis and evidence of acute infection by sinus radiograph or nasal endoscopy, which was conducted from October 1998 through April 2000 at 22 sites (12 primary care and 10 otolaryngology).
                Two puffs (total dose, 200 microgram) of fluticasone propionate (n = 47) or placebo nasal spray (n = 48) in each nostril once daily for 21 days; all received 2 puffs of xylometazoline hydrochloride in each nostril twice daily for 3 days and 250 mg of cefuroxime axetil twice daily for 10 days.
                Time to clinical success (patient reported cured or much improved) during telephone follow-up at 10, 21, and 56 days.
                A total of 88 patients (93%) completed follow-up. Patients recorded their symptoms, work assessment, and compliance during the 3-week treatment phase. Patients receiving fluticasone achieved a significantly higher rate of clinical success than patients receiving placebo (93.5% vs 73.9%; P =.009). Patients treated with fluticasone improved significantly more rapidly (median of 6.0 days to clinical success) vs patients in the placebo group (median of 9.5 days; P =.01).
                The addition of fluticasone to xylometazoline and antimicrobial therapy with cefuroxime improves clinical success rates and accelerates recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis. The treatment of persistent otitis media with effusion (OME) remains controversial, but this condition is the commonest reason for children to require ear, nose, and throat (ENT) surgery. Trials of antibiotics are inconclusive, are often weak methodologically, and have not been done in general practice. Our aim was a trial of an antibiotic for OME in such a population.
                433 children, aged 6 months to 6 years, with OME from 57 general practices entered a 3-month watchful waiting period. Of 223 (52%) with persistent bilateral OME, 162 were randomised double-blind to receive co-amoxiclav suspension (20 mg/kg amoxicillin, 5 mg/kg clavulanate potassium) or matching placebo, orally three times a day for 14 days. All cases also received xylometazoline 0.25% decongestant nosedrops thrice daily. Of the 61 not randomised, 13 children were referred to an ENT surgeon and parents refused consent in 48 cases. The main outcome measures were persistent OME in both ears and in one or both ears, as assessed clinically and by tympanometry. Analysis was by intention-to-treat.
                79 children in the treatment group and 70 in the placebo group were analysed for efficacy. 3 withdrew in the co-amoxiclav group (2 lost to follow-up, 1 due to side-effects); 6 withdrew in the placebo group (5 and 1, respectively). In addition, 4 tympanograms were uninterpretable in the controls. Compliance was over 90% in both groups. Persistent OME in both ears and in one or both ears were found at significantly lower rates in the co-amoxiclav group than in the controls at the 2-week follow-up: 53 vs 84% and 77 vs 93%, respectively. Odds ratios adjusted for sex, history of adenoidectomy, and upper respiratory tract infection at follow-up were 0.25 (95% CI 0.11, 0.58, p = 0.001) and 0.30 (0.10, 0.89, p = 0.03), respectively. Parents of children in the co-amoxiclav group reported significantly more side-effects than those of control children (44 vs 22%, p = 0.03). Side-effects were mostly gastrointestinal and mild.
                Our study in a general-practice setting confirmed the positive short-term effect of antibiotic treatment for persistent middle-ear infection. Before referral to an ENT surgeon, children with persistent OME presenting to general practitioners could be considered for such treatment, depending on the individual child and possible adverse sequelae.
The optimal management of children with recurrent idiopathic epistaxis is unknown, however if silver nitrate nasal cautery is undertaken 75% is preferable to 95% as it is more effective in the short term and causes less pain. High-quality randomised controlled trials comparing interventions either with placebo or no treatment, and with a follow-up period of at least a year, are needed to assess the relative merits of the various treatments currently in use.