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Biomedical subjects

J L Paradise

Publications and source records attributed to J L Paradise.

At least 19 recordsLinked to original sources
PubMed1997

Efficacy of Auralgan for treating ear pain in children with acute otitis media.

OBJECTIVE: To determine the efficacy of Auralgan otic solution (combination product of antipyrine, benzocaine, and glycerin) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media (AOM). DESIGN: Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were randomly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s) of the affected ear(s). All children were also treated with 15 mg/kg of acetaminophen in a single dose. Ear pain was assessed by means of 2 visual analog seales-a linear scale and a color scale-at study entry and 10, 20, and 30 minutes later (T0, T10, T20, and T30, respectively). Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score. A baseline ear pain score of at least 3 points was required for study entry. Four outcome measures regarding ear pain score at T10, T20, and T30 were used: (1) proportion of subjects who showed 50% reduction, (2) proportion of subjects who showed 25% reduction, (3) proportion of subjects who showed a 1 or more point reduction, and (4) mean score over time. SETTING: Primary care center and emergency department of a children's hospital. PARTICIPANTS: Fifty-four children aged 5 to 19 years with ear pain and AOM. RESULTS: The Auralgan and placebo groups were comparable regarding age, sex, race, laterality of AOM, and T0 ear pain score. By each of the 4 measures used, the response to treatment consistently favored the Auralgan group, but only at T30 were any differences statistically significant. CONCLUSION: In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes.

Acute Disease↗
PubMed1997

Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of amoxicillin/clavulanate potassium (Augmentin) for treatment of acute otitis media in children.

OBJECTIVE: To compare the safety and efficacy, in treating acute otitis media (AOM) in children, of a new formulation of amoxicillin/clavulanate potassium (Augmentin) oral suspension providing 45/6.4 mg/kg/day and administered twice daily (bid) for 5 and 10 days, respectively, with the safety and efficacy of the original formulation providing 40/10 mg/kg/day and administered three times daily (tid) for 10 days. STUDY DESIGN: Eight hundred sixty-eight children ages 2 months to 12 years with AOM were randomly assigned to one of the three treatment groups. Stringent criteria were used for the diagnosis of AOM and for determinations of "cure" and "improvement." Subjects were reexamined on Days 12 to 14 and 32 to 38. RESULTS: Among subjects whose treatment and follow-up conformed fully to protocol, the proportion of treatment successes (clinically cured or improved) on Days 12 to 14 was 78.8% (149 of 189) in the tid 10-day group, 86.5% (154 of 178) in the bid 10-day group and 71.1% (140 of 197) in the bid 5-day group. Corresponding values on Days 32 to 38 were 64.2% (95 of 148) in the tid 10-day group, 63.1% (94 of 149) in the bid 10-day group and 57.8% (93 of 161) in the bid 5-day group. None of the differences between the tid 10-day regimen and either of the 2 bid regimens were statistically significant, but the bid 10-day regimen was significantly more effective than the bid 5-day regimen in younger subjects. In the study population as a whole, results were similar to those in per protocol subjects. Overall the incidence of protocol-defined diarrhea was 26.7% (74 of 277) in the tid 10-day group, compared with 9.6% (27 of 280) in the bid 10-day group (P < 0.0001) and 8.7% (25 of 286) in the bid 5-day group (P < 0.0001). CONCLUSIONS: In comparison with the original formulation of Augmentin administered tid for 10 days in the treatment of AOM in children, the new formulation administered bid for 10 days provides at least equivalent efficacy and causes substantially less diarrhea. Administration for 5 days appears not to provide equivalent efficacy, but the difference appears limited to younger children and the margin of difference is small.

Acute Disease↗
PubMed1997

Otitis media in 2253 Pittsburgh-area infants: prevalence and risk factors during the first two years of life.

OBJECTIVE: As part of a long-term study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we set out to delineate the occurrence and course of otitis media during the first 2 years of life in a sociodemographically diverse population of infants, and to identify related risk factors. METHODS: We enrolled healthy infants by age 2 months who presented for primary care at one of two urban hospitals or one of two small town/rural and four suburban private pediatric practices. We intensively monitored the infants' middle-ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 2 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated infants for otitis media according to specified guidelines. RESULTS: We followed 2253 infants until age 2 years. The proportions developing > or = 1 episode of middle-ear effusion (MEE) between age 61 days (the starting point for data analysis) and ages 6, 12, and 24 months, respectively, were 47.8%, 78.9%, and 91.1%. Overall, the mean cumulative proportion of days with MEE was 20.4% in the first year of life and 16.6% in the second year of life. Tympanostomy-tube placement was performed on 1.8% and 4.2% of the infants during the first and second years of life, respectively. By every measure, the occurrence of MEE was highest among urban infants and lowest among suburban infants; these differences were greatest in the earliest months of life. Overall, unadjusted mean cumulative proportions of days with MEE were higher among boys than girls, higher among black than white infants, and higher among Medicaid than private health insurance enrollees. Cumulative proportions of days with MEE varied directly with the number of smokers in the household and with the number of other children to whom infants were exposed, whether at home or in day care, and varied inversely with birth weight, maternal age, level of maternal education, a socioeconomic index, and duration of breastfeeding. After adjustment, using multivariate analysis, the only variables that each remained independently and significantly related to the cumulative proportion of days with MEE were: during the first year of life, study site grouping, sex, the socioeconomic index, breastfeeding for > or = 4 months, the number of smokers in the household, and an index rating the degree of exposure to other children at home or in day care; and during the second year of life, sex, the socioeconomic index, and the child exposure index. The duration of breastfeeding and the degree of exposure to tobacco smoke contributed little to the explained variance; most was attributable to differences in the socioeconomic index and the child exposure index. CONCLUSIONS: Contrary to findings in many previous reports, the prevalence of otitis media during the first 2 years of life among lower-socioeconomic-status black infants appears to be as high as, if not higher than among lower-socioeconomic-status white infants, and certainly higher than among middle-class white infants. Among middle-class white infants the prevalence may also be higher than commonly assumed. The most important sociodemographic risk factors for otitis media appear to be low socioeconomic status and repeated exposure to large numbers of other children, whether at home or in day care.

Black People↗
PubMed1995

Developmental implications of early-life otitis media.

This symposium addressed possible relationships between early-life otitis media (OM) and various components of child development. The existence and nature of such relationships are of substantial theoretical and practical consequence. Particularly at issue are policies concerning optimal frequencies of examination and screening for middle-ear disease as well as the relative appropriateness of conservative vs. aggressive regimens of management.

Age Factors↗
PubMed1995

The adenoid as a key factor in upper airway infections.

The adenoids (and the nasopharynx) play a key role in the normal functioning and in various pathologies of the upper respiratory tract. In this paper the role of adenoidal pathology and the beneficial effect of adenoidectomy in some upper respiratory tract and facial anomalies and diseases are discussed; otitis media with effusion, recurrent acute otitis media, sinusitis, snoring and sleep apnea and abnormal patterns in the midface growth and development.

Adenoidectomy↗
PubMed1995

Treatment guidelines for otitis media: the need for breadth and flexibility.

The recent issuance of guidelines for the diagnosis and treatment of otitis media with effusion in young children is an effort to provide direction for the practitioner in managing this common condition. Although the guidelines may often prove helpful, practitioners will need to maintain some degree of flexibility in dealing with patients both with acute otitis media and with otitis media with effusion, based on specific patient-related and disease-related factors.

Acute Disease↗
PubMed1995

Managing otitis media: a time for change.

Given the increasing prevalence of multiply resistant pneumococcal infection and the heightened risks associated with antimicrobial usage, antimicrobial treatment of otitis media in children should be restricted generally to the extent possible without compromising individual children's well-being and without subjecting them to risks potentially greater than the risks associated with antimicrobial usage. Not infrequently the decisions required will be difficult and matters of judgment. However, in most cases the indications for initiating or prolonging antimicrobial treatment will be either straightforward, calling for a decision to proceed, or marginal, in which case the decision not to proceed should be clear.

Acute Disease↗
PubMed1994

Evidence in infants with cleft palate that breast milk protects against otitis media.

OBJECTIVE: Most infants with cleft palate suckle unproductively and require feeding by artificial means. Most also have unremitting otitis media accompanied by (usually) nonpurulent middle-ear effusion, a complication generally attributed to impaired eustachian tube ventilatory function. We observed two infants with cleft palate in whom one or both ears appeared effusion-free on more than one occasion, and who also were receiving or previously had received breast milk feedings. This prompted us to analyze the relation between middle-ear status and feeding mode in a large series of infants with cleft palate. Our objective was to determine whether in these infants the receipt of breast milk mitigated the otherwise virtually invariable development and continued presence of otitis media. METHODS: We reviewed and analyzed data concerning both feeding mode and the presence or absence of middle-ear effusion in 315 infants with cleft palate, as recorded systematically in the course of prospective studies at our Cleft Palate-Craniofacial Center. Analysis was limited to periods preceding the infants' receipt of tympanostomy-tube placement or palate repair, or their second birthday, whichever occurred first. RESULTS: Freedom from effusion in one or both ears was found at one or more visits in only seven (2.7%) of 261 infants fed cow's milk or soy formula exclusively, but in 17 (32%) of 54 infants fed breast milk exclusively or in part for varying periods (P < .0001). In virtually all instances, the breast milk had been harvested by the mother and fed to the infant via an artificial feeder. Baseline clinical and sociodemographic characteristics and surveillance in the two groups of infants were comparable. CONCLUSIONS: Artificially fed breast milk provides variable protection against the development of otitis media in infants with cleft palate. This finding supports the likelihood of a similarly protective effect of breast milk in noncleft infants. The finding also suggests strongly that in infants with cleft palate, impaired eustachian tube function is not the only pathogenetic factor in the infants' initial development of middle-ear effusion.

Breast Feeding↗
PubMed1992

Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion.

In a previous trial involving 109 children with chronic otitis media with effusion of at least a 2 months' duration that had been unresponsive to medical treatment, we compared the efficacy of myringotomy with tube insertion, myringotomy alone and no surgical intervention with regard to time with middle ear effusion, hearing status and other indices over a 3-year period. Because interpretation of the results was rendered difficult by certain complexities of study design, the present trial with a revised protocol was carried out in an additional group of 111 children. As in the previous trial, myringotomy with tube insertion resulted in less time with effusion and better hearing than did either myringotomy alone or no surgery. However, acute and chronic otorrhea and tympanic membrane perforation developed not uncommonly after tube insertion. Myringotomy alone offered no advantage over no surgery regarding the percent of time with effusion or the number of episodes of acute otitis media. Currently for children with long-standing middle ear effusion, we recommend either watchful waiting with periodic hearing assessment or myringotomy with tube insertion, individualizing the recommendation for each child.

Child↗
PubMed1992

Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial.

To determine the efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion in preventing recurrences of acute otitis media, we randomized 264 children 7 to 35 months of age who had a history of recurrent otitis media but were free of middle ear effusion to receive either amoxicillin prophylaxis, bilateral tympanostomy tube insertion or placebo. The average rate of new episodes per child year of either acute otitis media or otorrhea was 0.60 in the amoxicillin group, 1.08 in the placebo group and 1.02 in the tympanostomy tube group (amoxicillin vs. placebo, P less than 0.001; tubes vs. placebo, P = 0.25). The average proportion of time with otitis media of any type was 10.0% in the amoxicillin group, 15.0% in the placebo group and 6.6% in the tympanostomy tube group (amoxicillin vs. placebo, P = 0.03; tubes vs. placebo, P less than 0.001). At the 2-year end point, the rate of attrition was 42.2% in the amoxicillin group, 45.5% in the placebo group and 26.7% in the tympanostomy tube group. Adverse drug reactions occurred in 7.0% of the amoxicillin group and persistent tympanic membrane perforations developed in 3.9% of the tympanostomy tube group. The observed degree of efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion must be viewed in light of the fact that study subjects proved not to have been at as high risk for acute otitis media as had been anticipated and in view of the differential attrition rates.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1992

Antimicrobial prophylaxis for recurrent acute otitis media.

Antimicrobial prophylaxis for recurrent otitis media was first reported in 1960 in an uncontrolled study using a long-acting sulfonamide in Native American children younger than 11 years of age. In subsequent controlled studies using various antimicrobial drugs (primarily aminopenicillins or sulfonamides) subjects receiving prophylaxis continued to have episodes of acute otitis media, but at rates substantially lower than those of controls. More recently, prophylaxis has appeared effective in reducing the number of acute recurrences, but not the cumulative proportion of time with middle ear effusion that was present independent of such recurrences. Although questions remain about choice of drug, optimal dosage schedules, risk of untoward drug reactions, duration of use, and the risk of encouraging the emergence of resistant strains of pathogenic bacteria, antimicrobial prophylaxis currently appears to be the most logical first approach in the management of the child with recurrent otitis media.

Acute Disease↗