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Efficacy and Safety
of Acetaminophen vs Ibuprofen for Treating Children’s
Pain or Fever
Objective: To summarize studies testing
the efficacy and safety of single-dose acetaminophen and
ibuprofen for treating children’s pain or fever.
Data Sources Reports were gathered by searching
computerized databases (from their inception through May
2002) and registries, relevant journals, and
bibliographies of key articles.
Study Selection Seventeen blinded, randomized
controlled trials with children (<18 years) receiving
either drug to treat fever or moderate to severe pain.
Data Extraction Under a fixed-effects model, outcome
measures for an initial single dose of ibuprofen vs
acetaminophen were the risk ratio for achieving more
than 50% of maximum pain relief, effect size for febrile
temperature reduction, and risk ratio for minor and
major harm.
Conclusions: In children, single doses of ibuprofen
(4-10 mg/kg) and acetaminophen (7-15 mg/kg) have similar
efficacy for relieving moderate to severe pain, and
similar safety as analgesics or antipyretics. Ibuprofen
(5-10 mg/kg) was a more effective antipyretic than
acetaminophen (10-15 mg/kg) at 2, 4, and 6 hours
posttreatment.
(Arch Pediatr Adolesc Med. 2004;158:521-526.)
Cough Syrups Are Not Superior to Placebo!
Diphenhydramine and dextromethorphan are not superior to
placebo in providing nocturnal symptom relief for
children with cough and sleep difficulty as a result of
an upper respiratory infection. Furthermore, the
medications given to children do not result in improved
quality of sleep for their parents when compared with
placebo. Each clinician should consider these findings,
the potential for adverse effects, and the individual
and cumulative costs of the drugs before recommending
them to families.
(PEDIATRICS Vol. 114 No. 1 July 2004, pp. e85-e90)
Extended-Interval Aminoglycoside for
Children: A Meta-analysis
There has been a long-standing debate regarding whether
aminoglycosides should be administered on a multiple
daily dosing (MDD) or once-daily dosing (ODD) schedule.
Several unique characteristics of the aminoglycosides
make ODD an attractive and possibly superior alternative
to MDD. These include concentration-dependent
bactericidal activity; postantibiotic effect, which
allows continued efficacy even when serum concentrations
fall below expected minimum inhibitory concentrations;
decreased risk of adaptive resistance; and diminished
accumulation in renal tubules and inner ear.
Results:
Efficacy: There was no significant difference between
ODD and MDD in the clinical failure rate, microbiologic
failure rate, and combined clinical or microbiologic
failure rates, but trends favored ODD consistently.
There was no between-study heterogeneity for any
outcome. Efficacy analysis of all trials indicating
either clinical or microbiologic failures demonstrated
pooled failure rates of 4.6% (23 of 501 cases) in the
ODD arms and 6.9% (34 of 494 cases) in the MDD arms.
Nephrotoxicity: There was no significant difference
between ODD and MDD in the primary nephrotoxicity
outcomes. Secondary nephrotoxicity outcomes were
significantly better with ODD.
Ototoxicity: There was no significant difference between
ODD and MDD in the primary ototoxicity outcomes.
Data Interpretation. Clinical failures were uncommon in
the pediatric trials, regardless of the regimen used. If
anything, fewer clinical failures tended to occur with
ODD. Moreover, we observed a trend toward decreased
bacteriologic failures.
Conclusions. Although single trials have been small, the
available randomized evidence supports the general
adoption of ODD of aminoglycosides in pediatric clinical
practice. This approach minimizes cost, simplifies
administration, and provides similar or even potentially
improved efficacy and safety, compared with MDD of these
drugs.
(PEDIATRICS Vol. 114 No. 1 July 2004, pp. e111-e118)
Early Infant Multivitamin Supplementation Is Associated
With Increased Risk for Food Allergy and Asthma
Dietary vitamins have potent immunomodulating effects in
vitro. Individual vitamins have been shown to skew T
cells toward either T-helper 1 or T-helper 2 phenotypic
classes, suggesting that they may participate in
inflammatory or allergic disease. With the exception of
antioxidant protection, there has been little study on
the effect of early vitamin supplementation on the
subsequent risk for asthma and allergic disease. The
objective of this study was to determine whether early
vitamin supplementation during infancy affects the risk
for asthma and allergic disease during early childhood.
The researchers in above study concluded that early
vitamin supplementation is associated with increased
risk for asthma in black children and food allergies in
exclusively formula-fed children. Additional study is
warranted to examine which components most strongly
contribute to this risk. (PEDIATRICS Vol. 114 No. 1 July
2004, pp. 27-32)
Combination Tx for Asthma Effective in Single Daily Dose
A single daily dose of fluticasone propionate/salmeterol
was safe and effective in asthma control, Dr. Paul
Dorinsky reported in a poster session during the annual
meeting of the American Academy of Allergy, Asthma, and
Immunology.
The combination of fluticasone and salmeterol (250 micro
g/50 micro g) was significantly better than placebo or
fluticasone alone in several measures, including the
change in predicted peak expiratory flow, the change in
asthma symptom scores, and the change in albuterol use,
reported Dr. Dorinsky of GlaxoSmithKine (Research
Triangle Park, N.C.).
Fluticasone/salmeterol (Advair Diskus) is approved for
twice-daily use, but the combination’s pharmacokinetic
properties and previous clinical studies suggest that
once-daily dosing may be possible. The more convenient
dosing regimen may facilitate improved patient
compliance.
The investigators reported the results of a large,
double-blind, placebo-controlled, parallel-group trial
on patients with asthma who required pharmacotherapy.
The 632 patients, aged 12 years or older, had suffered
from asthma for a mean of 19 years.
The patients administered a single dose of fluticasone/salmeterol,
fluticasone (250 ìg) alone, or placebo once a day in the
evening for 12 weeks.
Patients on fluticasone/salmeterol had a significantly
greater improvement in percent predicted a.m. and p.m.
peak expiratory flow (PEF) than did patients on
fluticasone alone or placebo. Over the course of the
study, patients on the combination had a 2.8% advantage
in p.m. PEF over those on fluticasone and a 5.1%
advantage over those on placebo. The corresponding
figures for a.m. PEF were 4.4% and 8.5%. All of those
differences were statistically significant. In both PEF
measures, fluticasone alone was significantly better
than placebo.
Compared with baseline, patients on fluticasone/salmeterol
used albuterol about 1.8 fewer times per day on average
during the trial. Patients on fluticasone alone used
their albuterol about 1.4 fewer times per day, and
patients on placebo used their albuterol about 0.4 fewer
times per day. Fluticasone/salmeterol and fluticasone
alone were both significantly better than placebo on
this measure, and fluticasone/salmeterol was also better
than fluticasone alone.
The investigators observed the same pattern when
comparing adjusted 24-hour asthma symptom scores, which
were graded on a 0 to 9 scale. Patients taking
fluticasone/salmeterol had an improvement of about 1.3
points, compared with a 1-point improvement in those on
fluticasone, and a 0.6-point improvement in those on
placebo.
All of the treatments were well tolerated with few
adverse events, and only 4 patients in the treatment
groups withdrew due to an asthma exacerbation, compared
with 13 in the placebo group.
Juvenile Recurrent Parotitis:
A New Method of Diagnosis and Treatment
Objective. Juvenile recurrent parotitis (JRP) is a
nonobstructive, nonsuppurative parotid inflammation in
young children. Causative factors, such as local
autoimmune manifestation, allergy, infection, and
genetic inheritance, have been suggested, but none of
them has been proved to date. Until now, treatment of
JRP was divided into conservative observation and
antibiotic treatment, and no preventive therapy was
available.
Methods. Twenty-six cases symptomatic JRP in children
were diagnosed and treated with a combined endoscopic
approach. Sialography and sialoendoscopy were performed
bilaterally in all children. The treatment modality was
composed of lavage, ductal dilation, and hydrocortisone
injection.
Results. Sialography showed multiple sialectasis in the
affected gland and in the contralateral one as well.
Dilations and strictures were noticed in the main duct,
and kinks could be identified in 31% of the glands. The
main endoscopic finding was a white appearance of the
ductal layer without the healthy blood vessel coverage.
Recurrence of the symptoms occurred in only 2 (8%)
children.
Conclusions. The endoscopic technique provides the
possibility of a correct diagnosis and treatment. In
this article, the researchers present a new treatment
modality of irrigation and dilation under direct vision
by endoscopically guided miniature surgical
instruments.(PEDIATRICS Vol. 114 No. 1 July 2004, pp.
9-12)
The Probiotic Effect of
Saccharomyces boulardii in a Pediatric Age Group
The aim of this study was to determine the efficacy of
S. boulardii in diarrhea associated with commonly used
antibiotics such as sulbactam-ampicillin (SAM) and
azithromycin (AZT). Four hundred and sixtysix patients
were assigned to four different groups as follows: group
1: 117 patients receiving SAM alone; group 2: 117
patients receiving SAM and S. boulardii; group 3: 105
patients receiving AZT alone; group 4: 127 patients
receiving AZT and S. boulardii. Antibiotic-associated
diarrhea was seen in 42 of the 222 patients (18.9 per
cent) receiving an antibiotic without the probiotic, and
in 14 of the 244 patients (5.7 per cent) who received
both the probiotic and the antibiotic (p < 0.05). In the
group receiving SAM where S. boulardii use was found to
be significant, the use of S. boulardii decreased the
diarrhea rate from 32.3 to 11.4 per cent in the 1-5
years age group (p < 0.05). This is a pioneering study
investigating combined antibiotic and probiotic use in
pediatric diarrhea patients.
(From Jr of Tropical Pediatrics, Volume 50, Issue 4,
August 2004: pp. 234-238 )
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