Antihistamines used to put young children sleep was found ineffective – researchers from Georgetown University Medical Center reports//.
Study suggested that children (under age 2) who received diphenhydramine drug showed no benefits from its effectiveness.
In fact, the national study, conducted by researchers from Georgetown University Medical Center and published in the July issue of Archives of Pediatrics & Adolescent Medicine, found that the drug appeared to perform worse than a placebo agent. Only 1 out of 22 children showed improvement in sleeping after using diphenhydramine compared to 3 in 22 children who used a placebo. The drug, an antihistamine, is available over-the-counter in generic forms or as the name-brand drug, Benadryl?.
Because of diphenhydramine's obvious lack of effectiveness, the clinical trial's Data Safety Monitoring Board shut down the study early, says lead author, Dan Merenstein, M.D., an assistant professor in the Department of Family Medicine at Georgetown.
‘This is a small study, but one with big implications, because it is looking at the effectiveness of a widely used drug that has not been examined for infant and toddler use,’ says Merenstein. Half of pediatricians recommend use of diphenhydramine, according to surveys, and many child-rearing books offer the same advice, ‘but because the drug works as a sleep aide for some adults, we pretend it works for everyone,’ he says.
Merenstein cautions that a larger study is needed to definitively prove that diphenhydramine doesn't work as thought in young children, but adds, ‘At this point I would advise parents to think about different methods to help a child sleep,’ Merenstein says.
Researchers at Johns Hopkins University, Virginia Fairfax University, and the University of Hawaii worked with Merenstein on the study, which he conducted at Johns Hopkins before coming to Georgetown.
The clinical trial, known as TIRED (TriPage: 1 2 Related medicine news :1
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