trial of infant response to diphenhydramine (TIRED study)
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Introduction
Study characteristics:
- 44 children (age range, 6-15 months)
- randomized, placebo-controlled, multisite U.S. clinical trial
Treatment groups:
- 7-day observation period with no intervention
- diphenhydramine (1 mg/kg) vs placebo 30 minutes before bedtime on days 8-14
- sleep diaries for 28 days
Results:
- diphenhydramine did NOT
- speed sleep
- lessen nighttime awakening
- increase parental satisfaction
More general terms
References
- ↑ Merenstein D, Diener-West M, Halbower AC, Krist A, Rubin HR. The trial of infant response to diphenhydramine: the TIRED study--a randomized, controlled, patient-oriented trial. Arch Pediatr Adolesc Med. 2006 Jul;160(7):707-12. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16818836