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Arch Pediatr Adolesc Med. 2006 Jul;160(7):707-12.

The trial of infant response to diphenhydramine: the TIRED study--a randomized, controlled, patient-oriented trial.

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1
Robert Wood Johnson Clinical Scholars Program, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. djm23@georgetown.edu

Abstract

OBJECTIVE:

To determine if infants aged 6 to 15 months with frequent parent-reported nighttime awakenings require reduced parental aid during a week of diphenhydramine hydrochloride treatment and 2 and 4 weeks after its discontinuation.

DESIGN:

Double-blind, randomized, controlled clinical trial.

SETTING:

The study was conducted from May 1, 2004, through May 1, 2005; patients were recruited nationally.

PARTICIPANTS:

Forty-four participants aged 6 to 15 months.

INTERVENTIONS:

Placebo or diphenhydramine was administered in infants 30 minutes before anticipated bedtime.

MAIN OUTCOME MEASURES:

The primary outcome was dichotomous: a parental report of improvement in the number of night awakenings requiring parental assistance during the intervention week, which ended on day 14. Secondary outcomes were improved sleep during the 2 weeks before days 29 and 43, parental overall happiness with sleep, and improved sleep latency.

RESULTS:

On June 6, 2005, the data safety monitoring board voted unanimously to stop the trial early because of lack of effectiveness of diphenhydramine over placebo. Only 1 of 22 children receiving diphenhydramine showed improvement compared with 3 of 22 receiving placebo. To reach the a priori determined sample size and have a positive outcome (ie, rejecting the null hypothesis), the trial would have needed to enroll 16 more participants in each arm, with 15 of the 16 in the diphenhydramine group and 0 of 16 in the placebo group improving.

CONCLUSION:

During 1 week of therapy and at follow-up 2 and 4 weeks later, diphenhydramine was no more effective than placebo in reducing nighttime awakening or improving overall parental happiness with sleep for infants.

Comment in

PMID:
16818836
DOI:
10.1001/archpedi.160.7.707
[Indexed for MEDLINE]
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