Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Pediatr. 2003 Aug;143(2):219-23.

Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux.

Author information

  • 1Centre for Paediatric and Adolesent Gastroenterology, Women's and Children's Hospital, North Adelaide, SA 5006, Australia. moored@wch.sa.gov.au

Abstract

OBJECTIVE:

To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis.

STUDY DESIGN:

Irritable infants (n=30) 3 to 12 months of age met the entry criteria of esophageal acid exposure >5% (n=22) and/or abnormal esophageal histology (n=15). They completed a 4-week, randomized, double-blind, placebo-controlled crossover trial of omeprazole. Cry/fuss diary (minutes/24 hours) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period.

RESULTS:

The reflux index fell significantly during omeprazole treatment compared with placebo (-8.9%+/-5.6%, -1.9%+/-2.0%, P<.001). Cry/fuss time decreased from baseline (267+/-119), regardless of treatment sequence (period 1, 203+/-99, P<.04; period 2, 188+/-121, P<.008). Visual analogue score decreased from baseline to period 2 (6.8+/-1.6, 4.8+/-2.9, P=.008). There was no significant difference for both outcome measures while taking either omeprazole or placebo.

CONCLUSIONS:

Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability. Irritability improved with time, regardless of treatment.

Comment in

PMID:
12970637
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk