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Abstract
We performed a prospective, randomized, double-blind, placebo-controlled clinical
trial of dicyclomine hydrochloride using specific diagnostic criteria for infantile
colic: spells of unexplained irritability, agitation, fussiness or crying lasting
greater than or equal to 3 hours/day, occurring greater than or equal to 3 days/week,
and continuing for greater than or equal to 3 weeks. Dicyclomine eliminated colic
in 15 of 24 (63%) infants, whereas placebo was effective in six of 24 (25%) (corrected
X2 = 5.42, P = 0.02). The study also addressed the hypothesis that parental distress
caused by infantile colic affects subsequent temperament and sleep patterns. The data
fail to document easier temperaments or longer sleep durations at 4 months in infants
whose colic ceased during treatment.