الدومبيردون و تطاول الفاصلة QTC عند الأطفال

الملخص EN

Background: Domperidone is considered as essential drug in the treatment plan of Gastroesophageal reflux disease (GERD) in children; The use of Domperidone has recently increased as asafe alternative of Metoclopramide and Cisapride; however, serious cardiac effects; QT interval prolongation and life-threatening ventricular tachyarrhythmias have been reported with Domperidone.

Therefore it was necessary to ensure the safety of its use in children, particularly infants and to study its impact on the QT interval.

Objective: To evaluate the effect of oral Domperidone use on corrected QT interval in infant (<1 year).

Methods & Materials: A prospective clinical study conducted on infants receiving oral Domperidone to treat Gastroesophageal reflux disease (GERD), who were attended in Children's Hospital- Damascus university-during one year period (December 2011-December 2012).

Electrocardiogram (ECG) was obtained for every infant just before and 3, 7 and 14 days after initiation of domperidone, and a continous ECG (Holter) was obtaind at the 7 and 14 days after initiation of Domperidone.

Results: The study included 20 infants, with gastroesophageal reflux, who were treated with oral Domperidone (0.25mg/kg/3times/day).

The mean weight at the onset of Domperidone treatment was (4400±1000)g, and mean age was (5±3.4)months.

Oral Domperidone was associated with QTc prolongation in children in our study of more than 450 milliseconds in 2 infants in our study(10%).

There was a difference in QTc interval between baseline QT interval, and QT interval was recorded at day 3,7 and 14 after the start of treatment.

The mean variation of the QTc interval (∆QTc) was (0.035-0.039-and 0.041 seconds) during the duration of study (after 3,7 and 14 days after the start of treatment with oral Domperidone) compared with the value of the QTc interval in every child before the treatment.

None of the children developed ventricular cardiac arrhythmia.

Conclusion: Oral Domperidone significantly (p<0.05) increased QT interval in children, however, but this increase Domperidone was below the level of clinical importance.However, additional data and larger studies are needed to give optimal advice regarding the safety of Domperidone treatment in infants and children.