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PEDIATRICS Vol. 113 No. 2 February 2004, pp. e116-e121

ELECTRONIC ARTICLE

Central Nervous System Side Effects of First- and Second-Generation Antihistamines in School Children With Perennial Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Comparative Study

Kar Hui Ng, MBBS*, Daniel Chong, MBBS*, Chin Khoon Wong, MBBS, MMed{ddagger}, Hian Tat Ong, MBBS, MMed{ddagger}, Chien Yee Lee, MBBS, MRCP{ddagger}, Bee Wah Lee, MD, FRCP, FAAAI* and Lynette Pei-Chi Shek, MBBS, MRCP*

* Department of Paediatrics, National University of Singapore, Singapore
{ddagger} Department of Paediatrics, National University Hospital, Singapore

Objective. Allergic rhinitis is common and on the rise. Antihistamines are the mainstay of treatment and are the most commonly prescribed drugs in Singapore. Treatment-related sedation and its effect on cognition are a major concern. First- and second-generation antihistamines show varying degrees of sedation, but to date, objective studies in children are lacking. The objective of this study was to assess the sedating effect of cetirizine (second-generation antihistamine) and chlorpheniramine (first-generation antihistamine) compared with placebo using an objective neurophysiological test.

Methods. This was a prospective, double-blind, placebo-controlled, randomized, single-dose, 3-way crossover study. Twenty-four children aged 7 to 14 years with allergic rhinitis completed the study. All children were randomly allocated to medication sequences and received 3 different drugs on 3 different days, at least 1 week apart. The P300 event-related potential was used as an objective test of sedation. Subjective assessment was by a visual analog scale.

Results. Chlorpheniramine and cetirizine increased P300 latency when compared with baseline. No significant increase was obtained with placebo. The significant increase in P300 latency was not accompanied by significant change in subjective somnolence as measured by the visual analog scale.

Conclusion. We have shown that cetirizine has sedative properties in children. The lack of correlation between P300 latency and the visual analog scale indicates that sedation induced by these drugs may not be subjectively noted.

Key Words: sedation • cetirizine • chlorpheniramine • P300 event-related potential

Abbreviations: CNS, central nervous system • ERP, event-related potential • VAS, visual analog scale • Fz , frontal location • Cz, central location • Pz, parietal location • Tmax, time to peak plasma drug concentration

Received for publication May 28, 2003; Accepted Oct 6, 2003.


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