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.
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.


CONCLUSIONS
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.
Ng
Kar Hui
KH
Department of Paediatrics, National University of Singapore, Singapore.
Chong
Daniel
D
Wong
Chin Khoon
CK
Ong
Hian Tat
HT
Lee
Chien Yee
CY
Lee
Bee Wah
BW
Shek
Lynette Pei-Chi
LP
D000293:Adolescent; D002490:Central Nervous System / Q000187:drug effects; D017332:Cetirizine / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002744:Chlorpheniramine / Q000009:adverse effects* / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D018913:Event-Related Potentials, P300 / Q000187:drug effects*; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D012890:Sleep / Q000187:drug effects
D006634:Histamine H1 Antagonists; D039563:Histamine H1 Antagonists, Non-Sedating; D002744:Chlorpheniramine; D017332:Cetirizine