Driving ability after acute and sub-chronic administration of levocetirizine and diphenhydramine: a randomized, double-blind, placebo-controlled trial.
Psychopharmacology (Berl)
; 169(1): 84-90, 2003 Aug.
Article
em En
| MEDLINE
| ID: mdl-12721777
ABSTRACT
RATIONALE Sedation following antihistamine use poses a danger to ambulant patients involved in daily activities such as driving. OBJECTIVE:
To investigate effects of levocetirizine (5 mg), diphenhydramine (50 mg), and placebo on driving ability during normal traffic.METHODS:
Forty-eight healthy volunteers participated in a double-blind, placebo-controlled, randomized clinical trial. Treatments were administrated on days 1, 2, 3 and 4, exactly 1.5 h before the start of the standardized driving test (performed on day 1 and day 4). In the standardized driving test, subjects were instructed to drive with a steady lateral position, while maintaining a constant speed (95 km/h). Primary parameter was the standard deviation of lateral position (SDLP; cm). Statistical analyses were performed separately for day 1 and day 4, using analysis of variance and an equivalence test. Equivalence to placebo was evidenced if the 95% confidence interval lay between -2.6 cm and +2.6 cm.RESULTS:
SDLP after levocetirizine was equivalent to placebo on both day 1 (-0.66 cm; +1.12 cm) and day 4 (-0.37 cm; +1.28 cm). In contrast, SDLP after diphenhydramine differed significantly from placebo on both day 1 ( P<0.0001) and day 4 ( P<0.0003). On day 1, the 95% confidence interval of diphenhydramine (+1.85 cm; +3.63 cm) was partially above the upper equivalence limit (+2.6 cm), indicating clinically relevant driving impairment. On day 4, however, the 95% confidence interval of diphenhydramine (+0.74 cm; +2.38 cm) was contained within the acceptance range.CONCLUSION:
In contrast to diphenhydramine, driving performance was not significantly affected while using 5 mg levocetirizine once daily.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperazinas
/
Condução de Veículo
/
Cetirizina
/
Difenidramina
/
Antagonistas dos Receptores Histamínicos H1
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Psychopharmacology (Berl)
Ano de publicação:
2003
Tipo de documento:
Article
País de afiliação:
Holanda