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Agitation as adverse drug reaction of doxapram in preterm neonates: prevalence and potential risk factors Background Apnea of prematurity (AOP) is a common complication in premature neonates. AOP can be treated with methylxanthines (e.g. caffeine) and maximal non-invasive ventilation. If this treatment does not suffice, doxapram can be added. Doxapram is used off-label in preterm neonates and evidence on efficacy and safety of its use is limited. Objective This research aimed to investigate the prevalence of agitation as possible adverse drug reaction (ADR) of doxapram treatment in preterm neonates. The secondary aim was to identify risk-factors for occurrence of this ADR. Design All patients born < 32 weeks of gestation that were treated with doxapram between December 2013 and May 2017 on the neonatal intensive care unit (NICU) of the Erasmus University Medical Center in Rotterdam were eligible for inclusion. All relevant demographic data and the numeric rating scale (NRS) agitation of the included patients were collected retrospectively. An event of agitation was defined as an NRS agitation of ≥ 4. Causality was formally assessed by a pharmacist and clinician using an adjusted version of Kramer's algorithm. Prevalence was calculated by dividing all patients with a causally related event of agitation by the total number of patients. Associations of potential risk factors with agitation as an ADR of doxapram were investigated by performing univariable and multivariable logistic regression. Results 119 patients were included. Prevalence of agitation as ADR of doxapram was 17.6%. The male sex was significantly associated with agitation as ADR of doxapram (odds ratio [OR] = 4.5; 95% confidence interval [CI] = 1.2-16.3). None of the other potential risk factors was associated with agitation as an ADR of doxapram. Conclusion The prevalence of agitation as ADR of doxapram in premature neonates was 17.6% and the male sex was significantly associated with the occurrence of agitation. Extra attention towards agitation as possible ADR of doxapram treatment in preterm neonates is needed.

Agitation as adverse drug reaction of doxapram in preterm neonates: prevalence and potential risk factors Background Apnea of prematurity (AOP) is a common complication in premature neonates. AOP can be treated with methylxanthines (e.g. caffeine) and maximal non-invasive ventilation. If this treatment does not suffice, doxapram can be added. Doxapram is used off-label in preterm neonates and evidence on efficacy and safety of its use is limited. Objective This research aimed to investigate the prevalence of agitation as possible adverse drug reaction (ADR) of doxapram treatment in preterm neonates. The secondary aim was to identify risk-factors for occurrence of this ADR. Design All patients born < 32 weeks of gestation that were treated with doxapram between December 2013 and May 2017 on the neonatal intensive care unit (NICU) of the Erasmus University Medical Center in Rotterdam were eligible for inclusion. All relevant demographic data and the numeric rating scale (NRS) agitation of the included patients were collected retrospectively. An event of agitation was defined as an NRS agitation of ≥ 4. Causality was formally assessed by a pharmacist and clinician using an adjusted version of Kramer's algorithm. Prevalence was calculated by dividing all patients with a causally related event of agitation by the total number of patients. Associations of potential risk factors with agitation as an ADR of doxapram were investigated by performing univariable and multivariable logistic regression. Results 119 patients were included. Prevalence of agitation as ADR of doxapram was 17.6%. The male sex was significantly associated with agitation as ADR of doxapram (odds ratio [OR] = 4.5; 95% confidence interval [CI] = 1.2-16.3). None of the other potential risk factors was associated with agitation as an ADR of doxapram. Conclusion The prevalence of agitation as ADR of doxapram in premature neonates was 17.6% and the male sex was significantly associated with the occurrence of agitation. Extra attention towards agitation as possible ADR of doxapram treatment in preterm neonates is needed.