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Safety of benzodiazepines in newborns
Eugene Ng1, Gil Klinger, Vibhuti Shah
1Department of Newborn and Developmental Paediatrics, Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. eugene.ng@swchcs.on.ca
Insights
Benzodiazepine use in infants was linked to adverse events like seizures and respiratory depression. Careful consideration of the benefit-risk balance is crucial for this vulnerable population.
Area of Science:
- Neonatal intensive care
- Pharmacology
- Pediatric medicine
Background:
- Benzodiazepines are commonly used for sedation and seizure control in neonatal intensive care units.
- Anecdotal evidence suggests potential serious adverse effects (AEs) in infants.
Purpose of the Study:
- To investigate the incidence of AEs associated with benzodiazepine administration in both preterm and full-term infants.
- To assess the safety profile of benzodiazepines in neonates.
Main Methods:
- A retrospective chart review was conducted on 63 infants who received benzodiazepines.
- Data were collected over a 16-month period for infants treated with lorazepam, midazolam, or both.
Main Results:
- 16% of infants experienced 14 documented adverse events, including seizures, hypotension, and respiratory depression.
- A probable association between benzodiazepine use and AEs was identified in 12 cases.
- Seizures required anticonvulsant therapy, and respiratory depression necessitated ventilatory support.
Conclusions:
- Benzodiazepine administration in infants is frequently associated with adverse events.
- Underlying medical conditions and concurrent drug use may contribute to these AEs.
- Judicious use of benzodiazepines is recommended in neonates until further benefit-risk studies are available.
Background:
Benzodiazepines are being used in neonatal intensive care units for sedation and control of seizures. However, anecdotal reports suggest that their use in infants may be associated with serious adverse effects (AEs).
Objective:
To determine the incidence of AEs from benzodiazepine use in preterm and full-term infants.
Methods:
Retrospective chart review of 63 infants who received benzodiazepines as a sedative or anticonvulsant over a 16-month period.
Results:
Mean +/- SD gestational age of the infants was 33.1 +/- 6.2 weeks, and birth weight was 2.3 +/- 1.2 kg. Median (range) postnatal age at commencement of drug administration was 19 (5-54) days. Forty-one infants received lorazepam, 8 received midazolam, and 14 received both. Ten (16%) of the infants had 14 documented adverse events: seizures (n = 6), hypotension (n = 5), and respiratory depression (n = 3). Using a validated adverse drug reaction probability scale, a probable association with benzodiazepine use was demonstrated in 12 of the AEs. Due to the retrospective nature of the data, a score for definite association was not attainable. Anticonvulsant administration was required for 4 of 6 infants and, in all cases of respiratory depression, ventilatory support was initiated or increased. Two cases of significant hypotension were treated with inotropes. There was no statistically significant correlation between AEs and benzodiazepine dose or concomitant use of inotropes or analgesics (morphine), although most infants had underlying medical conditions or received multiple drugs that may have predisposed them to experience AEs.
Conclusions:
Administration of benzodiazepines was frequently associated with AEs in full-term and preterm infants. It is possible that underlying illnesses and concomitant drug use predisposed these effects. Until the benefit-to-risk ratio is determined by further studies, judicious use of benzodiazepines is recommended in this vulnerable population.