A prospective study of the adverse effects of midazolam on withdrawal in critically ill children

Acta Paediatr. 1994 Nov;83(11):1194-9. doi: 10.1111/j.1651-2227.1994.tb18280.x.


Fifty-three critically ill infants and children received midazolam as sedation in a regional intensive care unit. Assessment of the level of sedation was carried out at regular intervals on withdrawal of midazolam. Forty-nine patients were fully alert within 4 h of midazolam being stopped. Four patients took from 6 h to 1 week to become fully alert. Four patients had abnormal behaviour highly suggestive of midazolam withdrawal. The onset of abnormal behaviour was within 12 h of discontinuation of midazolam. The duration of the abnormal behaviour ranged from 3 h to 1 week. One child had a paradoxical reaction to midazolam. The overall incidence of adverse effects to midazolam in the patients studied was 17%. No adverse effects were observed in infants; all adverse effects were observed in children. We have shown that it is possible to prospectively study the toxicity of sedatives in critically ill infants and children.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Child Behavior / drug effects
  • Child, Preschool
  • Critical Illness / therapy
  • Hallucinations / chemically induced
  • Humans
  • Incidence
  • Infant
  • Infant, Newborn
  • Midazolam / adverse effects*
  • Neurologic Examination
  • Prospective Studies
  • Risk Factors
  • Sleep Stages / drug effects
  • Substance Withdrawal Syndrome / diagnosis
  • Substance Withdrawal Syndrome / etiology*


  • Midazolam