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To construct a reliable and clinically practical instrument for monitoring opioids and benzodiazepine withdrawal symptoms in pediatric ICU patients.Instrument development.Intensive care unit in an academic children's hospital.79 patients up to age 16 years on intravenous midazolam and/or opioids for ≥5 days. An expert panel of 85 physicians and nurses rated clinical relevance of withdrawal symptoms.During drug weaning repeated observations were performed with a checklist of 24 withdrawal symptoms described in the literature.For 76 children, 932 observations were obtained within 24 h after decrease and/or discontinuation of midazolam or opioids. Most frequent symptoms were tachypnea, agitation, motor disturbance, diarrhea, fever, anxiety, sleep disturbance and hypertension (14.6–29.6%). Multidimensional scaling (MDS) was performed to detect the underlying empirical structure of co-occurrences of symptoms. An expert panel judged clinical relevance of each withdrawal symptom on a four-point scale ranging from ‘definitively so' to ‘definitively not'. Agitation, anxiety, inconsolable crying, increased muscle tension, tremors, tachycardia and sweating were considered relevant by 85–95% of the experts. On the basis of the MDS results and the experts' opinions, 15 symptoms were included in the final instrument.We are the first to develop an assessment tool for withdrawal symptoms in pediatric ICU patients on the basis of the underlying empirical structure of co-occurrences of withdrawal symptoms that experts considered relevant. Future studies need to define cut-off points and clarify psychometric issues.