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Introduction: Limited evidence exists regarding medication administration errors (MAEs) on general paediatric wards or associated risk factors exists. Objective: The aim of this study was to identify nurse, medication, and work-environment factors associated with MAEs among paediatric inpatients. Methods: This was a prospective, direct observational study of 298 nurses in a paediatric referral hospital in Sydney, Australia. Trained observers recorded details of 5137 doses prepared and administered to 1530 children between 07:00 h and 22:00 h on weekdays and weekends. Observation data were compared with medication charts to identify errors. Clinical errors, potential severity and actual harm were assessed. Nurse characteristics (e.g. age, sex, experience), medication type (route, high-risk medications, use of solvent/diluent), and work variables (e.g. time of administration, weekday/weekend, use of an electronic medication management system [eMM], presence of a parent/carer) were collected. Multivariable models assessed MAE risk factors for any error, errors by route, potentially serious errors, and errors involving high-risk medication or causing actual harm. Results: Errors occurred in 37.0% (n = 1899; 95% confidence interval [CI] 35.7–38.3) of administrations, 25.8% (n = 489; 95% CI 23.8–27.9) of which were rated as potentially serious. Intravenous infusions and injections had high error rates (64.7% [n = 514], 95% CI 61.3–68.0; and 77.4% [n = 188], 95% CI 71.7–82.2, respectively). For intravenous injections, 59.7% (95% CI 53.4–65.6) had potentially serious errors. No nurse characteristics were associated with MAEs. Intravenous route, early morning and weekend administrations, patient age ≥ 11 years, oral medications requiring solvents/diluents and eMM use were all significant risk factors. MAEs causing actual harm were 45% lower using an eMM compared with paper charts. Conclusion: Medication error prevention strategies should target intravenous administrations and not neglect older children in hospital. Attention to nurses' work environments, including improved design and integration of medication technologies, is warranted. [ABSTRACT FROM AUTHOR]