Khajehpiri 2014.
Methods | A cohort study of methylphenidate use for 6 months | |
Participants | Number of participants screened: not stated Number of participants included: 71 Number of participants followed up: 71 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: mean 8.23, range: 4‐15 years old IQ: not stated Sex: 46 males (64.8%), 25 females (35.2%) Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Iran Comorbidity: epilepsy 11.2%, neonatal jaundice 25.4%, seizure 4.2%, respiratory disease 2.82%, Down syndrome 2.82%, urinary tract infection 1.41% Comedication: methylphenidate plus risperidone: 23 (32.4%), methylphenidate plus other medications: 8 (11.3%) Sociodemographics: not stated Inclusion criteria All children under methylphenidate treatment alone or with other agents attending a university‐affiliated psychology clinic were screened regarding all subjective and objective adverse drug reactions (ADRs) of methylphenidate No specific inclusion‐exclusion criteria regarding duration of methylphenidate treatment course, methylphenidate dose, and probable co‐administered medications for management of ADHD were used for patient selection |
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Interventions | Methylphenidate type: not stated Mean methylphenidate dosage/day: 20.5 (SD 9.6) mg (range 5‐40) Administration schedule: not stated Duration of intervention: < 1 month (2.8%) to ≥ 6 months (63.1%) Treatment compliance: 63.1% received methylphenidate for ≥ 6 months; 2.8% less than a month |
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Outcomes | Type of adverse event/reaction/effect: ADRs Measure method/instrument: face‐to‐face interview with patients or his/her parents at regular follow‐up office visits through a checklist of methylphenidate adverse reactions in relevant scientific literature and reviewing their brief office charts Serious adverse events: The WHO definition of a serious adverse reaction was used i.e. any adverse reaction resulting in death, life‐threatening situation, persistent or significant disability/incapacity, hospital admission, or prolonged hospital stay |
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Notes | Sample calculation: no Ethics approval: Tehran University Medical Ethics committee Funding/vested interest: not stated Key conclusions of the study authors: our data suggested that although methylphenidate related adverse reactions were common in children with ADHD, they were mainly mild and non‐serious Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no |