Cockcroft 2009.
| Methods | A comparative cohort study of sleepiness in ADHD children treated with methylphenidate compared to methylphenidate‐naïve | |
| Participants | Number of patients screened: not stated Number of participants included: 30 Number included as cases: methylphenidate (n = 12), methylphenidate naïve (n = 11) Number followed up in each arm: methylphenidate: 12 and methylphenidate naïve: 11 Number of withdrawals: 7 in the medication group were excluded because they were taking another medication, or matches with unmedicated children could be not be made Diagnosis of ADHD: DSM‐IV‐TR (subtype: not stated) Age range: 6.4‐12.7 years old IQ: normal Sex: 16 male, 7 female Methylphenidate‐naïve: 11 Ethnicity: not stated Country: South Africa Comorbidity: not stated Comedication: no Sociodemographics: not stated Inclusion criteria: Children in grades 1 through 6 from 3 South African Gauteng Department of Education (GDE) remedial primary schools ADHD diagnosis according to DSM‐IV‐TR Exclusion criteria: Children taking medications other than methylphenidate |
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| Interventions | Methylphenidate type: immediate release Methylphenidate dosage: not known Administration schedule: twice daily, morning and lunchtime Duration of intervention: 1 day Treatment compliance: not stated |
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| Outcomes |
Non‐serious adverse events: Parental questionnaire: formulated by the authors and rated at 2 time points during the day, between 1:00 pm and 3:00 pm and between 5:00 pm and 7:00 pm. Included the child's sleep habits, sleep patterns, total sleep time, sleep latency, night time arousals, daytime naps and comments regarding daytime sleepiness in the children from appropriate adults, as well as symptoms and signs of the common sleep disorders as delineated in the DSM‐IV. It also included a visual analogue scale anchored at 'not at all sleepy' to 'very sleepy' on which the parents were requested to rate their children's general levels of sleepiness Wits Faces Sleepiness: a subjective, pictorial scale designed specifically for children which consists of 5 cartoon faces depicting increasing levels of sleepiness. Rated at 8:30 am and 1:00 pm |
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| Notes | Sample calculation: not stated Ethics approval: approved by the Committee for Research on Human Subjects of the University of Witwatersrand Vested interest/funding/authors' affiliations: not stated Key conclusions of the study authors: in a group of children with ADHD taking methylphenidate, there was a significant increase in sleepiness a few hours after taking the medication, which may then have a significant impact on their learning. The data also imply that part of the mechanism of action of methylphenidate effects in these children may be by reduction of daytime sleepiness Comments from the study authors: it is highly recommended that school‐aged children diagnosed with ADHD be routinely screened for daytime sleepiness. Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental information regarding IQ, duration of study and methylphenidate dosage received through personal email correspondence with the authors in October 2013 and January 2014 (Cockcroft 2014 [pers comm]) |
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