Abstract | BACKGROUND: In 2006 there were 432,700 people in Australia who had acquired brain injury (ABI) with some limitation of activities; 90% of these were traumatic brain injuries (TBIs) and nearly a third sustained injury below age 15 years. One to four years post injury, 20% to 46% of children with traumatic brain injury (TBI) have clinically significant disorders of attention. There is controversy as to whether central nervous system ( CNS) stimulants can be an effective method of treating these.Objectives were to determine the efficacy of CNS stimulants for children with TBI, and to calculate the sample size for a larger trial using the Conners' 3 Parent Rating Scales Score as the primary endpoint. METHODS: Pilot series of aggregated prospective randomised, double-blind, n-of-1 trials of stimulant versus placebo within individual patients. SETTING: tertiary children's public hospital. PARTICIPANTS: ten children aged 6 to 16 years more than 12 months post TBI with attention, concentration and behavioral difficulties on stimulants. INTERVENTIONS: MAIN OUTCOME MEASURES: Conners 3 Parent (Conners 3-P) and Teacher (Conners 3-T) Rating Scales (Global Index), Behaviour Rating Inventory of Executive Function (BRIEF) and Eyberg Child Behaviour Inventory (ECBI). RESULTS: Five of ten patients completed the study. Data from 18 completed cycles from seven patients were analysed. The posterior mean difference between stimulant and placebo scores for the Conners 3-PS (Global Index) was 2.3 (SD 6.2; 95% credible region -1.0 to 6.1; posterior probability that this mean difference was greater than zero was 0.92), and for the Conners 3-T (Global Index) the posterior mean difference was 5.9 (SD 4.5; 95% credible region -3.1 to 14.9; posterior probability 0.93). Posterior mean differences suggest improvement in behaviour and executive function and a decrease in number and intensity of child behaviour problems when taking stimulants compared to placebo. Taken together these data are suggestive of a small benefit at group level. CONCLUSIONS: In this pilot study, there was sufficient evidence that stimulants may be useful in management of behavioral and cognitive sequelae following TBI, to warrant a larger trial. TRIAL REGISTRATION: he trial was registered with the Australian and New Zealand Clinical Trials Registry: registration number ACTRN12609000873224.
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Authors | Catherine J Nikles, Lynne McKinlay, Geoffrey K Mitchell, Sue-Ann S Carmont, Hugh E Senior, Mary-Clare A Waugh, Adrienne Epps, Philip J Schluter, Owen T Lloyd |
Journal | Trials
(Trials)
Vol. 15
Pg. 54
(Feb 13 2014)
ISSN: 1745-6215 [Electronic] England |
PMID | 24524676
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Central Nervous System Stimulants
- Methylphenidate
- Dextroamphetamine
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Topics |
- Adolescent
- Adolescent Behavior
(drug effects)
- Age Factors
- Attention
(drug effects)
- Attention Deficit Disorder with Hyperactivity
(diagnosis, drug therapy, etiology, physiopathology, psychology)
- Brain
(drug effects, physiopathology)
- Brain Injuries
(complications, diagnosis, physiopathology, psychology)
- Central Nervous System Stimulants
(administration & dosage, adverse effects)
- Child
- Child Behavior
(drug effects)
- Child, Preschool
- Cross-Over Studies
- Dextroamphetamine
(administration & dosage, adverse effects)
- Double-Blind Method
- Executive Function
(drug effects)
- Female
- Hospitals, Pediatric
- Hospitals, Public
- Humans
- Infant
- Male
- Methylphenidate
(administration & dosage, adverse effects)
- Pilot Projects
- Prospective Studies
- Queensland
- Tertiary Care Centers
- Time Factors
- Treatment Outcome
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