title: Safety of methylphenidate following traumatic brain injury: impact on vital signs and side-effects during inpatient rehabilitation.
abstract: OBJECTIVE
  The aim of the present study was to evaluate the safety of methylphenidate administered during inpatient rehabilitation following traumatic brain injury.
  
  
  METHODS
  Forty inpatients with moderate-severe traumatic brain injury (mean 68.4 days post-injury) participated in a randomized, cross-over, double-blind, placebo-controlled trial of methylphenidate administered at a dose of 0.3 mg/kg body weight twice daily.
  
  
  RESULTS
  Methylphenidate administration resulted in a statistically significant increase in pulse of 12.3 beats/min (95% confidence interval (CI) 9.25-15.36), diastolic blood pressure of 4.1 mmHg (95% CI 2.11-6.10), and mean arterial pressure of 3.75 mmHg (95% CI 1.79-5.72). These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate. Blinding was successful. Significantly greater reporting of irritability of 0.14 points (95% CI 0.02-0.26), difficulty sleeping of 0.17 points (95% CI 0.02-0.31) and total side-effects of 0.68 points (95% CI 0.06-1.30) was associated with methylphenidate compared with placebo.
  
  
  CONCLUSIONS
  Methylphenidate given at 0.3 mg/kg body weight appears to be safe in the inpatient rehabilitation phase. This trial is registered with the Australian New Zealand Clinical Trials Registry (12607000503426).
authors: Psychology Department, School of Psychology, Psychiatry & Psychological Medicine, Monash University, Clayton, VIC, Australia.
authors: Catherine
authors: C
authors: Willmott
authors: Jennie
authors: J
authors: Ponsford
authors: John
authors: J
authors: Olver
authors: Michael
authors: M
authors: Ponsford
mesh_terms: D000293:Adolescent; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D001930:Brain Injuries / Q000503:physiopathology / Q000534:rehabilitation*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011674:Pulse; D012449:Safety; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate