Safety of methylphenidate following traumatic brain injury: impact on vital signs and side-effects during inpatient rehabilitation.
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 These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate.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).
Willmott
Catherine
C
Psychology Department, School of Psychology, Psychiatry & Psychological Medicine, Monash University, Clayton, VIC, Australia.
Ponsford
Jennie
J
Olver
John
J
Ponsford
Michael
M
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
D000697:Central Nervous System Stimulants; D008774:Methylphenidate