Aggregated n-of-1 trials of central nervous system stimulants versus placebo for paediatric traumatic brain injury – a pilot study

Nikles, Catherine J; McKinlay, Lynne; Mitchell, Geoffrey K; Carmont, Sue-Ann S; Senior, Hugh E; Waugh, Mary-Clare A; Epps, Adrienne; Schluter, Philip J; Lloyd, Owen T

doi:10.1186/1745-6215-15-54

Trials

Table 1 Demographic and injury characteristics of participants

From: Aggregated n-of-1 trials of central nervous system stimulants versus placebo for paediatric traumatic brain injury – a pilot study

Patient	Sex	Age	GCS	Severity	Age at injury	Time since injury	Completed trial?	Cause of TBI	History of ADHD	Medication	PTA (or why not)
						(years)	Y = yes
1	M	14	< 8	Severe	5 years	9	Y	Paed versus MVA^b	Reported 'no’	DEX 5 mg bd	Not done (age)
2	F	10	?	Severe	18 months	8	Y	NAI^a	Too young	Unknown	Not done (age)
3	M	13	3	Severe	9 years	4	Y	MVA	Concentration and learning difficulties; but no diagnosis	DEX 10 mg mane and lunch	Not available
4	F	11	6	Severe	6 years	5	Y	Paed versus MVA^b	Unknown	MPH 10 mg mane 5 mg lunch	34 days
5	M	16	10	Severe	12 years	4	Y	Fall (6 m)	Concentration and learning difficulties; but no diagnosis	MPH 30 mg mane	4 weeks
6	M	16	15	Moderate to severe	14 years	2	N	Bicycle (fall)	Reported 'no’	MPH LA	1 to 2 days
7	M	Approximately 13	< 8	Severe	9 years	Approx 5	N	Bicycle versus MVA	Pre-injury ADHD diagnosis and treatment (methylphenidate)	MPH	Not done (nonverbal)
8	M	15	?	Moderate	4 years	11	N	Paed versus MVA^b	Reported 'no’	MPH 10 mg am and lunch	Not available (likely not done)
8	M	15	?	Moderate	4 years	11	N	Paed versus MVA^b	Reported 'no’	MPH 10 mg am and lunch	Unconscious 10–15 minutes
9	F	13	5	Severe	6 years	7	N	NAI^a	No developmental concerns prior to injury	MPH 10 mg mane 15 mg lunch	Not available (likely not done)
9	F	13	5	Severe	6 years	7	N	NAI^a	No developmental concerns prior to injury	MPH 10 mg mane 15 mg lunch	Unconscious 10 to 15 minutes
10	F	8	11	Moderate	26 months	6	N	NAI^a	Too young	Concerta 36 mg	Not done (age)

Comp, completed trial; DEX, dexamphetamine; GCS, Glasgow Coma Scale; MPH, methylphenidate; MVA, motor vehicle accident; ^aNon-accidental injury; ^bPedestrian hit by motor vehicle; PTA, post-traumatic amnesia. Note 3 and 5 had reported exacerbation of concentration and learning difficulties post TBI.
Imaging
1. Computer tomography (CT) head (time of injury): fracture of the left ethmoid region as well as parenchymal haemorrhages in the right occipital region.
2. CT head (time of injury): injuries included bilateral subdural haematomas and bilateral retinal haemorrhages. There were no fractures associated with the injury.
3. CT (initial; reported): he had a right extradural haematoma and significant cerebral contusions including his frontal lobe.
4. CT scan (initial) showed a diastasis of the right occipito-temporal suture in addition to a minimally displaced base of skull fracture, no intracranial lesions and a probable fracture through the left TMJ articular fossa.
5. Comminuted and depressed skull fracture of the right parietal and frontal bones (transversing the skull at the base of the sphenoid), with multiple areas of contusion and haemorrhage in the right frontal and temporal lobes with midline shift and overall swelling of the right cerebral hemisphere with midline shift.
6. Left temporal fracture with left extradural haematoma and haemorrhagic contusions involving the frontal and temporal lobes.
7. Diffuse axonal injury, multiple contusions, cerebral oedema, uncal and tonsillar herniation and haemorrhages involving the left basal ganglia and left cerebellum.
8. Not done.
9. Large left subdural haematoma with associated cerebral oedema.
10. Left frontal subdural of 7 mm with 5 mm midline shift.

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ISSN: 1745-6215

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