Table L.1

OutcomeTotalHoving 2007
Hoving 2009a
Hoving 2009b
(three publications)
Gilmartin 2000
Krach 2004
(two publications)
Awaad 2003
(one publication)
Number of participants who underwent the test11717 children and young people (all younger than 18 years)51 patientsa (aged 4-31.3 years; mean 10 years 3 months, median 11 years 2months)49 patientsa (aged 4-32 years; mean 13.09 years; standard deviation 7.49 years)
Number of single doses given1352363b49b
Number of positive test results at any given dosage (however ‘positive’ was defined by the study authors)114174849
Number of negative test results at any given dosage216 c15 d0
Number of adverse effects and participants involvedAdverse effects: 38

Patients: 26
Adverse effects: 9

Children affected: 8e
Adverse effects: 29 (7 during placebo)

Patients affected: 18 (4 during placebo)f
None reported
Number of complications and participants involvedComplications: 21

Patients: 18
Complications: 19

Children affected: 16g
Complications: 2

Children affected: 2h
None reported
Number of participants with a positive test who went on to have continuous pump-administered intrathecal baclofen1001744 i39 i
Number of participants with a negative test result who went on to have continuous pump-administered intrathecal baclofen0000
Number of participants with a positive test result who did not go on to have continuous pump-administered intrathecal baclofen and reasons given1002h10
Number of participants in whom the beneficial effects observed during testing were also observed during continuous pump-administered intrathecal baclofen treatment at 12 months (beneficial effects are based on Ashworth scores measured at both assessment times)751740k18l
Number of participants in whom continuous pump-administered intrathecal baclofen treatment was not effective due to baclofen not having an effect1001m
Number of participants with adverse effects or complications requiring explantation of pump and reason given7n03n

Reasons:

All developed infections of the pump pocket: 1 had a second pump re-implanted to complete study and the other 2 withdrew from study
4n

Reasons:

Meningitis=1

Infection = 2 (1 was a ‘pocket infection’, unclear about the other one)

Lack of effect, no clinical improvement: 1m
a

Including adults

b

Related to lack of response to a single-specific dose

c

The five children who required a higher of dose of intrathecal baclofen (ITB) were significantly older (p=0.037) and weighed more (p=0.007) than the 12 children who responded to a low dose. No significant differences were reported for sex, GMFCS, cerebral palsy type, or the use of oral baclofen. One child had a second hospital admission to receive a second dose because the first one caused apathy and, in an upright position, nausea and vomiting. This condition “impeded the observation of effects and side effects”

d

3 patients had a positive response to placebo. 10 did not have a positive response to the initial 50-μg baclofen dose, and 2 did not have a positive response to the second 75-μg baclofen dose (but responded to 100 μg later on)

e

7 children became slightly lethargic, including one who also experienced transient excessive hypotonia. One child experienced excessive perspiration of hands and feet

f

Nausea, vomiting and drowsiness were common effects reported during baclofen, but unclear how many children involved were affected by each symptom

g

14 children experienced symptoms of lowered cerebrospinal fluid (CSF) pressure (including lethargy, decreased appetite, dry mouth, dizziness, perspiration, pallor, nausea, vomiting, and headache - the last 4 symptoms appeared or increased only in an upright position); 3 children CSF leaked from the catheter connection (In one of these, the catheter connection was defective, so a new catheter had to be inserted; in the other two reconnection of the cap solved the problem); 1 child had radicular pain in his right leg postoperatively. The pain was completely resolved by retracting the catheter by 5cm; 1 child developed gastroenteritis (other children on the ward had gastroenteritis)

h

One patient developed meningitis and withdrew from study and 1 patient had intercurrent gastroenteritis and also withdrew from study

i

Age unclear

j

Reasons for this: 3 patients elected to use oral medications, 2 had ‘family issues’, 1 child's body size was ‘too small’, 1 child died ‘unrelated to baclofen trial’, 1 child had ‘medical issues’, 1 child underwent spinal fusion and 1 family decided not to undergo implant at the time of the study, reason not given

k

This was the total number of patients at the time. Unclear how many of them were children.

l

From the study it is clear that at least 18 of the patients who had the pump were children. We have data on effectiveness reported by age groups (<18 and >18) but it appears as if all the 39 patients had been followed up. However, previously the authors reported that 10/39 patients did not have all follow-up outcomes available. It is unclear how many of these were children.

m

Unclear if this patient was a child and also unclear if this was the same patient in which the pump had to be stopped after 5 months because of a change of behaviour owing to an increase in seizure activity

n

Unclear whether any of these patients were children

From: Appendix L, Benefits and harms of intrathecal baclofen

Cover of Spasticity in Children and Young People with Non-Progressive Brain Disorders
Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications.
NICE Clinical Guidelines, No. 145.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Jul.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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