Table K.6.6Evidence profile for oral baclofen compared with placebo in children with spasticity of different severities; adverse effects

Quality assessmentSummary of findings
No. of patientsEffectQuality
No. of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsBaclofenPlaceboRelative

(95% CI)
Absolute
Adverse effects
1 study (Milla 1977)randomised trialsserious1no serious inconsistencyno serious indirectnessserious2none5/2030/20RR = 11 (0.65 to 186.62)*-Low
Adverse effects (parental reports)
1 study (McKinlay 1980)randomised trialsserious4no serious inconsistencyno serious indirectnessserious5none8/2061/20RR = 8 (1.1 to 58.19)*35 more per 100 (from 1 more to 100 more)*Low
Drowsiness (therapist and teacher reports)
1 study (McKinlay 1980)randomised trialsserious4no serious inconsistencyno serious indirectnessserious5none12/200/20RR = 25 (1.58 to 395.48)*7-Low
Adverse effects
1 study (Scheinberg 2006)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious2none6/1584/159RR = 1.5 (0.53 to 4.26)*13 more per 100 (from 13 fewer to 87 more)*Moderate

CI confidence interval, RR relative risk

*

Calculated by the NCC-WCH

1

No washout period, allocation concealment unclear

2

Total number of events less than 300, the 95% confidence interval includes no effect and is wide

3

Children experienced adverse effects associated with baclofen during the initial dose finding period. 4/5 children were younger than 7 years and weighed less than 19 kg and in all five children symptoms disappeared a few days after stopping treatment. One child experienced hypotonia alone, two children experienced sedation alone, and two children experienced both adverse effects. No adverse reports were reported with stepped re-introduction of baclofen from a starting dose of 10mg/day, in all but one child, who had athetosis (sedation and hypotonia experienced at 20mg/day, but child continued in study on a 10mg/day dose).

4

Allocation concealment unclear

5

Total number of events less than 300, the 95% confidence interval is wide

6

Side effects were reported by the parents of 9/20 children. One of these reports pertained to the placebo period and the remaining 8 to the baclofen treatment period. In 4 of the 8 children reduction of dose of baclofen relieved side effects. Overall, drowsiness (5), sickness (2), dizziness (2), nocturnal enuresis (2), absence states, query epileptiform (2) slurred speech (2) and weakness (1) were reported, although the side effects are not listed by treatment period.

7

The investigators report this as a statistically significant difference (p<0.001).

8

Adverse effects reported as lethargy (1), constipation (2), seizures (2), poor appetite (1), drowsiness (1)

9

Adverse effects reported as lethargy (1), constipation (2), seizures (1), hypotonia (1), difficulty passing urine (1)

From: Appendix K, GRADE tables

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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