Table K.6.8Evidence profile for oral dantrolene compared with placebo in children with spasticity of different severities; tone assessment

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

(95% CI)
Absolute
Motor tone assessment
1 study (Haslam 1974)randomised trialsno serious limitationsno serious inconsistencyserious1serious2none593553-0.609 higher4Low
Scissoring
1 study (Haslam 1974)randomised trialsno serious limitationsno serious inconsistencyserious5serious2none593553-0.381 higher6Low
Incidence of spasms (child and parental reports of improvement)
1 study (Joynt 1980)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious7none3/110/9RR = 5.83 (0.34 to 100.03)*8-Moderate
Passive range of movement (PROM)
1 study (Haslam 1974)randomised trialsno serious limitationsno serious inconsistencyserious9serious2none593553-0.565 higher10Low
Spontaneous range of movement
1 study (Haslam 1974)randomised trialsno serious limitationsno serious inconsistencyserious11serious2none593553-0.522 higher12Low

CI confidence interval, RR relative risk

*

Calculated by the NCC-WCH

1

Assessments made using an eight point quantitative score (ranging from hypotonia -1 to hypertonia - 8) rather than a validated scoring system

2

Total population less than 400, 95% confidence interval not calculable.

3

No baseline or final values of assessment reported

4

Mean difference between dantrolene and placebo periods reported as p>0.05 (T-test for mean ΔD-ΔP)

5

Assessments made using an four point quantitative score (ranging from no scissoring -1 to marked - 4) rather than a validated scoring system

6

Mean difference between dantrolene and placebo periods reported as p<0.05 (T-test for mean ΔD-ΔP)

7

Total event rate less than 300, 95% confidence interval not calculable

8

p=0.089 reported

9

Assessments made using a seven point quantitative score (ranging from no restriction -1 to marked - 7) rather than a validated scoring system

10

Mean difference between dantrolene and placebo periods reported as p>0.05 (T-test for mean ΔD-ΔP)

11

Assessments made using a seven point quantitative score (ranging from no restriction -1 to marked - 7) rather than a validated scoring system

12

Mean difference between dantrolene and placebo periods reported as p>0.05 (T-test for mean ΔD-ΔP)

Calculated by the NCC-WCH

Assessments made using an eight point quantitative score (ranging from hypotonia -1 to hypertonia - 8) rather than a validated scoring system

Total population less than 400, 95% confidence interval not calculable.

No baseline or final values of assessment reported

Mean difference between dantrolene and placebo periods reported as p>0.05 (T-test for mean ΔD-ΔP)

Assessments made using an four point quantitative score (ranging from no scissoring -1 to marked - 4) rather than a validated scoring system

Mean difference between dantrolene and placebo periods reported as p<0.05 (T-test for mean ΔD-ΔP)

Total event rate less than 300, 95% confidence interval not calculable

p=0.089 reported

Assessments made using a seven point quantitative score (ranging from no restriction -1 to marked - 7) rather than a validated scoring system

Mean difference between dantrolene and placebo periods reported as p>0.05 (T-test for mean ΔD-ΔP)

Assessments made using a seven point quantitative score (ranging from no restriction -1 to marked - 7) rather than a validated scoring system

Mean difference between dantrolene and placebo periods reported as p>0.05 (T-test for mean ΔD-ΔP)

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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