Utilizing combination intrathecal baclofen and analgesic medication to manage spasticity and pain in patients with pediatric-onset disability: Case series.

The study had no control group, so reported changes cannot be compared with what would have happened without the medication switch. The sample was small and heterogeneous, and all classified patients were GMFCS V and MACS 4-5, so results may not apply to children with milder or different conditions. Families or caregivers answered many survey questions because some patients could not respond independently, and recall bias may have influenced answers. The survey questions were not validated, and pain type was not characterized. Many patients also received oral medications, toxin injections, bracing, serial casting, or surgery, so the effect of the intrathecal combination cannot be separated from those treatments. Only eight of nine identified patients were assessed because one pump was removed for infection, and the study did not directly compare combination therapy with baclofen alone.

Do not read the reported improvements as proof that intrathecal baclofen plus bupivacaine, morphine, or clonidine caused them. The study had no comparison group, used a nonvalidated caregiver survey, and patients were also receiving oral medications, toxin injections, bracing, serial casting, or surgery, so the contribution of any single treatment cannot be separated.