Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?

Shaare Zedek Medical Center

Status and phase: Terminated; Phase 4

Conditions: Cerebral Palsy

Treatments: Drug: placebo + oral baclofen; Drug: oral baclofen + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00752934

59/08

Details and patient eligibility

About

Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and pain. In this study we will check if treatment with Baclofen reduces pain in disabled children with stiff muscles.

Enrollment: 20 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia

Exclusion criteria

• active epilepsy severe truncal hypotonia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

group a

Experimental group

Description:

Baclofen followed by Placebo

Treatment:

Drug: oral baclofen + placebo

group b

Experimental group

Description:

Placebo followed by Baclofen

Treatment:

Drug: placebo + oral baclofen