Chronic Renal Insufficiency , hemodialysis, uremic pruritus.
Conditions
Interventions
Participants (n=71) with persistent itching, will be provided the Cold cream (topical product- intervention) with use of 2 times a day,in the whole body, for 15 days. After this period, the participan
n=30, intervention) or dexchlorpheniramine at a dose of 6mg (Group 2
n=30, active control group) two times per day, by 21 days. Both groups will receive orientation to take 1 tablet every 12 hours and received 2 bottles identified as "home" and "Dialysis". Bottle "hom
Drug
D27.505.954.444.075
D27.505.954.444.200
Sponsors
Faculdade de Medicina de Botucatu
Fundo de Apoio à Dermatologia de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the consent form; Age above 18 years, of both genders; chronic renal insufficiency stage 5 on hemodialysis for at least 3 months; persistent pruritus of any intensity that occurs at least three times per week with a duration of 30 days or more; no use of topical antipruritic medications and / or systemic at least one week before start of study
Exclusion criteria
Exclusion criteria: Chronic skin diseases (allergic, infectious and parasitic); Chronic liver disease; Internal malignant disease; Use of opioids, antihistamines or corticosteroids. the participants Will be discontinued if: withdrawal of consent; using other treatments for pruritus not recommended in this protocol and serious adverse events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Decreased of pruritus score, by VAS (Visual Analog Scale), and improving the quality of life measured by DLQI (Dermatology Life Quality Index) after treatment with gabapentin and dexclorfeniramina; The VAS and DLQI will be applied before treatment (T0), after treatment with emollient (after 15 days -T15) and after oral treatment with gabapentin or dexchlorpheniramine (after 36 days - T36) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Decreased of pruritus score, by VAS (Visual Analog Scale), and improving the quality of life measured by DLQI (Dermatology Life Quality Index) after treatment with emollient. 2.Assessment of adverse events The VAS and DLQI will be applied before treatment (T0), after treatment with emollient (15 days - T15) and after oral treatment with gabapentin or dexchlorpheniramine (36 days -T36). | — |
Countries
Brazil
Contacts
Public ContactLuciana Fernandes Abbade
Faculdade de Medicina de Botucatu
Outcome results
None listed