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Gabapentin versus dexchlorpheniramine in the treatment of uremic pruritus in hemodialysis patients: a double-blind randomized controlled trial

Grant number: 14/07278-7
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): January 01, 2015
Effective date (End): October 31, 2015
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Luciana Patrícia Fernandes Abbade
Grantee:Vitoria Gandur Pigari
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Dialysis is required in advanced chronic kidney disease. However, after its inception, many patients report symptoms such as uremic pruritus. It is observed in 22-90% of patients and manifests in different ways, which can interfere significantly in quality of life. Skin hydration alone is not often effective and systemic therapy is required for relief. Dexchlorpheniramine is a drug with wide clinical use which is administered when there are complaints about uremic pruritus, although the results are limited. More recently, other drugs, including gabapentin have been used. The objective of this study is to compare the efficacy and safety of gabapentin versus dexchlorpheniramine treatment of pruritus in hemodialysis patients. Method: A double-blind randomized controlled trial, longitudinal follow-up. Sixty patients in hemodialysis with persistent itchy skin will be enrolled. Quality of life questionnaire will be applied in Dermatology - DLQI and the intensity of pruritus will be analyzed by Visual Analog Scale - VAS. Initially Cold Cream will be used for 15 days. After, DLQI and VAS will be applied again. Patients with persistent itching of any intensity will be randomized to receive gabapentin or dexchlorpheniramine for 21 days, and at the end DLQI and VAS will be reapplied. Statistical analysis will be performed by intention to treat. Categorical variables are represented by percentages and the continuous ones by means and standard deviations or medians and quartiles (p25-p75). A longitudinal comparison of scores among patients, after both periods, will be performed by generalized linear mixed effects model. Data analysis will be performed using SPSS 20.0 software, considering significant p value <0.05.