jeuk bij patienten met brandwonden itch pruritus
Conditions
Interventions
Patients will take either naltrexone or placebo for two weeks and are
randomised to start with one or the other. Before the 2 treatment periods a
baseline measurement of 7 days will be done. In betw
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible for inclusion are patients with (almost) healed burns who have been admitted to the burn centre , and are 18 years of age or older with itch 4-6 weeks postburn.
Exclusion criteria
Exclusion criteria: Patients will be excluded when meeting one of the following exclusion criteria: •TBSA of more than 20% •liver insufficiency (in this study that means more than 2 times the normal range of the liverenzymes: ASAT> 80 U/L and/or ALAT >80 U/L and/or AF > 250U/L and/or gamma GT >100U/L) •acute hepatitis •history of drug/alcohol abuse •known sensitivity for any of the following substances: naltrexonehydrochloride, lactose monohydrate, crospovidone, powder cellulose, microcrystalline cellulose, colloid silicon dioxide, magnesium stearate, hypromellose, macrogole 4000, Titanium dioxide (E171), Black iron oxide (E172), Red iron oxide (E172), Yellow iron oxide (E172), carboxymethylamylum sodium type A, precirole. •pregnant •breast feeding •having used opioids 10 days prior to the start of treatment •using itch medication other than the study medication and unwilling to stop •psychiatric disorder •other disease associated with itch (eg excema, atopic dermatitis, cholestatic pruritus) •insufficiently proficient in Dutch to give informed consent and/or fill out the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean itch intensity score at end point, defined as the mean of the last 7 diary entries while the patient is receiving study medication. The percentage change in itch intensity score from baseline is calculated as: 1- (mean itch intensity score end point / mean itch intensity score baseline)) x 100% | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional aspects of itch (e.g. frequency, duration), the effect of treatment as perceived by the patient, pain, and various aspects of anxiety and sleep. | — |
Countries
Netherlands
Outcome results
None listed