Treatment of itch with naltrexone in patients with burns: an explorative, randomised, double blind, placebo-controlled, cross-over clinical trial
- Conditions
- jeuk bij patienten met brandwondenitchpruritus10014982
- Registration Number
- NL-OMON31113
- Lead Sponsor
- Martini Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean itch intensity score at end point, defined as the mean of the last 7 diary<br /><br>entries while the patient is receiving study medication.<br /><br>The percentage change in itch intensity score from baseline is calculated as:<br /><br>1- (mean itch intensity score end point / mean itch intensity score baseline))<br /><br>x 100%</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional aspects of itch (e.g. frequency, duration), the effect of treatment<br /><br>as perceived by the patient, pain, and various aspects of anxiety and sleep.</p><br>