Treatment of itch with naltrexon in patients with burns
- Conditions
- Pruritus, Burns, Naltrexone, TreatmentJeuk, Brandwonden, Naltrexon, Behandeling
- Registration Number
- NL-OMON27783
- Lead Sponsor
- G.I.J.M. Beerthuizen, M.D., Ph.D. Dept. of Surgery Martini HospitalP.O. box 300339700 RM GroningenThe NetherlandsT. Visser, Pharm.D.Dept. of PharmacyMartini HospitalP.O. box 300339700 RM GroningenThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Eligible for inclusion are patients:
1. with (almost) healed burns who have been admitted to the burn centre;
2. 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:
1. TBSA of more than 20%;
2. 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);
3. Acute hepatitis;
4. History of drug/alcohol abuse;
5. 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.
6. Pregnant;
7. Breast feeding ;
8. Having used opioids 10 days prior to the start of treatment;
9. Using itch medication other than the study medication and unwilling to stop;
10. Psychiatric disorder;
11. Other disease associated with itch (eg excema, atopic dermatitis, cholestatic pruritus);
12. 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
- Secondary Outcome Measures
Name Time Method