Treatment of itch with naltrexon in patients with burns
- Conditions
- BurnsInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN68179235
- Lead Sponsor
- Martini Hospital (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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. Who are 18 years of age or older with itch 4 - 6 weeks post burn
Patients will be excluded when meeting one of the following exclusion criteria:
1. Total Body Surface Area (TBSA) of more than 20%
2. Liver insufficiency (in this study that means more than two times the normal range of the liver enzymes: Aspartate Aminotransferase [ASAT] greater than 80 U/L and/or Alanine Aminotransferase [ALAT] greater than 80 U/L and/or Alkaline Phosphatase [AP] greater than 250U/L and/or Gamma Glutamyl Transpeptidase [GGT] greater than 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 (e.g. eczema, 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 1. Mean itch intensity score at endpoint, 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:<br>1 - (mean itch intensity score end point/mean itch intensity score baseline) x 100%
- Secondary Outcome Measures
Name Time Method