Standard Treatment Or topical doxepin against Pruritus in burn patients

Phase 4

Completed

Conditions: itch
pruritus
10014982

Registration Number: NL-OMON39365

Lead Sponsor: Vereniging Samenwerkende Brandwondencentra Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 108

Inclusion Criteria

• Patients with healed burns and itch. Patients are divided into four groups i.e.
1) patients with partial thickness wounds, not exceeding 4 months postburn
2) patients with full thickness wounds, not exceeding 4 months postburn
3) patients with partial thickness wounds between 4 months postburn and 3 years postburn
4) patients with full thickness wounds between 4 months postburn and 3 years postburn
• Itch intensity as assessed by VAS score greater than or equal to 3
• Patients treated in one of the three Dutch burn centres
• Patients aged 18 years or older

Exclusion Criteria

- Inability to give informed consent by patient or legal representatives
- Inability to understand and fill in VAS scores and quality of life/pruritus assessment questionnaires, as judged by the treating physician
- (Active) cutaneous or systemic disease causing itch
- Any disease or condition which is associated with adverse effects using doxepin, that is:
Contra-indications Tavegil
- hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients
- porphyria
Precautions Tavegil:
- fructose intolerance
- narrow-angle glaucoma
- stenosing peptic ulcer
- pyloroduodenal obstruction
- prostatic hypertrophy with urinary retention and bladder neck obstruction
- galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- pregnancy and lactation
Contra-indications Xepin:
- hypersensitivity to any of its components.
Precautions Xepin
- glaucoma
- a tendency to urinary retention
- severe liver disease
- mania
- severe heart disease (including cardiac arrythmias)
- pregnancy and lactation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are change in mean pruritus intensity; VAS scores<br /><br>from baseline during 12 weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include quality of life as measured by the SF-36<br /><br>questionnaire, characteristics of the itch as measured by the Burn Itch<br /><br>Questionnaire, reported somnolence and response of erythema.<br /><br>Other study parameters include use of escape moisturizer and use of pressure<br /><br>garments. Furthermore age, gender, location of burn wound, post-burn period,<br /><br>total body surface area, size of itching area, length of period of itch,<br /><br>treatment before inclusion (if applicable) will be recorded.</p><br>