Assesing topical analgesia during painful cures.
- Conditions
- Evaluate pain reduction during wound cleaning after previous application of topic solution of lidocaine vs. placeboTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2017-002352-91-ES
- Lead Sponsor
- Dra Antònia Dalmau i LLitjós del Servicio de Anestesia, Reanimación y Terapéutica del dolor del HUB -Idibell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 46
a) signed and dated informed consent before randomization process
b) male or female
c) older or equal to 18 years
d) Patients with painful wound care
e) Wounds or ulcers of any origin (vascular deficit, diabetic, traumatic, postsurgical ...) with skin damaged
f) Women with a negative result on a pregnancy test.
g) Men and women of childbearing potential must agree to use effective contraception throughout treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
a) history of allergic reaction to local anesthetics of the amide type.
b) Wounds or ulcers of grade I (injury seamless skin)
c) very large wounds (requiring more than 20 ml of solution)
d) periocular Wounds
e) Patients with impaired cardiac conduction atrioventricular block of 2nd or 3rd degree heart block or bifascicular
f) Patients with altered level of consciousness
g) Patients on hemodialysis, peritoneal dialysis or continuous hemofiltration
h) Patients with moderate or severe hepatic impairment
i) Pregnant or breast-feeding.
j) Patients who refuse to participate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method