Compare topical anesthetic patches, Rapydan versus Emla
- Conditions
- Venipuncture, especially in children, is associated with pain and discomfort. For this reason, often use a local anesthetic.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-000750-37-NL
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Indication for vena puncture.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Allergy to the product and a plaster
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To identify which medicinal plaster prevents vena punction-induced pain the best.;Secondary Objective: Potential side effects of the medicinal plaster:<br>- redness<br>- oedema <br>Access to the vein;Primary end point(s): The effectiveness of EMLA and Rapydan anesthetic patches during venipuncture in children. Where pain is the primary endpoint.;Timepoint(s) of evaluation of this end point: the Faces Pain Scale en the VAS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary objectives are the occurrence of side effects such as itching and swelling and the need of the shots;Timepoint(s) of evaluation of this end point: questionnaire