Determine if Rapydan does influence routine clinical chemistry and hematology measurements
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijnbestrijding voorafgaand aan een venapunctie of aanleggen infuus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Routine Clinical Chemistry measurements differences
Secondary outcome
not present
Background summary
There is an increasing awareness of the importance of treating
procedure-related pain. Patients undergoing vascular access procedures are
often afraid of needles and the discomfort associated with injections. This
type of pain and/or fear can be stressful to patients. For prevention of the
pain associated with these procedures, the hospital is using Rapydan plasters.
Rapydan consists out of two local anesthetics: lidocaine and tetracaïne.
Rapydan produces topical anesthesia after an application time of 30 minutes and
is used in Dutch Hospitals for pain relieve by venapunction and IV cannulation.
The venous blood draining the anaesthetized skin contains a higher blood
concentration of the local anesthetics than does venous blood in other parts of
the body. Although the concentrations of the local anesthetics are low in
patients with normal skin, the question is whether the presence of the local
anesthetics which Rapydan contains might influence routine measurements in
clinical chemistry and hematology
Study objective
Determine if Rapydan does influence routine clinical chemistry and hematology
measurements
Study design
Observational study with invasive measurements
Study burden and risks
1 hour presence at the GP's Lab, Damsterdiep Groningen, receiving 2
venipunctures, 30 minutes application of Rapydan Patch. Reading study
information and writing informed concent. Risk are as normal venipuncture and
the risk of side effects of Rapydan Patch.
Postbus 909
9700 AX Groningen
Nederland
Postbus 909
9700 AX Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Healthy, not seriously ill, patient descision competent, not allergic for local anesthetics lidocain and tetracaïne
Exclusion criteria
younger than 20 and older than 60
Hypersensitivity to the active substances(lidocaine and tetracaïne, to sodium borate or to any of the other excipients. Hypersensitivity to local anaesthetics of the amide or ester type or to para-aminobenzoic acid (by-product in tetracaine metabolism). Patients using Class I antiarrhythmic medicinal products (such as quinidine, disopyramide, tocainide and mexiletine) and class III antiarrhythmic medicinal products (e.g. amiodarone) or other products containing local anaesthetic agents.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00765934 |
| CCMO | NL24080.099.08 |