The enrolled subjects will get an intravenous cannulation in both elbows. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in de other arm before placebo spray is placed, the control arm. The pain score during insertion of de cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation.
Conditions
Interventions
Product Name: Xylocaine spray
Product Code: D04AB01
Pharmaceutical Form: Cutaneous spray
INN or Proposed INN: Xylocaine
CAS Number: 137-58-6
Other descriptive name: LIDOCAINE
Concentration unit: mg mi
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (aged 18 or older) Signing of the informed consent paper 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 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy for xylocaine Pregnancy or breast-feeding Peripheral neuropathy Analgesics in the last 24 hours Skin conditions (eczema, psoriasis, infection, or abrasions) Difficulties in verbal communication No intravenous access in both elbows possible (eg status after axillary dissection)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Has xylocaine spray an analgesic effect during the insertion of an intravenous cannulation?;Secondary Objective: Are there any side effects when using xylocaine spray? Does xylocaine spray affect the successful placement of an intravenous cannulation?;Primary end point(s): The pain score of the tested subjects during intravenous cannulation.;Timepoint(s) of evaluation of this end point: When all subjects were enrolled and data processing has been completed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complications or adverse reactions of xylocaine spray Influence of xylocaine spray in successfully placing an IV cannulation The degree of difficulty in successfully placing an IV cannulation;Timepoint(s) of evaluation of this end point: When all subjects were enrolled and data processing has been completed. | — |
Countries
Netherlands
Outcome results
None listed