A Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults

Study Overview
=================
Brief Summary
-----------------
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 the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.

Detailed Description
-----------------
The enrolled subjects will get an intravenous cannulation in both elbows. The influence of the left or right-handedness is reduced by randomizing the arms of the subjects in the placebo group or xylocaine group. 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 the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.

Official Title
-----------------
A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Xylocaine spray
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (aged 18 or older) Signing of the informed consent paper 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 )

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylocaine spray<br> | Drug: Xylocaine spray<br>* Cutaneous xylocaine spray before intravenous cannulation.<br>* Other names: Lidocaine spray;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Cutaneous placebo before intravenous cannulation.<br>* Other names: NaCl;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain score of the tested subjects during intravenous cannulation | Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain) | A few seconds after intravenous cannulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications or adverse reactions of xylocaine spray or placebo spray |  | 5 minutes after xylocaine spray or placebo and 15 minutes after cannulation | 
| Influence of xylocaine spray in successfully placing an IV cannulation | Is the cannulation easy or difficult to access on a scale, 0 to 10 (0 = easy, 10 = very difficult, almost impossible). | Before intravenous cannulation | 
| The degree of difficulty in successfully placing an IV cannulation | Indicate in a scale from 10 (0 = easy, 10 = very difficult, almost impossible) or the cannulation was easy or difficult to access | A few seconds after intravenous cannulation |