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

Isala17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Pain

Interventions

Xylocaine sprayDRUG

Cutaneous xylocaine spray before intravenous cannulation.

PlaceboDRUG

Cutaneous placebo before intravenous cannulation.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 )

Outcomes

Primary Outcomes

The pain score of the tested subjects during intravenous cannulation

Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)

Time frame: A few seconds after intravenous cannulation

Secondary Outcomes

Complications or adverse reactions of xylocaine spray or placebo spray

Time frame: 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).

Time frame: 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

Time frame: A few seconds after intravenous cannulation

Data from ClinicalTrials.gov

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