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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-05

Study Completion Date

2016-04-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Xylocaine spray

Group Type EXPERIMENTAL

Xylocaine spray

Intervention Type DRUG

Cutaneous xylocaine spray before intravenous cannulation.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Cutaneous placebo before intravenous cannulation.

Interventions

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Xylocaine spray

Cutaneous xylocaine spray before intravenous cannulation.

Intervention Type DRUG

Placebo

Cutaneous placebo before intravenous cannulation.

Intervention Type DRUG

Other Intervention Names

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Bananenspray Lidocaine spray NaCl

Eligibility Criteria

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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 )

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes