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Completed

NCT Number: NCT02562144

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

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Xylocaine spray

Drug

Cutaneous xylocaine spray before intravenous cannulation.

Other names: Bananenspray, Lidocaine spray

Placebo

Drug

Cutaneous placebo before intravenous cannulation.

Other names: NaCl

Primary outcomes

  1. The pain score of the tested subjects during intravenous cannulation

    Time frame: A few seconds after intravenous cannulation

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

Secondary outcomes

  1. Complications or adverse reactions of xylocaine spray or placebo spray

    Time frame: 5 minutes after xylocaine spray or placebo and 15 minutes after cannulation

  2. Influence of xylocaine spray in successfully placing an IV cannulation

    Time frame: Before intravenous cannulation

    Is the cannulation easy or difficult to access on a scale, 0 to 10 (0 = easy, 10 = very difficult, almost impossible).

  3. The degree of difficulty in successfully placing an IV cannulation

    Time frame: A few seconds after intravenous cannulation

    Indicate in a scale from 10 (0 = easy, 10 = very difficult, almost impossible) or the cannulation was easy or difficult to access

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Official study title

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

Acronym: Xylocaine

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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