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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02562144
Acronym
Xylocaine
Enrollment
17
Registered
2015-09-29
Start date
2016-04-05
Completion date
2016-04-07
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGXylocaine spray

Cutaneous xylocaine spray before intravenous cannulation.

DRUGPlacebo

Cutaneous placebo before intravenous cannulation.

Sponsors

Isala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 )

Design outcomes

Primary

MeasureTime frameDescription
The pain score of the tested subjects during intravenous cannulationA few seconds after intravenous cannulationVisual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)

Secondary

MeasureTime frameDescription
Complications or adverse reactions of xylocaine spray or placebo spray5 minutes after xylocaine spray or placebo and 15 minutes after cannulation
Influence of xylocaine spray in successfully placing an IV cannulationBefore intravenous cannulationIs the cannulation easy or difficult to access on a scale, 0 to 10 (0 = easy, 10 = very difficult, almost impossible).
The degree of difficulty in successfully placing an IV cannulationA few seconds after intravenous cannulationIndicate in a scale from 10 (0 = easy, 10 = very difficult, almost impossible) or the cannulation was easy or difficult to access

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026