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

Isala

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Xylocaine spray; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02562144

Isala

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 )

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Xylocaine spray

Experimental group

Treatment:

Drug: Xylocaine spray

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo