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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Xylocaine spray; Drug: Placebo

• Registration Number: NCT02562144
• Lead Sponsor: Isala

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.

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-26
• Study First Posted: 2015-09-29
• Study Start: 2016-04-05
• Primary Completion: 2016-04-06
• Study Completion: 2016-04-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Adults (aged 18 or older)
• Signing of the informed consent paper

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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 )

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xylocaine spray	Xylocaine spray	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The pain score of the tested subjects during intravenous cannulation	A few seconds after intravenous cannulation	Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)

Secondary Outcome Measures

Name	Time	Method
Complications or adverse reactions of xylocaine spray or placebo spray	5 minutes after xylocaine spray or placebo and 15 minutes after cannulation
Influence of xylocaine spray in successfully placing an IV cannulation	Before intravenous cannulation	Is 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 cannulation	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