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

A Randomized 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Xylocaine spray; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Cutaneous placebo before intravenous cannulation.; Other Names: NaCl
EXPERIMENTAL: Xylocaine spray	Drug: Xylocaine spray; Cutaneous xylocaine spray before intravenous cannulation.; Other Names: Bananenspray; Lidocaine spray

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Is the cannulation easy or difficult to access on a scale, 0 to 10 (0 = easy, 10 = very difficult, almost impossible).	Before intravenous cannulation
The degree of difficulty in successfully placing an IV cannulation	Indicate in a scale from 10 (0 = easy, 10 = very difficult, almost impossible) or the cannulation was easy or difficult to access	A few seconds after intravenous cannulation

Collaborators and Investigators

• Sponsor: Isala
• Investigators: Principal Investigator: Joris Datema, Drs, Isala Zwolle

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2016
• Primary Completion (ACTUAL): April 6, 2016
• Study Completion (ACTUAL): April 7, 2016

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 26, 2015
• First Posted (ESTIMATE): September 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Isala

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No