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

Pain Clinical Trial

— Xylocaine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562144
• Other study ID #: Isala
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2015
• Last updated: May 24, 2017
• Start date: April 5, 2016
• Est. completion date: April 7, 2016

Study information

• Verified date: May 2017
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 7, 2016
• Est. primary completion date: April 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Xylocaine spray
Cutaneous xylocaine spray before intravenous cannulation.
• Placebo
Cutaneous placebo before intravenous cannulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications or adverse reactions of xylocaine spray or placebo spray		5 minutes after xylocaine spray or placebo and 15 minutes after cannulation
Secondary	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
Secondary	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