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

NCT02562144 | Completed Phase 4

• 1 other identifier: Isala
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• The degree of difficulty in successfully placing an IV cannulation

  A few seconds after intravenous cannulation

Study Arms (2)

Xylocaine spray

EXPERIMENTAL

Drug: Xylocaine spray

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Xylocaine spray DRUG

Cutaneous xylocaine spray before intravenous cannulation.

Also known as: Bananenspray, Lidocaine spray

Xylocaine spray

Placebo DRUG

Cutaneous placebo before intravenous cannulation.

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Isala: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joris Datema, Drs

  Isala Zwolle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 29, 2015
• Study Start: April 5, 2016
• Primary Completion: April 6, 2016
• Study Completion: April 7, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share