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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562144
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
J. Datema, 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Xylocaine spray Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults
Actual Study Start Date : April 5, 2016
Actual Primary Completion Date : April 6, 2016
Actual Study Completion Date : April 7, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xylocaine spray Drug: Xylocaine spray
Cutaneous xylocaine spray before intravenous cannulation.
Other Names:
  • Bananenspray
  • Lidocaine spray

Placebo Comparator: Placebo Drug: Placebo
Cutaneous placebo before intravenous cannulation.
Other Name: NaCl




Primary Outcome Measures :
  1. The pain score of the tested subjects during intravenous cannulation [ Time Frame: A few seconds after intravenous cannulation ]
    Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)


Secondary Outcome Measures :
  1. Complications or adverse reactions of xylocaine spray or placebo spray [ Time Frame: 5 minutes after xylocaine spray or placebo and 15 minutes after cannulation ]
  2. Influence of xylocaine spray in successfully placing an IV cannulation [ Time Frame: Before intravenous cannulation ]
    Is the cannulation easy or difficult to access on a scale, 0 to 10 (0 = easy, 10 = very difficult, almost impossible).

  3. The degree of difficulty in successfully placing an IV cannulation [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562144


Sponsors and Collaborators
Isala
Investigators
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Principal Investigator: Joris Datema, Drs Isala Zwolle
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Responsible Party: J. Datema, Master of Science, Isala
ClinicalTrials.gov Identifier: NCT02562144    
Other Study ID Numbers: Isala
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action