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OpenTrials
Completed

NCT Number: NCT00552695

Lidocaine Patches Prior to Intravenous Insertion

This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.

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Key information

Conditions

Need for Intravenous Catheter Disease Attributes Emergencies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

About this study

Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 3,
  • Need for non-emergent intravenous catheter

Exclusion criteria

  • Unstable patients,
  • Allergy to lidocaine or tetracaine

Treatment and study plan

Lidocaine tetracaine

Device

Lidocaine 70 mg/tetracaine 70 mg

Other names: Synera

PLACEBO

Device

Placebo patch identical in appearance to Synera

Primary outcomes

  1. Pain on Visual Analog Scale (VAS)

    Time frame: 0 MINUTES

    Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).

Secondary outcomes

  1. Success of Intravenous (IV) Insertion

    Time frame: After first attempt of catheter insertion

    Percentage of patients in whom intravenous catheter was inserted successfully

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 2, 2007
Registry last updated
Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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