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CompletedNCT00552695Updated Oct 22, 2012Results posted

Lidocaine Patches Prior to Intravenous Insertion

A Phase 2 interventional study of Lidocaine tetracaine and Placebo in Need for Intravenous Catheter, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2012-10-22.

Sponsored by Stony Brook University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Need for Intravenous Catheter

Keywords

  • intravenous catheter
  • emergency department
  • pain
03

In context

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unstable patients,
  • Allergy to lidocaine or tetracaine
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    1

    Lidocaine 70 mg/tetracaine 70 mg skin patch

    Device: Lidocaine tetracaine

  • Placebo comparator
    2

    Device: Placebo

Interventions

  • DeviceLidocaine tetracaine

    Lidocaine 70 mg/tetracaine 70 mg

    Also known as: Synera

  • DevicePlacebo

    Placebo patch identical in appearance to Synera

06

What researchers measure

Primary outcomes

  1. Pain on Visual Analog Scale (VAS)

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

    Time frame: 0 MINUTES

Secondary outcomes

  1. Success of Intravenous (IV) Insertion

    Percentage of patients in whom intravenous catheter was inserted successfully

    Time frame: After first attempt of catheter insertion

07

Results

Posted Dec 6, 2010

Participant flow

Participant flow — Overall Study
MilestoneLIDODERM PatchControl Patch
Started2223
Completed2223
Not completed00

Outcome measures

SecondarySuccess of Intravenous (IV) Insertion

Percentage of patients in whom intravenous catheter was inserted successfully

Time frame:
After first attempt of catheter insertion
Reported as:
Number · Percentage of participants
Success of Intravenous (IV) Insertion
Percentage of participantsLIDODERM PatchControl Patch
Success of Intravenous (IV) Insertion1817
PrimaryPain on Visual Analog Scale (VAS)

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

Time frame:
0 MINUTES
Reported as:
Median · mm
Pain on Visual Analog Scale (VAS)
mmLIDODERM PatchControl Patch
Pain on Visual Analog Scale (VAS)18 (1 to 40)35 (20 to 59)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LIDODERM Patch—0/22 (0%)0/22 (0%)
Control Patch—0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)LIDODERM PatchControl PatchTotal
<=18 years222345
Between 18 and 65 years000
>=65 years000
Age Continuous
Age Continuous(years)LIDODERM PatchControl PatchTotal
Mean9.3 ± 4.310.8 ± 4.510 ± 4.3
Sex: Female, Male
Sex: Female, Male(Participants)LIDODERM PatchControl PatchTotal
Female91019
Male131326
Region of Enrollment
Region of Enrollment(participants)LIDODERM PatchControl PatchTotal
United States222345
08

Study locations

1 site
  • Stony Brook University Hospital
    Stony Brook, New York 11794, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00552695
Lead sponsor
Stony Brook University
Responsible party
Adam Singer (Research Director, Stony Brook University) — Principal investigator
First posted
Nov 2, 2007
Start date
Aug 2007
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
Dec 6, 2010
Last update
Oct 22, 2012

Study contacts

Adam J Singer, MD
principal investigator · Stony Brook University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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