NCT00552695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

December 6, 2010

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

October 31, 2007

Results QC Date

October 16, 2009

Last Update Submit

October 19, 2012

Conditions

Need for Intravenous Catheter

Keywords

intravenous catheteremergency departmentpain

Outcome Measures

Primary Outcomes (1)

  • Pain on Visual Analog Scale (VAS)

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

    0 MINUTES

Secondary Outcomes (1)

  • Success of Intravenous (IV) Insertion

    After first attempt of catheter insertion

Study Arms (2)

1

ACTIVE COMPARATOR

Lidocaine 70 mg/tetracaine 70 mg skin patch

Device: Lidocaine tetracaine

2

PLACEBO COMPARATOR
Device: Placebo

Interventions

Lidocaine tetracaineDEVICE

Lidocaine 70 mg/tetracaine 70 mg

Also known as: Synera
1
PlaceboDEVICE

Placebo patch identical in appearance to Synera

2

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unstable patients,
  • Allergy to lidocaine or tetracaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

EmergenciesPain

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Adam Singer
Organization
Stony Brook U
adam.singer@stonybrook.edu
631-444-7857

Study Officials

  • Adam J Singer, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 22, 2012

Results First Posted

December 6, 2010

Record last verified: 2012-10

Locations

US(1)