MedDataX Logo

Lidocaine Patches Prior to Intravenous Insertion

NCT ID: NCT00552695

Last Updated: 2012-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Need for Intravenous Catheter

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intravenous catheter emergency department pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Lidocaine 70 mg/tetracaine 70 mg skin patch

Group Type ACTIVE_COMPARATOR

Lidocaine tetracaine

Intervention Type DEVICE

Lidocaine 70 mg/tetracaine 70 mg

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Placebo patch identical in appearance to Synera

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine tetracaine

Lidocaine 70 mg/tetracaine 70 mg

Intervention Type DEVICE

Placebo

Placebo patch identical in appearance to Synera

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Synera

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Unstable patients,
* Allergy to lidocaine or tetracaine
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam Singer

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adam J Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20076689

Identifier Type: -

Identifier Source: org_study_id