Lidocaine Patches Prior to Intravenous Insertion

Phase 2

Completed

• Conditions: Need for Intravenous Catheter
• Interventions: Device: Lidocaine tetracaine; Device: Placebo

• Registration Number: NCT00552695
• Lead Sponsor: Stony Brook University

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.

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-02
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-10-16
• Results First Submitted QC: 2010-11-05
• Results First Posted: 2010-12-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-19
• Last Update Posted: 2012-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

• Unstable patients,
• Allergy to lidocaine or tetracaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lidocaine tetracaine	Lidocaine 70 mg/tetracaine 70 mg skin patch
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain on Visual Analog Scale (VAS)	0 MINUTES	Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).

Secondary Outcome Measures

Name	Time	Method
Success of Intravenous (IV) Insertion	After first attempt of catheter insertion	Percentage of patients in whom intravenous catheter was inserted successfully

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States