Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children

Pain Clinical Trial

Official title:

Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115062
• Other study ID #: 09-10-2182
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2010
• Last updated: January 31, 2014
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.

Description:

This study will compare the effectiveness of a patch applied for 30 minutes (Synera-lidocaine 70 mg/tetracaine 70 mg) with the effectiveness of a cream (LMX-4- 4% liposomal lidocaine) and a placebo patch applied for the same length of time in reducing pain due to needle sticks in children. One hundred fifty children and adolescents 5-17 years old admitted to emergency department or presenting to the phlebotomy lab. will be randomly placed in each group. Children will rate their level of pain using the Faces Pain Scale-Revised (FPS-R) before the medication is applied, after the medication is removed and after the needle stick. Parents and research observer will fill out the Observed Behavioral Distress (OBD) score. The phlebotomist will rate how difficult it was to perform the needle sticks. Any skin reaction seen by the investigator after the cream or patch is removed will be noted and compared among the three groups.

Subjects will be monitored from the time of enrollment to 5 minutes post phlebotomy.The Time Frame for which data will be presented is one (1) year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children requiring venipuncture for medical care

• The ability to demonstrate proper understanding of the Faces Pain Scale-Revised (FPS-R)

• Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain

Exclusion Criteria:

• Damaged or inflamed skin at the designated application site

• Known sensitivity to components of Synera or LMX-4 (lidocaine, tetracaine, or local anesthetics of the amide or ester type, PABA derivatives)

• Contraindications to Synera or LMX-4 use (severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)

• Use of analgesics during the past 24 hours

• Teenage female participants who are pregnant or lactating

• If in the attending's judgment the patient cannot wait wait 30 minutes for a blood drawn. These conditions include but are not limited to: sepsis, trauma, surgical emergencies, severe dehydration.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthetics, Local
• Pain
• Venipuncture

Intervention

Drug:
• Synera Patch
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site
• LMX 4 Cream
LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.
• Placebo Patch
A placebo patch with the same properties as the Synera patch but without lidocaine/tetracaine will be administered for 30 minutes to the venipuncture site.

Locations

Country	Name	City	State
United States	Women and Children Hospital	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carol Morreale

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Face Pain Scale-Revised (FPS-R)	The child's understanding of the FPS-R will be pretested. Using the scale, the child will rate the level of pain experienced before the medication (patch, cream) application, after the medication removal and after the venipuncture.	Before the medication application, after the medication removal and after the venipuncture	No
Secondary	Observed Behavioral Distress Scale (OBDS)	The parent, and a blinded research observer will complete the Observed Behavioral Distress Scale (OBDS) tool, which evaluates the observed patient distress at placement of the tourniquet (before venipuncture), at the needle insertion (during venipuncture), and at the placement of the adhesive bandage (after venipuncture).	Before, during and after venipuncture	No
Secondary	Draize Scale for Adverse Skin Reactions	The investigator will record the skin reactions after removal of the patch (active or placebo) or the Tegaderm.	After removal of the patch or Tegaderm	Yes
Secondary	Venipuncture Difficulty	After completing the venipuncture the phlebotomist will rate the difficulty of this procedure.	After venipuncture	No