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

Purpose

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.

Condition	Intervention	Phase
Pain Venipuncture Anesthetics, Local	Drug: Synera Patch Drug: LMX 4 Cream Drug: Placebo Patch	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Tetracaine Tetracaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by CAMC Health System:

Primary Outcome Measures:

Face Pain Scale-Revised (FPS-R) [ Time Frame: Before the medication application, after the medication removal and after the venipuncture ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Observed Behavioral Distress Scale (OBDS) [ Time Frame: Before, during and after venipuncture ] [ Designated as safety issue: No ]
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).
Draize Scale for Adverse Skin Reactions [ Time Frame: After removal of the patch or Tegaderm ] [ Designated as safety issue: Yes ]
The investigator will record the skin reactions after removal of the patch (active or placebo) or the Tegaderm.
Venipuncture Difficulty [ Time Frame: After venipuncture ] [ Designated as safety issue: No ]
After completing the venipuncture the phlebotomist will rate the difficulty of this procedure.

Estimated Enrollment:	150
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Synera Patch Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)	Drug: Synera Patch Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site Other Name: Synera
Experimental: LMX-4 Cream LMX-4 (liposomal lidocaine 4%) cream	Drug: LMX 4 Cream LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site. Other Name: LMX-4
Placebo Comparator: Placebo Patch Placebo Patch	Drug: 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. Other Name: Placebo

Detailed 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.

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115062

Locations

United States, West Virginia
Women and Children Hospital
Charleston, West Virginia, United States, 25304

Sponsors and Collaborators

Carol Morreale

Investigators

Principal Investigator:

James M. Turner, DO

Charleston Area Medical Center, Emergency Department

More Information

No publications provided

Responsible Party:	Carol Morreale, Clinical Pharmacist Specialist, CAMC Health System
ClinicalTrials.gov Identifier:	NCT01115062 History of Changes
Other Study ID Numbers:	09-10-2182
Study First Received:	April 15, 2010
Last Updated:	December 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by CAMC Health System:

Pain
Children
Local anesthetics

Additional relevant MeSH terms:

Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013