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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carol Morreale, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01115062
First received: April 15, 2010
Last updated: January 31, 2014
Last verified: January 2014
  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:


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.


Enrollment: 150
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Pain
Children
Local anesthetics

Additional relevant MeSH terms:
Lidocaine
Tetracaine
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014