The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children - Full Text View

Sponsored by:	Montefiore Medical Center
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00530803

Purpose

The objective of this study is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.

Condition	Intervention
Pain	Drug: EMLA Cream Drug: Synera Patch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment
Official Title:	The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Child rating of Pain [ Time Frame: after venipuncture ]

Secondary Outcome Measures:

Parent rating of child's pain [ Time Frame: after venipuncture ]
Blinded observer ratings of child's pain [ Time Frame: before, during, and after venipuncture ]

Estimated Enrollment:	100
Study Start Date:	September 2007

Arms	Assigned Interventions
A, 1: Active Comparator EMLA Cream will be applied to venipuncture site	Drug: EMLA Cream 60 minutes x1
A, 2: Active Comparator The Synera Patch will be applied to the venipuncture site	Drug: Synera Patch 20 minutes x1

Eligibility

Ages Eligible for Study:	4 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children in outpatient clinics requiring venipuncture for medical care
Ages 4-12 years old
The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking Scale
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 EMLA (lidocaine, tetracaine, or local anesthetics of the amide or sdter type, PABA derivatives)
Contraindications to SYnera or EMLA use (Severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
Use of analgesics during the past 24 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530803

Contacts

Contact: Catherine C Skae, MD

718-741-2460

cskae@montefiore.org

Locations

United States, New York
Children's Hospital at Montefiore	Recruiting
Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator:

Catherine C Skae, MD

Children's Hospital at Montefiore

More Information

Publications:

Arts SE, Abu-Saad HH, Champion GD, Crawford MR, Fisher RJ, Juniper KH, Ziegler JB. Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Pediatrics. 1994 May;93(5):797-801. Review.

Bishai R, Taddio A, Bar-Oz B, Freedman MH, Koren G. Relative efficacy of amethocaine gel and lidocaine-prilocaine cream for Port-a-Cath puncture in children. Pediatrics. 1999 Sep;104(3):e31.

Chen E, Zeltzer LK, Craske MG, Katz ER. Children's memories for painful cancer treatment procedures: implications for distress. Child Dev. 2000 Jul-Aug;71(4):933-47.

Cummings EA, Reid GJ, Finley GA, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31.

Eichenfield LF, Funk A, Fallon-Friedlander S, Cunningham BB. A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics. 2002 Jun;109(6):1093-9.

Fitzgerald M, Millard C, McIntosh N. Cutaneous hypersensitivity following peripheral tissue damage in newborn infants and its reversal with topical anaesthesia. Pain. 1989 Oct;39(1):31-6.

Halperin DL, Koren G, Attias D, Pellegrini E, Greenberg ML, Wyss M. Topical skin anesthesia for venous, subcutaneous drug reservoir and lumbar punctures in children. Pediatrics. 1989 Aug;84(2):281-4.

Humphrey GB, Boon CM, van Linden van den Heuvell GF, van de Wiel HB. The occurrence of high levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics. 1992 Jul;90(1 Pt 1):87-91.

Kapelushnik J, Koren G, Solh H, Greenberg M, DeVeber L. Evaluating the efficacy of EMLA in alleviating pain associated with lumbar puncture; comparison of open and double-blinded protocols in children. Pain. 1990 Jul;42(1):31-4.

Lawson RA, Smart NG, Gudgeon AC, Morton NS. Evaluation of an amethocaine gel preparation for percutaneous analgesia before venous cannulation in children. Br J Anaesth. 1995 Sep;75(3):282-5.

Ramsook C, Kozinetz CA, Moro-Sutherland D. Efficacy of ethyl chloride as a local anesthetic for venipuncture and intravenous cannula insertion in a pediatric emergency department. Pediatr Emerg Care. 2001 Oct;17(5):341-3. No abstract available.

Sethna NF, Verghese ST, Hannallah RS, Solodiuk JC, Zurakowski D, Berde CB. A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children. Anesthesiology. 2005 Feb;102(2):403-8.

Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F, Morrison V. Anxiety in children having elective surgery. J Pediatr Nurs. 2004 Apr;19(2):128-32.

Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

Study ID Numbers:	MontefioreMC
Study First Received:	September 13, 2007
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00530803
Health Authority:	United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:

pain
venipuncture
children

Study placed in the following topic categories:

EMLA
Pain

Additional relevant MeSH terms:

Anesthetics, Combined
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Anesthetics, Local
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009