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

NCT00530803 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 07-06-159
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.

Conditions

Pain; Needle Phobia

Keywords

EMLA; venipuncture; children; Synera patch; pediatric; Lidocaine/prilocaine

Outcome Measures

Primary Outcomes (1)

• Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.

  Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, "no pain," to 5, "the most pain you can have." The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5.

  immediately after completion of venipuncture

Secondary Outcomes (4)

• Parent Rating of Child's Pain Using a 6-point NRS

  immediately after venipuncture is completed

• Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS

  before venipuncture

• Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS

  during needle insertion

• Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS

  5 minutes post venipuncture

Study Arms (2)

EMLA Cream

ACTIVE COMPARATOR

Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.

Drug: EMLA Cream

Synera Patch

ACTIVE COMPARATOR

Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.

Combination Product: Synera Patch

Interventions

EMLA Cream DRUG

60 minutes x1

Also known as: Lidocaine/prilocaine cream

EMLA Cream

Synera Patch COMBINATION_PRODUCT

20 minutes x1

Also known as: Lidocaine/tetracaine patch

Synera Patch

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 ester type, Para Aminobenzoic (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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Related Publications (14)

• 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.

  PMID: 8165081 BACKGROUND

• 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. doi: 10.1542/peds.104.3.e31.

  PMID: 10469814 BACKGROUND

• 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. doi: 10.1111/1467-8624.00200.

  PMID: 11016557 BACKGROUND

• Cummings EA, Reid GJ, Finley AG, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31. doi: 10.1016/S0304-3959(96)03163-6.

  PMID: 9251995 BACKGROUND

• 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. doi: 10.1542/peds.109.6.1093.

  PMID: 12042548 BACKGROUND

• 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):31-36. doi: 10.1016/0304-3959(89)90172-3.

  PMID: 2812853 BACKGROUND

• 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.

  PMID: 2748256 BACKGROUND

• 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.

  PMID: 1614786 BACKGROUND

• 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):31-34. doi: 10.1016/0304-3959(90)91088-Z.

  PMID: 2234995 BACKGROUND

• 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. doi: 10.1093/bja/75.3.282.

  PMID: 7547043 BACKGROUND

• 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. doi: 10.1097/00006565-200110000-00005. No abstract available.

  PMID: 11673710 BACKGROUND

• 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. doi: 10.1097/00000542-200502000-00025.

  PMID: 15681958 BACKGROUND

• 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. doi: 10.1016/s0882-5963(03)00146-5.

  PMID: 15077211 BACKGROUND

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

  PMID: 3344163 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Associate Professor, Dept of Pediatrics
• Organization: Montefiore Medical Center

cskae@montefiore.org

718-741-2460

Study Officials

• Catherine C Skae, MD

  Children's Hospital at Montefiore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-07

Locations

US (1)