Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture

NCT00676364 | Completed Phase 4 Results DMC

• 1 other identifier: 1-20030313
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream.

Conditions

Pain; Anxiety

Keywords

pediatric patients; pain; anxiety; topical anesthetic; randomized control trial

Outcome Measures

Primary Outcomes (1)

• Pain From Venipuncture

  Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. "FACES" in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain.

  Pain was measured immediately after venipuncture.

Secondary Outcomes (1)

• Anxiety of Venipuncture

  During venipuncture

Study Arms (2)

4% lidocaine topical anesthetic cream

ACTIVE COMPARATOR

This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.

Drug: 4% lidocaine topical anesthetic cream

Placebo

PLACEBO COMPARATOR

This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.

Drug: Placebo cream

Interventions

4% lidocaine topical anesthetic cream DRUG

A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture

Also known as: 4% liposomal lidocaine (Brand name = LMX4)

4% lidocaine topical anesthetic cream

Placebo cream DRUG

A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture

Placebo

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children ages 5-18 years of age
• treated as an inpatient or outpatient at Lehigh Valley Hospital within the past 24 hours
• venipuncture order, and that order is their initial venipuncture order (required within 30 mins)

You may not qualify if:

• known allergy to EMLA, LMX4 or any of their ingredients
• known sensitivities to local anesthetics of the amide type, lidocaine or prilocaine
• G6PD deficiency
• methemoglobinemia or concomitant administration of methemoglobin-inducing agent
• brain injured or disoriented (Glasgow Coma Scale \<15)
• cognitively impaired (Mini Mental Status Exam \<28)
• active skin conditions at venipuncture site including frequent rashes, eczema or unexplained bruising

Sponsors & Collaborators

• Jenny Boucher, PharmD: lead

Study Sites (1)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (13)

• Koh JL, Fanurik D, Stoner PD, Schmitz ML, VonLanthen M. Efficacy of parental application of eutectic mixture of local anesthetics for intravenous insertion. Pediatrics. 1999 Jun;103(6):e79. doi: 10.1542/peds.103.6.e79.

  PMID: 10353976 BACKGROUND

• Lander J, Hodgins M, Nazarali S, McTavish J, Ouellette J, Friesen E. Determinants of success and failure of EMLA. Pain. 1996 Jan;64(1):89-97. doi: 10.1016/0304-3959(95)00100-X.

  PMID: 8867250 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

• Zempsky WT, Cravero JP; American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2004 Nov;114(5):1348-56. doi: 10.1542/peds.2004-1752.

  PMID: 15520120 BACKGROUND

• Lander J, Fowler-Kerry S, Oberle S. Children's venipuncture pain: influence of technical factors. J Pain Symptom Manage. 1992 Aug;7(6):343-9. doi: 10.1016/0885-3924(92)90087-x.

  PMID: 1517650 BACKGROUND

• Barnett P. Alternatives to sedation for painful procedures. Pediatr Emerg Care. 2009 Jun;25(6):415-9; quiz 420-2. doi: 10.1097/PEC.0b013e3181a93ff3.

  PMID: 19528768 BACKGROUND

• Koh JL, Harrison D, Myers R, Dembinski R, Turner H, McGraw T. A randomized, double-blind comparison study of EMLA and ELA-Max for topical anesthesia in children undergoing intravenous insertion. Paediatr Anaesth. 2004 Dec;14(12):977-82. doi: 10.1111/j.1460-9592.2004.01381.x.

  PMID: 15601345 BACKGROUND

• Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.

  PMID: 19690240 BACKGROUND

• Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9.

  PMID: 20003121 BACKGROUND

• Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. No abstract available.

  PMID: 2678015 BACKGROUND

• Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.

  PMID: 20921070 BACKGROUND

• Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.

  PMID: 2197679 BACKGROUND

• Kaweski S; Plastic Surgery Educational Foundation Technology Assessment Committee. Topical anesthetic creams. Plast Reconstr Surg. 2008 Jun;121(6):2161-2165. doi: 10.1097/PRS.0b013e318170a7a4.

  PMID: 18520909 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Convenience sample at one hospital site during dayshift hours Monday through Friday. Variable ages may increase the variance among pain measurements. Analyzed IV cannulation and lab draw together. We did not conduct interrater reliability testing.

Results Point of Contact

• Title: Jenny Boucher
• Organization: Lehigh Valley Health Network

jenny.boucher@LVH.com

610-402-8844

Study Officials

• Jenny Boucher, PharmD

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

• Scott Brenner, MD

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: March 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 25, 2012
• Results First Posted: September 25, 2012

Record last verified: 2012-08

Locations

US (1)