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

Pain Clinical Trial

Official title:

A Randomized, Placebo-Controlled Trial to Evaluate Pain and Anxiety During Venipuncture in Pediatric Patients With or Without Pre-treatment by a Topical Anesthetic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676364
• Other study ID #: 1-20030313
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2008
• Last updated: August 24, 2012
• Start date: March 2003
• Est. completion date: February 2008

Study information

• Verified date: August 2012
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other anesthetic medications prior to venipuncture. However, the time for the anesthetic to take affect is approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine 4% topical anesthetic cream (LMX4), which has a shorter acting time (30 minutes) compared to the EMLA, making it a more desirable medication when urgent labs are required. This medication is being evaluated to assess the anxiety and pain associated with venipuncture in 15 minutes versus the approved 30 minutes of pediatric patients treated as an inpatient or outpatient in the local Emergency Department, compared to standard care (no prior treatment).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Drug:
• 4% lidocaine topical anesthetic cream
A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture
• Placebo cream
A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jenny Boucher, PharmD

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. — View Citation

Kaweski S; Plastic Surgery Educational Foundation Technology Assessment Committee. Topical anesthetic creams. Plast Reconstr Surg. 2008 Jun;121(6):2161-5. doi: 10.1097/PRS.0b013e318170a7a4. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Anxiety of Venipuncture	Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.	During venipuncture	No