A Comparison of Amethocaine Cream vs. Liposomal Lidocaine Cream for Venipuncture in Children.

NCT00353002 | Withdrawn DMC

• 2 other identifiers: R-06-266LHRI IRF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

All patients undergoing venepuncture or venous cannulation in pediatric emergency department will be treated with either Amethocaine, or Liposomal Lidocaine (4%) cream at the site of cannulation in order to determine the efficacy of these creams in controlling pain during procedures and to determine the success rate of these procedures.

Conditions

Pain

Keywords

Pain; Ametop; Liposomal Lidocaine; Venous cannulation

Outcome Measures

Primary Outcomes (1)

• Facial pain scale score of child during procedure

  Immediate

Secondary Outcomes (1)

• Compare local and systemic side effects of both creams

  Within hour of procedure

Interventions

Ametop (4% Amethocaine cream ) DRUG

Maxilene (4% Liposomal Lidocaine) DRUG

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children age who are visiting the paediatric emergency department and need for IV cannulation or blood workup as part of their management. The need for IV placement or blood drawing will be based on the clinical evaluation of the child by experienced triage nursing personnel.

You may not qualify if:

• Lack of parental agreement
• Broken skin
• Known sensitivity to Amethocaine or Liposomal Lidocaine cream.
• Children with critical illness requiring immediate cannulation (e.g., sepsis, severe dehydration, Trauma)
• Children who are already receiving opioid analgesia or topical anesthesia.
• Children who have already participated in the study.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital of Western Ontario

London, Ontario, N6C 2V5, Canada

Location

Related Publications (10)

• Browne J, Awad I, Plant R, McAdoo J, Shorten G. Topical amethocaine (Ametop) is superior to EMLA for intravenous cannulation. Eutectic mixture of local anesthetics. Can J Anaesth. 1999 Nov;46(11):1014-8. doi: 10.1007/BF03013194.

  PMID: 10566919 BACKGROUND

• Choy L, Collier J, Watson AR. Comparison of lignocaine-prilocaine cream and amethocaine gel for local analgesia before venepuncture in children. Acta Paediatr. 1999 Sep;88(9):961-4. doi: 10.1080/08035259950168450.

  PMID: 10519337 BACKGROUND

• Taddio A, Soin HK, Schuh S, Koren G, Scolnik D. Liposomal lidocaine to improve procedural success rates and reduce procedural pain among children: a randomized controlled trial. CMAJ. 2005 Jun 21;172(13):1691-5. doi: 10.1503/cmaj.045316.

  PMID: 15967972 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

• 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

• 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

• Cereda CM, de Araujo DR, Brunetto GB, De Paula E. Liposomal prilocaine: preparation, characterization, and in vivo evaluation. J Pharm Pharm Sci. 2004 Jul 15;7(2):235-40.

  PMID: 15367381 BACKGROUND

• Bucalo BD, Mirikitani EJ, Moy RL. Comparison of skin anesthetic effect of liposomal lidocaine, nonliposomal lidocaine, and EMLA using 30-minute application time. Dermatol Surg. 1998 May;24(5):537-41. doi: 10.1111/j.1524-4725.1998.tb04203.x.

  PMID: 9598008 BACKGROUND

• Arrowsmith J, Campbell C. A comparison of local anaesthetics for venepuncture. Arch Dis Child. 2000 Apr;82(4):309-10. doi: 10.1136/adc.82.4.309.

  PMID: 10735838 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

MeSH Terms

Conditions

Pain

Interventions

Tetracaine; Maxilene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Michael J Rieder, MD PhD FRCPC

  Children's Hospital of Western Ontario, University of Western Ontario

  PRINCIPAL INVESTIGATOR

• Khalid Alawi, MD FRCPC

  Children's Hospital of Western Ontario

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2006
• First Posted: July 17, 2006
• Study Start: July 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)