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WithdrawnNCT00353002Updated Aug 28, 2017

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

An interventional study of Ametop (4% Amethocaine cream ) and Maxilene (4% Liposomal Lidocaine) in Pain, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Withdrawn at 1 site in Canada. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-08-28.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
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Study 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.

Read the detailed description

Children commonly require blood taking or placement of an intravenous line for both diagnosis and treatment during their visit to the emergency department. The distress from needle puncture is a particular issue in children. The development of needle phobia can subsequently adversely affect the well-being of the children and their relationship with the medical staff. Thus reduction of pain and distress would be beneficial to patients, parents, and medical personnel.

Amethocaine (tetracaine 4%) (Ametop) is another topical anaesthetic cream which was marketed in Canada over the last 10 years; it was developed by Dr. David Wollfson at Queen's University, Belfast, the cream is available in a 1.5g tube that delivers only 1 dose, at a cost of ($3.24). structurally it has an ester type bond (Para-amino benzoic acid) and is formulated as a free base to allow tetracaine to diffuse across the skin barrier and reach pain receptors (nociceptors) which are located below the stratum corneum (outer most layer of skin). It acts by inhibiting sodium ion flux across the axon membrane thus preventing the nociceptors from signalling pain to the central nervous system. The application time required for the cream is only 30 minutes, and it possesses an action time of 4 hours after removal from the skin. Also Amethocaine has a low risk for methemoglobinemia, therefore it can be used safely in neonatal period and the only disadvantage of Amethocaine cream is skin erythema due to vasodilatation effect.

Liposomal lidocaine 4% cream (Maxilene, RGR Pharma, Windsor, Ontario) is another anaesthetic cream that was launched recently in Canada in 2003. And 5 gm tube priced is 15 $. The liposome-encapsulated formulation protects the anesthetic from being metabolized too quickly (12) It has short onset of action and minimal vasoactive properties that minimize any potential interference with cannulation success, and it is not associated with methemoglobinemia.

As of yet, there has not been a study done in children in the Emergency Department setting comparing the efficacy and side effects of both Liposomal Lidocaine cream and Amethocaine cream. Thus, there is no evidence guiding the use of these agents in Paediatric Emergency care setting, Furthermore using these creams are not considered standard care for children in Canada, and the usual clinical practice in Canadian emergency departments is not to use local anesthesia creams before IV insertion or blood extraction.

Thus, if positive the results of this study could be directly applied to changing the care of children in acute and emergency care setting.

Both creams have shown considerable potential in alleviating procedure pain, but both creams can also cause skin effect, and thus may affect the success rate of these procedures. Therefore we would like to test the two creams to demonstrate the efficacy of these two creams in controlling pain. As Liposomal Lidocaine is believed to have fewer side and skin effects than Amethocaine, it's possible that the success rate may be better with Liposomal Lidocaine than with Amethocaine cream and thus would be preferred agent for use for children in the Emergency and acute care setting.

02

Conditions studied

  • Pain

Keywords

  • Pain
  • Ametop
  • Liposomal Lidocaine
  • Venous cannulation
03

In context

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Interventions

  • DrugAmetop (4% Amethocaine cream )
  • DrugMaxilene (4% Liposomal Lidocaine)
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What researchers measure

Primary outcomes

  1. Facial pain scale score of child during procedure

    Time frame: Immediate

Secondary outcomes

  1. Compare local and systemic side effects of both creams

    Time frame: Within hour of procedure

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Study locations

1 site
  • Children's Hospital of Western Ontario
    London, Ontario N6C 2V5, Canada
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References and documents

Publications

  • 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. PubMed 10566919 ↗
  • 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. PubMed 10519337 ↗
  • 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. PubMed 15967972 ↗
  • 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. PubMed 7547043 ↗
  • 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. PubMed 10469814 ↗
  • 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. PubMed 12042548 ↗
  • 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. PubMed 15367381 ↗
  • 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. PubMed 9598008 ↗
  • 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. PubMed 10735838 ↗
  • 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. PubMed 15520120 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00353002
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Sponsor
First posted
Jul 17, 2006
Start date
Jul 2006
Completion
Dec 2006
Last update
Aug 28, 2017

Study contacts

Michael J Rieder, MD PhD FRCPC
principal investigator · Children's Hospital of Western Ontario, University of Western Ontario
Khalid Alawi, MD FRCPC
study director · Children's Hospital of Western Ontario

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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