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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00353002
First received: July 14, 2006
Last updated: April 12, 2007
Last verified: August 2006
  Purpose

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.


Condition Intervention
Pain
Drug: Ametop (4% Amethocaine cream )
Drug: Maxilene (4% Liposomal Lidocaine)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Comparison of Amethocaine Creams Versus Liposomal Lidocaine Cream as Pain Reliever Prior to Venipuncture in Children at the Paediatric Emergency Department.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • number of successful venous cannulations
  • Facial pain scale score of child during procedure

Secondary Outcome Measures:
  • Efficacy of amethocaine cream and liposomal lidocaine cream for venous cannulation
  • Compare local and systemic side effects of both creams

Estimated Enrollment: 60
Study Start Date: July 2006
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353002

Contacts
Contact: Michael J. Rieder, MD PhD FRCPC 519-685-8293 mrieder@uwo.ca

Locations
Canada, Ontario
Children's Hospital of Western Ontario Recruiting
London, Ontario, Canada, N6C 2V5
Contact: Michael J Rieder, MD PhD FRCPC    519 685 8293    mrieder@uwo.ca   
Sub-Investigator: Khalid Alawi, MD FRCPC         
Principal Investigator: Michael J Rieder, MD PhD FRCPC         
Sub-Investigator: Rod Lim, MD FRCPC         
Sub-Investigator: Tim Lynch, MD FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael J Rieder, MD PhD FRCPC Children's Hospital of Western Ontario, University of Western Ontario
Study Director: Khalid Alawi, MD FRCPC Children's Hospital of Western Ontario
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00353002     History of Changes
Other Study ID Numbers: REB11730
Study First Received: July 14, 2006
Last Updated: April 12, 2007
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Pain
Ametop
Liposomal Lidocaine
Venous cannulation

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014