A Comparison of Amethocaine Cream vs. Liposomal Lidocaine Cream for Venipuncture in Children.
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|ClinicalTrials.gov Identifier: NCT00353002|
Recruitment Status : Withdrawn
First Posted : July 17, 2006
Last Update Posted : August 28, 2017
|First Submitted Date ICMJE||July 14, 2006|
|First Posted Date ICMJE||July 17, 2006|
|Last Update Posted Date||August 28, 2017|
|Actual Study Start Date ICMJE||July 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Facial pain scale score of child during procedure [ Time Frame: Immediate ]|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00353002 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Compare local and systemic side effects of both creams [ Time Frame: Within hour of procedure ]|
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Comparison of Amethocaine Cream vs. Liposomal Lidocaine Cream for Venipuncture in Children.|
|Official Title ICMJE||A Comparison of Amethocaine Creams Versus Liposomal Lidocaine Cream as Pain Reliever Prior to Venipuncture in Children at the Paediatric Emergency Department.|
|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.|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Study Completion Date||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||5 Years to 12 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00353002|
|Other Study ID Numbers ICMJE||R-06-266
LHRI IRF ( Other Grant/Funding Number: LHRI )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Lawson Health Research Institute|
|Study Sponsor ICMJE||Lawson Health Research Institute|
|Collaborators ICMJE||Not Provided|
|PRS Account||Lawson Health Research Institute|
|Verification Date||August 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP