PainNCT00353002
A Comparison of Amethocaine Cream vs. Liposomal Lidocaine Cream for Venipuncture in Children.
A study testing Ametop (4% Amethocaine cream ) and Maxilene (4% Liposomal Lidocaine) in people with Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pain
- What is being tested?
- Ametop (4% Amethocaine cream ) and Maxilene (4% Liposomal Lidocaine)
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Amethocaine Creams Versus Liposomal Lidocaine Cream as Pain Reliever Prior to Venipuncture in Children at the Paediatric Emergency Department.
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.
- Conditions
- Pain
- Being tested
- Ametop (4% Amethocaine cream ), Maxilene (4% Liposomal Lidocaine)
- Keywords
- Pain, Ametop, Liposomal Lidocaine, Venous cannulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ametop (4% Amethocaine cream )Drug
Maxilene (4% Liposomal Lidocaine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial pain scale score of child during procedure
Measured: Immediate
Secondary outcomes (1)
Compare local and systemic side effects of both creams
Measured: Within hour of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJul 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Rieder, MD PhD FRCPC, Principal investigator, Children's Hospital of Western Ontario, University of Western OntarioKhalid Alawi, MD FRCPC, Study director, Children's Hospital of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353002
- Sponsor's protocol ID
- R-06-266
- Other IDs
- LHRI IRF
- Status last verified
- Aug 2017
- First submitted
- 14 Jul 2006
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 10566919Choy 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 10519337Taddio 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 15967972Lawson 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 7547043Bishai 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 10469814Eichenfield 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 12042548Cereda 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 15367381Bucalo 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 9598008Arrowsmith 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 10735838Zempsky 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Amethocaine Creams Versus Liposomal Lidocaine Cream as Pain Reliever Prior to Venipuncture in Children at the Paediatric Emergency Department.
- ClinicalTrials.gov ID
- NCT00353002
- Acronym / sponsor ID
- R-06-266
- Conditions
- Pain
- Keywords
- Pain, Ametop, Liposomal Lidocaine, Venous cannulation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jul 2006 (actual)
- Study completion
- Dec 2006
- First posted
- 17 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ametop (4% Amethocaine cream ) | Drug | – |
| Maxilene (4% Liposomal Lidocaine) | Drug | – |
Primary outcome
Facial pain scale score of child during procedure
Time frame: Immediate
1 secondary outcome
Compare local and systemic side effects of both creams
Time frame: Within hour of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Background: PubMed 10566919Browne 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.
- Background: PubMed 10519337Choy 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.
- Background: PubMed 15967972Taddio 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.
- Background: PubMed 7547043Lawson 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.
- Background: PubMed 10469814Bishai 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.
- Background: PubMed 12042548Eichenfield 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.
- Background: PubMed 15367381Cereda 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.
- Background: PubMed 9598008Bucalo 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.
- Background: PubMed 10735838Arrowsmith 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.
- Background: PubMed 15520120Zempsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ametop (4% Amethocaine cream ) and Maxilene (4% Liposomal Lidocaine) in people with Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial pain scale score of child during procedure (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353002, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.