Gluing Lacerations Utilizing Epinephrine (GLUE)
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| First Received Date ICMJE | September 14, 2010 | ||||||||
| Last Updated Date | April 9, 2013 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain of Procedure Rating [ Time Frame: 2 minutes post-procedure ] [ Designated as safety issue: No ] Patients will rate the pain experienced during their procedure on a 100 mm Visual Analog Scale (in paitents age 6 and under, parents will rate what pain they believe their child experienced). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01202487 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Gluing Lacerations Utilizing Epinephrine | ||||||||
| Official Title ICMJE | Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy | ||||||||
| Brief Summary | Minor lacerations are a commonly treated injury in the paediatric emergency department . Over the past decade, standard closure of these lacerations has evolved from suture repair to closure with tissue adhesive (also referred to as "skin glue"). Local anaesthetic is not routinely used during application of skin glue as it was with sutures. There are, however, several potential advantages to pre-treating wounds with topical LET (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive properties. Some believe LET can improve patient comfort, increase the ease of glue application, and lead to better healing when used on lacerations being repaired with tissue adhesive. This study aims to address the question of whether or not pre-treatment with LET improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual Analog Scale) during repair with tissue adhesive. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Lacerations | ||||||||
| Intervention ICMJE | Drug: LET - Lidocaine Epinephrine Tetracaine
One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair
Other Names:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 222 | ||||||||
| Completion Date | April 2012 | ||||||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01202487 | ||||||||
| Other Study ID Numbers ICMJE | 6138378804 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Stuart Harman, Children's Hospital of Eastern Ontario | ||||||||
| Study Sponsor ICMJE | Children's Hospital of Eastern Ontario | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Eastern Ontario | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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