Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Pain of Procedure Rating
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 0 to 17 years inclusive;
- •with a laceration that is less than 3 cm in length (the upper limit recommended for tissue adhesive repair by the manufacturer).
- •with said laceration on the face, torso, trunk or extremities;
- •with said laceration deemed by the treating physician to be appropriate for repair via tissue adhesive
排除标准
- •the wound for study needs debridement or suturing prior to first glue attempt
- •said wound is an animal or human bite or scratch wound, puncture wound, stellate crush wound, wound crossing mucocutaneous junctions, a scalp laceration, an ear laceration, a wound crossing a joint line, a wound on the fingers or toes, or a wound in an area of concentrated hair such as the eyebrow
- •the patient has a history of keloid formation or
- •a known allergy to cyanoacrylates or
- •is presently taking oral steroids, immunostimulants, anticoagulants or other medications known to impair wound healing or haemostasis; or
- •has a known diagnosis of Diabetes Mellitus or Vascular Insufficiency
研究组 & 干预措施
Pre-treatment with LET
Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive
干预措施: LET - Lidocaine Epinephrine Tetracaine (Drug)
Pre-treatment with Placebo
Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive
干预措施: LET - Lidocaine Epinephrine Tetracaine (Drug)
结局指标
主要结局
Pain of Procedure Rating
时间窗: 2 minutes post-procedure
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).
次要结局
- Wound Cosmesis(measured at 3 month f/u visit)
- Ease of procedure as measured by treating physician(5 minutes post-procedure)
研究者
Stuart Harman
Dr. Stuart Harman MD FRCPC
Children's Hospital of Eastern Ontario