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临床试验/NCT04378283
NCT04378283已完成不适用

Prospective Evaluation of Topical Anesthesia in Children

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
1
主要终点
Pain during skin repair

研究概览

简要总结

This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine.

详细描述

Pain caused by repair of torn skin is usually an unpleasant experience for pediatric patients. Analgesia or pain control is conventionally achieved by local anaesthetic infiltration. Local anaesthetics are a class of drugs that interrupt the transmission of electrical impulses along sensory nerves by inactivating sodium channels (Eidelman et al., 2011). However, the infiltration of local anaesthetics, which involves injecting the medication into the skin, may itself cause significant pain and fear in children (Kundu and Achar, 2002, Boettcher et al., 2012).

Pain management has been increasingly recognized as an element of high quality patient care, yet studies have shown deficiencies in pediatric emergency department (PED) pain management in children (Lawton and Hadj, 2014, Fein et al., 2012). Resolution of pain and perception of pain have been documented as one of the top indicators of patient and parent satisfaction and measure of quality of care in the PED (Magaret et al., 2002). Children are particularly susceptible to pain, even when caused by simple procedures (Boettcher et al., 2012). Well-managed pain has been associated with faster recoveries, fewer complications, and decreased use of health care resources (Zhu et al., 2012).

LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. LET gel offers many advantages for repair of tissue laceration including epinephrine-induced vasoconstriction, promotion of dry surfaces required for tissue adhesive laceration repair, and reduction of discomfort (MacLean et al., 2007). Topical anesthetics have been shown to improve procedural success rates and reduce procedural times, likely due to decreased patient movement and pain reduction (Taddio et al., 2005). LET has been shown to significantly reduce the need for injecting local anesthetics to the wound site, which is a cause of much anxiety and pain in children (Taddio et al., 2005, Singer and Stark, 2001).

In many PED - as in our department - LET solution and EMLA pretreatment and subsequent lidocaine infiltration are used depending on the personal experience and preference of the physician. The objective of this study is to determine if LET solution is as effective as EMLA and lidocaine infiltration in terms of comfort and effectiveness.

Primary Hypothesis:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Chronological age above 3 and below 18 years
  • Dermal laceration that needs surgical repair
  • Signed informed consent by the parent or guardian of the patient

排除标准

  • Skin laceration of nose tip, fingers, genitalia

研究组 & 干预措施

LET as topical anesthetic for wound repair.

Experimental

LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair.

干预措施: LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) (Drug)

EMLA plus infiltration as anesthetic for wound repair.

Active Comparator

EMLA ("eutectic mixture of local anesthetics") with subsequent lidocaine infiltration. EMLA is a mixture of lidocaine (2.5%) and prilocaine (2.5%) in a cream base.

干预措施: EMLA plus infiltration as anesthetic for wound repair. (Drug)

结局指标

主要结局

Pain during skin repair

时间窗: 2 weeks

Pediatric pain scale

次要结局

  • Infections during skin repair(2 weeks)
  • Speed during skin repair(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Michael Boettcher

PD Dr. Michael Boettcher

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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