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临床试验/NCT02651207
NCT02651207撤回不适用

Study Looking at Acceptability of Using Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion

Tayside Medical Science Centre0 个研究点开始时间: 2016年11月最近更新:
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试验速览

阶段
不适用
状态
撤回
发起方
主要终点
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion

研究概览

简要总结

Study to look at the acceptability of local anaesthetic spray versus injection, prior to contraceptive implant insertion

详细描述

Currently, patients undergoing contraceptive implant insertion are offered local anaesthetic with an injection before insertion. This study aims to look at whether patients find using the local anaesthetic spray more acceptable or equally acceptable to using local anaesthetic injection. Both are currently licensed products for use as skin anaesthesia but the spray is potentially quicker and involves less injections. Some areas of sexual health are already offering this option but there isn't much evidence as to which patients find more acceptable.

Patients in this study will be given a choice of anaesthetic asked to complete a short questionnaire, giving a pain score , on the pain rating scale of 0 to 10, ( being no pain to 10 being extremely painful. ) In addition, they will be asked to give the reasons for their choice. The questionnaire will be anonymous.

Average pain scores will be calculated between in group and compared.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
13 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient has chosen to use the implant as a method of contraception
  • Patients will be assessed for medical eligibility for the contraceptive implant have no contraindications to either the implant, lidocaine or the ethyl chloride spray. However, if they have a known sensitivity to either the spray or the lidocaine ejection, they will be offered the other.
  • Age between 13 and 55
  • Has capacity to consent
  • Has read the information sheet and consents to the study
  • This will be offered for insertions of implant only i.e. not implant removals

排除标准

  • Has a contraindication to have a contraceptive implant
  • Doesn't wish to have a implant
  • Allergy to either the implant, the lidocaine, the ethyl chloride or any of the incipient ingredients. Although patients will be given the option, if they have an allergy/contraindication to one of the products, they will be offered the other
  • Is under 13 or over 55

结局指标

主要结局

acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion

时间窗: one year

Questionnaire based study looking at pain scores on the numeric pain rating scale 0 to 10, 0 being no pain to 10 being extremely painful

次要结局

  • acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion(one year)

研究者

发起方
Tayside Medical Science Centre
申办方类型
Other
责任方
Sponsor

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