Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion

Withdrawn

• Conditions: Contraception
• Interventions: Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant

• Registration Number: NCT02651207
• Lead Sponsor: Tayside Medical Science Centre

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Start: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
local anaesthetic injection group	Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant	women will either chose ethyl chloride spray prior to having their contraceptive implant fitted or the injection, subcutaneous 1% lidocaine, usually a dose of about 1-2 mls to the area skin where the contraceptive implant is to be inserted.
local anaesthetic spray group	Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant	women will either chose the above, ethyl chloride spray prior to having their contraceptive implant fitted or the below injection. This comes in a canister and a maximum of 5 spray for 5 seconds will be applied topically to the skin at the site of the contraceptive implant insertion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion	one year	Questionnaire looking at the reasons why women chose to use the injection or the spray