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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02651207
• Other study ID #: 2015OB09
• Status: Withdrawn
• Phase: N/A
• First received: January 7, 2016
• Last updated: February 16, 2017
• Start date: November 2016
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Tayside Medical Science Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tayside Medical Science Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion	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	one year
Secondary	acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion	Questionnaire looking at the reasons why women chose to use the injection or the spray	one year