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

NCT02651207 | Withdrawn DMC

• 1 other identifier: 2015OB09
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  one year

Study Arms (2)

local anaesthetic spray group

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

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

local anaesthetic injection group

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.

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

Interventions

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 OTHER

local anaesthetic injection group; local anaesthetic spray group

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient who choose to use the contraceptive implant as a method of contraception and who are deemed medically eligible for the method with no medical contrainidications

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tayside Medical Science Centre: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share