Clinical trial NCT02651207: Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion
Official title: Study Looking at Acceptability of Using Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Contraception
Lead sponsor: Tayside Medical Science Centre
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion
timeFrame: one year
Secondary outcomes:
measure: acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References: