2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMount Sinai Hospital, Canada
About this trial
The aim of this study is to determine if 5g of self-administered topical 2.5% lidocaine/2.5% prilocaine cream, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). Participants will be asked to self-administer the pre-filled vaginal applicator at least 10-15 minutes prior to the procedure. The patient will be asked to rate their pain throughout various steps of the procedure and complete a post-procedure survey afterwards. The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
English speaking participants only
Disqualifiers
Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
Misoprostol administration within 24 hours
Confirmed pregnancy
Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
Trial design
Design model
Parallel
Treatments tested in this trial
2.5% lidocaine/2.5% prilocaine topical cream
Drug5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator
VersaPro Cream Base for Compounding
Other intervention5g of VersaPro cream administered by participant by vaginal self-applicator
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: Medicated creamExperimental treatment 1 intervention
Group B: Placebo creamPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Global pain score
Patient-reported pain measured using the 100-mm Visual Analogue Scale (VAS) 5 minutes following the procedure (endometrial biopsy or IUD insertion). The VAS ranges from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain (a worse outcome).
Time frame
Completed by patient 5-minutes post procedure.Secondary outcomes
1
Pain scores at specific pain points during procedure
Pain scores at specific pain points: baseline after insertion of cream, after insertion of the speculum, removal of excess cream with gauze, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure, which will be patient-reported verbally during the procedure on a scale from 0 (i.e. no pain) to 10 (worst pain imaginable). When more than one biopsy pass is required, only pain after the first pass will be recorded.
Time frame
During the procedure2
Anxiety levels
Patient-reported anxiety before and after the procedure, measured using a 5-point Likert scale ranging from 1 (very anxious) to 5 (very calm). Higher scores indicate less anxiety (a better outcome).
Time frame
After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.3
Immediate complications of endometrial biopsy and/or IUD insertion
Provider-reported immediate complications associated with the endometrial biopsy and/or IUD insertion, including difficulty of procedure, vasovagal reaction, vital sign changes, or other procedure-related complications. This will be assessed by the presence or absence of specific procedure-related complications.
Time frame
Completed by the provider immediately after the procedure (within 30 mins post procedure).4
Difficulty of procedure
The difficulty of the procedure will be assessed with a Likert scale from 1 (least difficult) to 5 (most difficulty), provider reported.
Time frame
Completed by the provider immediately after the procedure (within 30 mins post procedure).Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: