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

Qualifiers

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

Treatments tested in this trial

  • 2.5% lidocaine/2.5% prilocaine topical cream
  • VersaPro Cream Base for Compounding

Treatment groups

174 Participants
are divided into 2 treatment groups

Sponsors and collaborators