CompletedPhase 4

10% Lidocaine Spray for Intrauterine Device Insertion

Thailand124 participantsStarted 2018-08-01

Plain-language summary

Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Woman who required for Copper T IUD insertion * Body mass index 18.5 - 30 kg/m2 * Communicable with Thai language * New IUD user Exclusion Criteria: * Suspicion of pregnancy * Puerperal sepsis/Immediate post-septic abortion * Untreated abnormal uterine bleeding * Uterine anomaly/abnormal pathology distorting the uterine cavity * Current pelvic inflammatory disease * Untreated cervicitis/vaginitis * Wilson's disease * Copper allergy * known hypersensitivity to local anaesthetic * Analgesic or anxiolytic use within the last 24 h before the procedure

What they're measuring

Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale

Timeframe: Immediately after the procedure

Trial details

NCT IDNCT03870711

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-17

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