drugset / Trial / NCT01445756

Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion

NCT01445756

Phase 0 Completed 40 enrolled University of Wisconsin, Madison
RandomizedSingle-groupDouble-blindHealth-services research

Summary

Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.

Timeline

Start
2010-07
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 2 % Topical

Indications

No indication recorded.