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Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial
The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain
Details
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 200 |
| Start date | 2010-10 |
| Completion | 2013-06 |
Conditions
- Pain
Interventions
- 2% lidocaine gel
- placebo
Primary outcomes
- Pain During IUD Insertion at Various Time Points (See Description for Time Points) — During IUD insertion (see above description for which time points)
Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.
Countries
United States