Study of Pain Control With Hormonal IUS Insertion (NCT02352714) | Clinical Trial Compass
CompletedPhase 4
Study of Pain Control With Hormonal IUS Insertion
United States98 participantsStarted 2015-01
Plain-language summary
This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a paracervical (n=46) block versus a sham paracervical block (n=46).
Who can participate
Age range14 Years – 22 Years
SexFEMALE
See this in plain English?
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Inclusion Criteria:
* Nulliparous (i.e., no pregnancy \> 24 weeks)
* Not currently pregnant
* Not pregnant in the past 6 weeks
* Willing to be randomized to a paracervical nerve block or sham paracervical block group
* Interested in using an intrauterine system (IUS)
* Able to read and provide written informed consent in English
Exclusion Criteria:
* An allergy, hypersensitivity, or absolute medical contra-indication to using lidocaine, other amino-amide local anesthetics, or to non-steroidal anti-inflammatory agents, such as ibuprofen
* A history of epilepsy or peptic ulcer disease
* Moderate to severe asthma that precludes non-steroidal anti-inflammatory drug (NSAID) use
* Hepatic or renal failure
* Moderate to severe cardiac disease
* Previous use of an IUS or a history of a prior failed IUS insertion
* Use of a narcotic or benzodiazepine in the past 24 hours
* Positive pregnancy test or reasonable risk of pregnancy
* Current cervicitis
* Intrauterine infection in the past 90 days
* Meet Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for IUS use
* Currently breastfeeding
What they're measuring
1
Self-reported pain
Timeframe: Intraoperative (At the time of insertion of the IUS)