Study of Pain Control With Hormonal IUS Insertion
Completed · Phase 4 · Has a placebo group
Conditions studied: Pain
In brief
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).
Key facts
- Study ID
- NCT02352714
- Run by
- Children's Hospital of Philadelphia
- People needed
- 98
- Starts
- 2015-01-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-09-14
Who can join
Age: 14 and older, up to 22. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University Hospitals — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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