Status:
COMPLETED
Nitrous Oxide for Pain Management During In-office Transcervical Sterilization
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
Society of Family Planning
Bayer
Conditions:
Contraception
Inhalation of Nitrous Oxide
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitro...
Detailed Description
Hysteroscopic permanent sterilization with Essure® is increasingly performed in the outpatient setting. No optimal outpatient analgesia regimen has been identified for the Essure® procedure. The inves...
Eligibility Criteria
Inclusion
- Premenopausal women desiring permanent sterilization and have chosen to proceed with a transcervical sterilization approach
- Speaks English or Spanish
- If relying on state or federal funding for sterilization, must have appropriate federal consents signed 30 days prior to the sterilization procedure
- Agrees to either a hormonal endometrial preparation prior to the procedure or schedule the procedure during the follicular phase (days 5 through 12) of their menstrual cycle
- Sexually active who agrees to contraception for 3 months post procedure, including condoms, followed by a hysterosalpingogram (HSG) for confirmation of fallopian tubal occlusion.
Exclusion
- With contraindications for nitrous oxide including: respiratory infection, chronic obstructive pulmonary disease (COPD), intoxication or use of street drugs, inability to breathe through their nose.
- Have taken narcotic pain medications prior to coming to their appointment
- Unsure about desire to end fertility
- History of pelvic inflammatory disease in the past 3 months
- Pregnancy or suspicion of pregnancy
- Delivery or termination of a pregnancy within the last 6 weeks
- Known allergy to contrast
- Uterine anomalies
- Previous tubal surgery
- Cervical or endometrial cancer
- Allergy to Vicodin, lorazepam, or lidocaine.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02312739
Start Date
February 1 2014
End Date
March 1 2015
Last Update
July 6 2016
Active Locations (1)
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1
UNM Center for Reproductive Health
Albuquerque, New Mexico, United States, 87106