Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

Completed · Not applicable · Has a placebo group

Conditions studied: Contraception, Inhalation of Nitrous Oxide

In brief

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 nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen. The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.

Key facts

Study ID

NCT02312739

Run by

University of New Mexico

People needed

72

Starts

2014-02-01

Expected to finish

2015-03-01

Last updated by the study team

2016-07-06

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UNM Center for Reproductive Health — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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