Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of New Mexico
• Collaborators: Bayer; Society of Family Planning
• Treatments: Acetaminophen, hydrocodone drug combination; Analgesics; Disinfectants; Ketorolac; Ketorolac Tromethamine; Lorazepam; Nitrous Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.