Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

NACompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
ContraceptionInhalation of Nitrous Oxide
Interventions
PROCEDURE

In-office Transcervical Sterilization (Essure®)

The standard transcervical sterilization procedure is not being evaluated in this study, and will be performed in the same manner in the two study arms. The procedure includes a standardized paracervical block with 1% lidocaine. A 5mm operative hysteroscope is passed through the cervix and into the uterine cavity using normal saline for uterine distention. Each tubal ostium is identified, followed by deployment of the device into each fallopian tube. A confirmatory test, hysterosalpingogram, is required at 90 days post procedure to demonstrate successful sterilization.

DRUG

Standard Oral pain medications

one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure

DRUG

Intramuscular Ketorolac

30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure

DRUG

Placebo pills

Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure

OTHER

Oxygen

Oxygen at 5L/min given to patients randomized to the active comparator arm

OTHER

Nitrous Oxide

Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm

Trial Locations (1)

87106

UNM Center for Reproductive Health, Albuquerque

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Society of Family Planning

OTHER

collaborator

Bayer

INDUSTRY

lead

University of New Mexico

OTHER