Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

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.

Conditions

• Contraception
• Inhalation 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

Sponsors & Collaborators

• Society of Family Planning

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• University of New Mexico

  lead OTHER

Principal Investigators

• Rameet Singh, MD, MPH · UNM OB GYN Division of Family Planning

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States

Study Locations