CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Standard Oral pain medications +5 moredrug
Likely dose
Standard Oral pain medications 325mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02312739
NCT02312739N/ACompleted
CompareCT.gov

Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

University of New Mexico·interventional·Posted Dec 9, 2014·Updated Jul 6, 2016

In Brief

A clinical study evaluating In-office Transcervical Sterilization (Essure®), Standard Oral pain medications, and 4 other interventions for Contraception and Inhalation of Nitrous Oxide. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception, Inhalation of Nitrous Oxide
CountriesUnited States
CollaboratorsSociety of Family Planning, Bayer

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 9, 2014
Enrollment StartFeb 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.6 years ago

Interventions

In-office Transcervical Sterilization (Essure®)procedure

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.

Standard Oral pain medicationsdrug

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

Intramuscular Ketorolacdrug

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

Placebo pillsdrug

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

Oxygenother

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

Nitrous Oxideother

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