CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Povidone-Iodine +4 moredrug
Likely dose
Not stated in 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/NCT02391714
NCT02391714N/ACompleted

Nitrous Oxide for Pain Management of Intrauterine Device Insertion

University of New Mexico·interventional·Posted Mar 18, 2015·Updated Feb 3, 2016

In Brief

A clinical study evaluating IUD insertion, Povidone-Iodine, and 3 other interventions for Contraception. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether Nitrous Oxide is effective in achieving pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 18, 2015
Enrollment StartOct 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.3 years ago

Interventions

IUD insertionprocedure

The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.

Povidone-Iodinedrug

Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.

Chlorhexidinedrug

For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic swab for the cervix prior to IUD insertion.

Oxygenother

100% oxygen via nasal mask.

Nitrous oxideother

Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.