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Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion

NCT02391714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-02-03

Study results available
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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).

Conditions

  • Contraception

Interventions

PROCEDURE

IUD insertion

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.

DRUG

Povidone-Iodine

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

DRUG

Chlorhexidine

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.

OTHER

Oxygen

100% oxygen via nasal mask.

OTHER

Nitrous oxide

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

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02391714 on ClinicalTrials.gov