NCT02391714

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 3, 2016

Completed
Last Updated

February 3, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

March 5, 2015

Results QC Date

August 26, 2015

Last Update Submit

January 4, 2016

Conditions

Contraception

Keywords

pain assessmentpatient satisfactionVisual Analog Scalecontraceptive devicesnulliparity

Outcome Measures

Primary Outcomes (1)

  • Mean Maximum Procedural Pain Scores

    Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.

    2 minutes after the procedure.

Secondary Outcomes (2)

  • Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS

    Prior to clinic discharge, which is an average of 15 minutes after the procedure

  • Baseline Mean Pain Scores

    Before the IUD insertion procedure

Study Arms (2)

Oxygen (Placebo)

PLACEBO COMPARATOR

100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure. If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.

Procedure: IUD insertionDrug: Povidone-IodineDrug: ChlorhexidineOther: Oxygen

Nitrous Oxide (NO)

EXPERIMENTAL

Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes. If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.

Procedure: IUD insertionDrug: Povidone-IodineDrug: ChlorhexidineOther: Nitrous oxide

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.

Also known as: Mirena® insertion, ParaGard® insertion
Nitrous Oxide (NO)Oxygen (Placebo)
Povidone-IodineDRUG

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

Also known as: PDI®
Nitrous Oxide (NO)Oxygen (Placebo)
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.

Also known as: ChloraPrep®
Nitrous Oxide (NO)Oxygen (Placebo)
OxygenOTHER

100% oxygen via nasal mask.

Oxygen (Placebo)
Nitrous oxideOTHER

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

Nitrous Oxide (NO)

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 OR between the ages of 12-17 with a parent/legal guardian who can consent
  • English speaking
  • Desires a Mirena® or ParaGard® IUD
  • Nulliparous woman
  • Can use laughing gas
  • Has not taken narcotic pain medications prior to procedure

You may not qualify if:

  • Currently pregnant
  • If you have been pregnant before, pregnancy lasting longer than 19 weeks, 6 days
  • Less than 4 weeks have elapsed from the end of a spontaneous abortion or medical abortion.
  • Desires Skyla® IUD
  • Pelvic Inflammatory Disease in the last 3 months
  • Current mucopurulent discharge
  • Uterine anomaly that distorts the uterine cavity
  • Known uterine fibroid with disruption of the uterine cavity
  • Copper allergy/Wilson's disease (for ParaGard®)
  • Current cervical or uterine cancer
  • Inability to breathe through the nose
  • Significant active upper airway infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Health

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (3)

  • Allen RH, Goldberg AB, Grimes DA. Expanding access to intrauterine contraception. Am J Obstet Gynecol. 2009 Nov;201(5):456.e1-5. doi: 10.1016/j.ajog.2009.04.027. Epub 2009 Jun 13.

    PMID: 19527902BACKGROUND

  • Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.

    PMID: 19588429BACKGROUND

  • Singh RH, Thaxton L, Carr S, Leeman L, Schneider E, Espey E. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016 Nov;135(2):145-148. doi: 10.1016/j.ijgo.2016.04.014. Epub 2016 Jul 16.

    PMID: 27481016DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Povidone-IodineChlorhexidineOxygenNitrous Oxide

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidinesChalcogensElementsGasesNitrogen OxidesNitrogen CompoundsOxidesOxygen Compounds

Results Point of Contact

Title
Sunderjeet Kaur
Organization
Division of Family Planning, University of New Mexico
skaur@salud.unm.edu
Email

Study Officials

  • Rameet Singh, MD MPH

    UNM Division of Family Planning

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 18, 2015

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 3, 2016

Results First Posted

February 3, 2016

Record last verified: 2016-01

Locations

US(1)