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

Contraception Clinical Trial

— NIUD  

Official title:

Nitrous Oxide for Pain Management of Intrauterine Device Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391714
• Other study ID #: UNMHSC 13-289
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: January 4, 2016
• Start date: October 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

Long acting reversible contraception (LARC) including the IUD provides several advantages that may be attractive to women. These include non-daily use, rapid reversibility and low failure rates. The American College of Obstetricians and Gynecologists (ACOG) endorses the use of IUDs among adolescents and nulliparous women, dispelling the myth that IUD use is contraindicated in this population.

Rates of IUD uptake among nulliparous women have not been reported. There are some barriers that may help explain the low uptake of IUDs by teens and nulliparous women, including fear of pain during IUD insertion. This concern is also voiced by providers who perceive pain with IUD insertion to be higher among nulliparous women (Allen, Goldberg et al. 2009).

There is limited evidence comparing subjective pain scores with IUD insertion between nulliparous versus parous women. However, there have been a number of studies evaluating the efficacy of misoprostol, non steroidal anti-inflammatory drugs and local anesthesia in reducing pain during IUD insertion. These included comparisons of pain scores between both nulliparous and multiparous women and reported pain scores by group. These studies have failed to demonstrate evidence that any of the aforementioned interventions significantly reduce pain scores compared to placebo (Allen et al. 2009). We conclude that pain with IUD insertion among nulliparous and adolescent women is within the high range of pain scale measurement standards. Therefore, further investigations of optimizing pain management during this procedure are warranted in order to lead to increased acceptability and adoption of IUDs among this population of women.

Nitrous oxide (NO) is an inhaled gas administered with oxygen in a fixed ratio for analgesia and sedation. It has been used for many years for procedural analgesia and anesthesia in outpatient settings and it reduces anxiety, the perception of pain and alters consciousness. It is attractive for the clinic setting as it demonstrates rapid induction and rapid resolution, allows for patient control of use, exhibits few side effects and boasts a benign safety profile in the setting of scavenging systems and open air clinics. Furthermore, NO systems are relatively inexpensive and noninvasive.

For all these reasons, NO seems to be an ideal approach for pain management with IUD insertion for nulliparous women. No studies have investigated the use of NO in this context. The aim of our study is to objectively identify pain reduction scores and satisfaction with NO use compared to typical insertion practices during IUD insertion for nulliparous women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
United States	Center for Reproductive Health	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD007373. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS	Satisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.	Prior to clinic discharge, which is an average of 15 minutes after the procedure	No
Secondary	Baseline Mean Pain Scores	Baseline pain scores prior to IUD insertion 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.	Before the IUD insertion procedure	No