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

NCT ID: NCT02391714

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-08-31

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).

Detailed 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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oxygen (Placebo)

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.

Group Type: PLACEBO_COMPARATOR

IUD insertion

Intervention Type: PROCEDURE

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-Iodine

Intervention Type: DRUG

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

Chlorhexidine

Intervention Type: DRUG

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.

Oxygen

Intervention Type: OTHER

100% oxygen via nasal mask.

Nitrous Oxide (NO)

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.

Group Type: EXPERIMENTAL

IUD insertion

Intervention Type: PROCEDURE

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-Iodine

Intervention Type: DRUG

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

Chlorhexidine

Intervention Type: DRUG

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.

Nitrous oxide

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

Povidone-Iodine

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

Intervention Type: 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.

Intervention Type: DRUG

Oxygen

100% oxygen via nasal mask.

Intervention Type: OTHER

Nitrous oxide

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

Intervention Type: OTHER

Other Intervention Names

Mirena® insertion; ParaGard® insertion; PDI®; ChloraPrep®

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rameet Singh, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UNM Division of Family Planning

Locations

Center for Reproductive Health

Albuquerque, New Mexico, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19527902 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19588429 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27481016 (View on PubMed)

Other Identifiers

UNMHSC 13-289

Identifier Type: -

Identifier Source: org_study_id