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

Not Applicable

Completed

Conditions: Contraception

Interventions: Procedure: IUD insertion
Drug: Povidone-Iodine
Drug: Chlorhexidine
Other: Oxygen
Other: Nitrous oxide

Registration Number: NCT02391714

Lead Sponsor: University of New Mexico

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 80

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen (Placebo)	IUD insertion	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.
Oxygen (Placebo)	Chlorhexidine	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.
Oxygen (Placebo)	Oxygen	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.
Nitrous Oxide (NO)	IUD insertion	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.
Nitrous Oxide (NO)	Chlorhexidine	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.
Nitrous Oxide (NO)	Nitrous oxide	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.
Oxygen (Placebo)	Povidone-Iodine	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.
Nitrous Oxide (NO)	Povidone-Iodine	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.

Primary Outcome Measures

Name	Time	Method
Mean Maximum Procedural Pain Scores	2 minutes after the procedure.	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.

Secondary Outcome Measures

Name	Time	Method
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	Satisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.
Baseline Mean Pain Scores	Before the IUD insertion procedure	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.