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



Status:Completed
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:August 2014

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Nitrous Oxide for Pain Management of Intrauterine Device Insertion

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).

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.

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
We found this trial at
1
site
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
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