Contraception
Conditions
Keywords
pain assessment, patient satisfaction, Visual Analog Scale, contraceptive devices, nulliparity
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.
Interventions
PROCEDUREIUD 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.
DRUGPovidone-Iodine
Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
DRUGChlorhexidine
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.
OTHEROxygen
100% oxygen via nasal mask.
OTHERNitrous oxide
Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
Sponsors
Society of Family Planning
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Oxygen: 100% oxygen via nasal mask. | 40 |
| 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.
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.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Oxygen (Placebo) | Nitrous Oxide (NO) | Total |
|---|---|---|---|
| Age, Continuous | 26.3 years | 24.93 years | 25.62 years |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: 2 minutes after the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen (Placebo) | Mean Maximum Procedural Pain Scores | 55.3 units on a scale | Standard Deviation 20.9 |
| Nitrous Oxide (NO) | Mean Maximum Procedural Pain Scores | 54.3 units on a scale | Standard Deviation 24.8 |
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.
Time frame: Before the IUD insertion procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen (Placebo) | Baseline Mean Pain Scores | 1.9 units on a scale | Standard Deviation 4.6 |
| Nitrous Oxide (NO) | Baseline Mean Pain Scores | 2.4 units on a scale | Standard Deviation 4.1 |
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.
Time frame: Prior to clinic discharge, which is an average of 15 minutes after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen (Placebo) | Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS | 60.3 units on a scale | Standard Deviation 26.6 |
| Nitrous Oxide (NO) | Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS | 66.0 units on a scale | Standard Deviation 32.2 |