Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion (NIUD)
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| ClinicalTrials.gov Identifier: NCT02391714 |
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Recruitment Status :
Completed
First Posted : March 18, 2015
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Contraception | Procedure: IUD insertion Drug: Povidone-Iodine Drug: Chlorhexidine Other: Oxygen Other: Nitrous oxide | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Nitrous Oxide for Pain Management of Intrauterine Device Insertion |
| Study Start Date : | October 2013 |
| Actual Primary Completion Date : | August 2014 |
| Actual Study Completion Date : | August 2014 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 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. |
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.
Other Names:
Drug: Povidone-Iodine Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
Other Name: PDI® 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.
Other Name: ChloraPrep® Other: Oxygen 100% oxygen via nasal mask. |
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Experimental: 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. |
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.
Other Names:
Drug: Povidone-Iodine Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
Other Name: PDI® 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.
Other Name: ChloraPrep® Other: Nitrous oxide Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask. |
- Mean Maximum Procedural Pain Scores [ Time Frame: 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.
- Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391714
| United States, New Mexico | |
| Center for Reproductive Health | |
| Albuquerque, New Mexico, United States, 87106 | |
| Principal Investigator: | Rameet Singh, MD MPH | UNM Division of Family Planning |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT02391714 |
| Other Study ID Numbers: |
UNMHSC 13-289 |
| First Posted: | March 18, 2015 Key Record Dates |
| Results First Posted: | February 3, 2016 |
| Last Update Posted: | February 3, 2016 |
| Last Verified: | January 2016 |
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pain assessment patient satisfaction Visual Analog Scale contraceptive devices nulliparity |
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Chlorhexidine Povidone-Iodine Nitrous Oxide Povidone Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Plasma Substitutes Blood Substitutes |
Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |