ContraceptionNIUDNCT02391714
Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion
A study testing IUD insertion, Povidone-Iodine and Chlorhexidine in people with Contraception, run by University of New Mexico at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- IUD insertion, Povidone-Iodine and Chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Reproductive Health
Albuquerque, New Mexico, 87106
About this study
Official title: 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).
Read the 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
- Being tested
- IUD insertion, Povidone-Iodine, Chlorhexidine, Oxygen, Nitrous oxide
- Keywords
- pain assessment, patient satisfaction, Visual Analog Scale, contraceptive devices, nulliparity
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD insertionProcedure or surgery
Also called Mirena® insertion, ParaGard® 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.
Povidone-IodineDrug
Also called PDI®
Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
ChlorhexidineDrug
Also called ChloraPrep®
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.
OxygenOther
100% oxygen via nasal mask.
Nitrous oxideOther
Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen (Placebo) | Placebo comparator | 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. Receives: Procedure: IUD insertion; Drug: Povidone-Iodine; Drug: Chlorhexidine; Other: Oxygen |
| Nitrous Oxide (NO) | Experimental | 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. Receives: Procedure: IUD insertion; Drug: Povidone-Iodine; Drug: Chlorhexidine; Other: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes after the procedure.
Secondary outcomes (2)
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.
Measured: Prior to clinic discharge, which is an average of 15 minutes after the procedure
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.
Measured: Before the IUD insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Rameet Singh, MD MPH, Principal investigator, UNM Division of Family Planning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391714
- Sponsor's protocol ID
- UNMHSC 13-289
- Acronym
- NIUD
- Status last verified
- Jan 2016
- First submitted
- 5 Mar 2015
- Last updated
- 3 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19527902Allen 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.
PubMed 19588429Singh 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.
PubMed 27481016
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide for Pain Management of Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT02391714
- Acronym / sponsor ID
- NIUD / UNMHSC 13-289
- Conditions
- Contraception
- Keywords
- pain assessment, patient satisfaction, Visual Analog Scale, contraceptive devices, nulliparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen (Placebo) | Placebo comparator | Procedure: IUD insertion, Drug: Povidone-Iodine, Drug: Chlorhexidine, Other: Oxygen100% 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) | Experimental | Procedure: IUD insertion, Drug: Povidone-Iodine, Drug: Chlorhexidine, Other: Nitrous oxideNitrous 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUD insertionAlso: Mirena® insertion, ParaGard® insertionThe 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. | Procedure or surgery | Nitrous Oxide (NO), Oxygen (Placebo) |
| Povidone-IodineAlso: PDI®Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion. | Drug | Nitrous Oxide (NO), Oxygen (Placebo) |
| ChlorhexidineAlso: ChloraPrep®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. | Drug | Nitrous Oxide (NO), Oxygen (Placebo) |
| Oxygen100% oxygen via nasal mask. | Other | Oxygen (Placebo) |
| Nitrous oxideGiven in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask. | Other | Nitrous Oxide (NO) |
Primary outcome
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.
2 secondary outcomes
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
Baseline Mean Pain Scores
Time frame: Before the IUD insertion procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19527902Allen 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.
- Background: PubMed 19588429Allen 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.
- Derived from this study: PubMed 27481016Singh 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.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rameet Singh, MD MPH principal investigator
UNM Division of Family Planning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD insertion, Povidone-Iodine and Chlorhexidine in people with Contraception, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Maximum Procedural Pain Scores (time frame: 2 minutes after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391714, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.