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Contraceptive DevicesPhase 2/3NCT04089852

Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women

A Phase 2/3 study testing Nitrous oxide gas for inhalation and Oxygen Gas for Inhalation in people with Contraceptive Devices and Long-Acting Reversible Contraception, run by Boston Children's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot study aims to assess the feasibility, acceptability, and effectiveness of using nitrous oxide (N2O) sedation for intrauterine device (IUD) insertions for nulliparous adolescent and young adult women in a primary care clinic setting. Read more about this study

Who is it for?
Ages 14 to 24 years, women onlyHealthy volunteers can take part
What is being tested?
Nitrous oxide gas for inhalation and Oxygen Gas for Inhalation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to 1 Nov 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

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 14 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • nulliparous (no pregnancy of 24 weeks' duration or longer and not currently pregnant)
  • adolescent females (14-24 years)

Who cannot join

  • use of opioids, benzodiazepines, or marijuana within the past 24 hours
  • failure to meet medical eligibility criteria for an IUD
  • medical contraindications to NSAID use
  • relative contraindications to N2O administration, including severe pulmonary disease, congenital heart disease, diseases associated with vitamin B12 deficiency, and sickle cell disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Nitrous Oxide for Pain Management During Intrauterine Device Insertion in Nulliparous Adolescent Women

This pilot study aims to assess the feasibility, acceptability, and effectiveness of using nitrous oxide (N2O) sedation for intrauterine device (IUD) insertions for nulliparous adolescent and young adult women in a primary care clinic setting.

Read the detailed description

The objective of this research study is to learn more about how to make the intrauterine device (IUD) insertion procedure more comfortable. IUDs are highly effective at preventing pregnancy and are also used to treat gynecological conditions such as endometriosis or heavy periods. Unfortunately, many adolescents and young adults do not get an IUD because the insertion procedure can be painful. Currently, there are no medications that successfully reduce pain during IUD insertion for adolescents in the outpatient clinic setting.

We plan to study if nitrous oxide sedation is a feasible strategy for improving the IUD insertion experience for adolescents and young adult women. Although nitrous oxide is already used to manage pain and anxiety in other medical settings (such as for pain during labor or dental procedures), nitrous oxide sedation has not been rigorously studied for IUD insertions in teenagers and young adults.

During phase one of our study ("pre-implementation phase"), study participants will receive current standard of care (ibuprofen) for managing pain during IUD insertions. In phase two ("post-implementation phase"), study participants will receive nitrous oxide sedation in addition to ibuprofen during IUD insertions. We will survey study participants to assess the feasibility, acceptability, and effectiveness of nitrous oxide sedation for IUD insertions in the primary care clinic setting.

This study will help clinicians understand whether nitrous oxide could be a practical and effective way to manage pain and anxiety for adolescents during IUD insertion procedures. Ultimately, we hope this study will lead to increased satisfaction with the IUD insertion procedure and increased use of this highly effective method of contraception among adolescents.

Being tested
Nitrous oxide gas for inhalation, Oxygen Gas for Inhalation
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitrous oxide gas for inhalationDrug

    All inhaled gases will be administered via nasal mask using a portable nitrous oxide/oxygen (N2O/O2) machine. Environmental safety will be maintained with an N2O scavenger system and Porter Miniature Vacuum System. The treatment group will receive inhaled N2O/O2. The N2O will be gradually up-titrated to a goal ratio of 70/30 N2O/O2 and will be administered as outlined in the treatment arm description.

  • Oxygen Gas for InhalationDrug

    All inhaled gases will be administered via nasal mask using a portable nitrous oxide/oxygen (N2O/O2) machine. The control group will receive inhaled O2 alone. Control group participants will receive 100% O2 for two minutes prior to speculum placement. Inhaled oxygen will be administered continuously throughout the procedure as outlined in the control arm description.

Study groups in NCT04089852
Study groupRoleWhat they receive
Inhaled nitrous oxide anesthesiaExperimentalPatients will be assigned to a "pre-implementation" (control) group or a "post-implementation" (treatment) group. The first twelve participants will be the control group and the next twelve participants will be the treatment group. The treatment group will receive inhaled N2O/O2. All participants will receive pre-procedural standard of care for IUD insertions, including 400-600 mg ibuprofen orally at least 20 minutes prior to insertion to reduce post-procedure pain. The N2O will be gradually up-titrated to a goal ratio of 70/30 N2O/O2. N2O/O2 will be administered per Boston Children's Hospital (BCH) N2O sedation protocol. Prior to speculum placement, treatment group participants will receive the inhaled gas until minimal sedation is achieved per BCH sedation guidelines, such that the patient is cooperative, oriented, and tranquil. Inhaled N2O will be administered throughout the duration of the procedure.
Receives: Drug: Nitrous oxide gas for inhalation
Inhaled oxygen placeboPlacebo comparatorPatients will be assigned to a "pre-implementation" (control) group or a "post-implementation" (treatment) group. The first twelve participants will be the control group and the next twelve participants will be the treatment group. The control group will receive inhaled O2 alone. All participants will receive pre-procedural standard of care for IUD insertions, including 400-600 mg ibuprofen orally at least 20 minutes prior to insertion to reduce post-procedure pain. Control group participants will receive 100% O2 for two minutes prior to speculum placement. Inhaled oxygen will be administered throughout the duration of the procedure.
Receives: Drug: Oxygen Gas for Inhalation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain management satisfaction:

    Patient satisfaction with their pain management during the procedure as measured on a 5-item Likert scale with 5 categories: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied

    Measured: Immediately after intervention/procedure

  2. Anesthetic acceptability: Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD procedures

    Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD (yes, no, not sure) procedures

    Measured: Immediately after intervention/procedure

  3. Procedural satisfaction: VAS

    Median visual analog scale (VAS) score for procedural pain management satisfaction, with scores ranging from 0 to 100 with 0=completely satisfied to 100= completely dissatisfied

    Measured: Immediately after intervention/procedure

Secondary outcomes (6)

  1. Experience-expectation discrepancy (pain)

    Proportion reporting reduction in procedural pain compared to anticipated procedural pain as measured by a choice of 3 responses: The procedure hurt LESS than I expected; The procedure hurt THE SAME as I expected; The procedure hurt MORE than I expected

    Measured: Immediately after intervention/procedure

  2. Experience-expectation discrepancy (anxiety)

    Proportion reporting reduction in procedural anxiety compared to anticipated procedural anxiety, with 3 answer choices: I felt LESS anxious than I expected; I felt THE SAME level of anxiety as I expected; I felt MORE anxious than I expected

    Measured: Immediately after intervention/procedure

  3. Procedural acceptability (self)

    Proportion reporting that dislike of the procedure would prevent them from getting another IUD in the future (yes, no, maybe)

    Measured: Immediately after intervention/procedure

  4. Procedural acceptability (peers)

    Proportion reporting willingness to recommend the IUD procedure to a friend, rated on a 100mm sliding scale ranging from 0 (not at all likely) to 100 (absolutely likely)

    Measured: Immediately after intervention/procedure

  5. Procedure-related anxiety rating

    Median visual analog scale (VAS) score for overall procedure-related anxiety, with scores ranging from 0 to 100 with 0=not at all anxious to 100=the most anxious

    Measured: Immediately after intervention/procedure

  6. Procedural pain rating

    Procedural pain rating as measured on a 100-mm visual analog scale (VAS) with scores ranging from 0 to 100, where 0= no pain and 100= the worst pain

    Measured: Immediately after intervention/procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start1 Jun 2021 (estimated)
  3. Primary completion1 Nov 2021 (estimated)
  4. Study completion1 Nov 2021 (estimated)

Why it stopped: Not able to perform intervention in current physical clinic location

Resources

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 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089852
Sponsor's protocol ID
000000
Status last verified
Sep 2022
First submitted
11 Sep 2019
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nitrous oxide gas for inhalation and Oxygen Gas for Inhalation in people with Contraceptive Devices and Long-Acting Reversible Contraception, run by Boston Children's Hospital 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 Sep 2022. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Pain management satisfaction: (time frame: Immediately after intervention/procedure). The study lists 3 primary outcomes in all. 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 NCT04089852.

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 16 Sep 2022.

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