WithdrawnPhase 2/3

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

Stopped: Not able to perform intervention in current physical clinic location

United States0Started 2021-06-01

Plain-language 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.

Who can participate

Age range

14 Years – 24 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * nulliparous (no pregnancy of 24 weeks' duration or longer and not currently pregnant) * adolescent females (14-24 years) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain management satisfaction:

Timeframe: Immediately after intervention/procedure

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

Timeframe: Immediately after intervention/procedure

Procedural satisfaction: VAS

Timeframe: Immediately after intervention/procedure

Trial details

NCT IDNCT04089852

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-01

View on ClinicalTrials.gov More Contraceptive Devices trials

Who can participate

Age range

14 Years – 24 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain management satisfaction:

Timeframe: Immediately after intervention/procedure

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

Timeframe: Immediately after intervention/procedure

Procedural satisfaction: VAS

Timeframe: Immediately after intervention/procedure