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 range14 Years – 24 Years

SexFEMALE

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

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