NCT04089852

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

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: Female
• Age: 14 Years – 24 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Contraceptive Devices
• Long-Acting Reversible Contraception
• Analgesia
• Adolescent Health
• Gynecology

Interventions

Type	Name	Description
DRUG	Nitrous oxide gas for inhalation	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.
DRUG	Oxygen Gas for Inhalation	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2019-09-13
• Last updated: 2022-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study