Current Environment:

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.

Conditions

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

Recruitment Status

Not yet recruiting

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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Drug

Nitrous oxide gas for inhalation

Drug

Oxygen Gas for Inhalation

Phase

Phase 2, Phase 3

Gender

Female

Minimum Age

14 Years

Maximum Age

24 Years

Download Date

July 8, 2020

Principal Investigator

Amy DiVasta, MD

Primary Contact Information

Amy DiVasta, MD, MMSc

(617) 355-4453

Amy.DiVasta@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: