Clinical trial NCT04089852: Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women
Official title: Nitrous Oxide for Pain Management During Intrauterine Device Insertion in Nulliparous Adolescent Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Contraceptive Devices
Long-Acting Reversible Contraception
Analgesia
Adolescent Health
Gynecology
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Praxair Distribution, Inc.
First posted: 2019-09-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Pain management satisfaction:
timeFrame: Immediately after intervention/procedure
measure: Anesthetic acceptability: Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD procedures
timeFrame: Immediately after intervention/procedure
measure: Procedural satisfaction: VAS
timeFrame: Immediately after intervention/procedure
Secondary outcomes:
measure: Experience-expectation discrepancy (pain)
timeFrame: Immediately after intervention/procedure
measure: Experience-expectation discrepancy (anxiety)
timeFrame: Immediately after intervention/procedure
measure: Procedural acceptability (self)
timeFrame: Immediately after intervention/procedure
measure: Procedural acceptability (peers)
timeFrame: Immediately after intervention/procedure
measure: Procedure-related anxiety rating
timeFrame: Immediately after intervention/procedure
measure: Procedural pain rating
timeFrame: Immediately after intervention/procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: