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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04089852
• Other study ID #: 000000
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Praxair Distribution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain management satisfaction:	Patient satisfaction with their pain management during the procedure as measured on a 5-item Likert scale with 5 categories: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied	Immediately after intervention/procedure
Primary	Anesthetic acceptability: Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD procedures	Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD (yes, no, not sure) procedures	Immediately after intervention/procedure
Primary	Procedural satisfaction: VAS	Median visual analog scale (VAS) score for procedural pain management satisfaction, with scores ranging from 0 to 100 with 0=completely satisfied to 100= completely dissatisfied	Immediately after intervention/procedure
Secondary	Experience-expectation discrepancy (pain)	Proportion reporting reduction in procedural pain compared to anticipated procedural pain as measured by a choice of 3 responses: The procedure hurt LESS than I expected; The procedure hurt THE SAME as I expected; The procedure hurt MORE than I expected	Immediately after intervention/procedure
Secondary	Experience-expectation discrepancy (anxiety)	Proportion reporting reduction in procedural anxiety compared to anticipated procedural anxiety, with 3 answer choices: I felt LESS anxious than I expected; I felt THE SAME level of anxiety as I expected; I felt MORE anxious than I expected	Immediately after intervention/procedure
Secondary	Procedural acceptability (self)	Proportion reporting that dislike of the procedure would prevent them from getting another IUD in the future (yes, no, maybe)	Immediately after intervention/procedure
Secondary	Procedural acceptability (peers)	Proportion reporting willingness to recommend the IUD procedure to a friend, rated on a 100mm sliding scale ranging from 0 (not at all likely) to 100 (absolutely likely)	Immediately after intervention/procedure
Secondary	Procedure-related anxiety rating	Median visual analog scale (VAS) score for overall procedure-related anxiety, with scores ranging from 0 to 100 with 0=not at all anxious to 100=the most anxious	Immediately after intervention/procedure
Secondary	Procedural pain rating	Procedural pain rating as measured on a 100-mm visual analog scale (VAS) with scores ranging from 0 to 100, where 0= no pain and 100= the worst pain	Immediately after intervention/procedure