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

NCT ID: NCT04089852

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-11-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Inhaled nitrous oxide anesthesia

Patients will be assigned to a "pre-implementation" (control) group or a "post-implementation" (treatment) group. The first twelve participants will be the control group and the next twelve participants will be the treatment group. The treatment group will receive inhaled N2O/O2. All participants will receive pre-procedural standard of care for IUD insertions, including 400-600 mg ibuprofen orally at least 20 minutes prior to insertion to reduce post-procedure pain. The N2O will be gradually up-titrated to a goal ratio of 70/30 N2O/O2. N2O/O2 will be administered per Boston Children's Hospital (BCH) N2O sedation protocol. Prior to speculum placement, treatment group participants will receive the inhaled gas until minimal sedation is achieved per BCH sedation guidelines, such that the patient is cooperative, oriented, and tranquil. Inhaled N2O will be administered throughout the duration of the procedure.

Group Type: EXPERIMENTAL

Nitrous oxide gas for inhalation

Intervention Type: DRUG

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.

Inhaled oxygen placebo

Patients will be assigned to a "pre-implementation" (control) group or a "post-implementation" (treatment) group. The first twelve participants will be the control group and the next twelve participants will be the treatment group. The control group will receive inhaled O2 alone. All participants will receive pre-procedural standard of care for IUD insertions, including 400-600 mg ibuprofen orally at least 20 minutes prior to insertion to reduce post-procedure pain. Control group participants will receive 100% O2 for two minutes prior to speculum placement. Inhaled oxygen will be administered throughout the duration of the procedure.

Group Type: PLACEBO_COMPARATOR

Oxygen Gas for Inhalation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Praxair Distribution, Inc.

UNKNOWN

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amy DiVasta, MD

Associate Professor of Pediatrics, Harvard Medical School; Director, Young Women's Health Research; Co-Director, Adolescent Long-Acting Reversible Contraception (LARC) Program; Attending Physician, Division of Adolescent/Young Adult Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

000000

Identifier Type: -

Identifier Source: org_study_id