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

NCT04089852 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 000000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Experience-expectation discrepancy (pain)

  Immediately after intervention/procedure

• Experience-expectation discrepancy (anxiety)

  Immediately after intervention/procedure

• Procedural acceptability (self)

  Immediately after intervention/procedure

• Procedural acceptability (peers)

  Immediately after intervention/procedure

• Procedure-related anxiety rating

  Immediately after intervention/procedure

Study Arms (2)

Inhaled nitrous oxide anesthesia

EXPERIMENTAL

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.

Drug: Nitrous oxide gas for inhalation

Inhaled oxygen placebo

PLACEBO COMPARATOR

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.

Drug: Oxygen Gas for Inhalation

Interventions

Nitrous oxide gas for inhalation 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 nitrous oxide anesthesia

Oxygen Gas for Inhalation 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.

Inhaled oxygen placebo

Eligibility Criteria

• Age: 14 Years - 24 Years
• Gender Eligibility Details: Eligibility of female adolescents/young women is based on requirement for female anatomy (i.e., cervix) for IUD insertion. Eligibility is not based on representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• nulliparous (no pregnancy of 24 weeks' duration or longer and not currently pregnant)
• adolescent females (14-24 years)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Praxair Distribution, Inc.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Endothelium-Dependent Relaxing Factors; Inhalation; Oxygen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)