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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Analgesia; Adolescent Health; Contraceptive Devices; Long-Acting Reversible Contraception; Gynecology
• Intervention / Treatment: Drug: Nitrous oxide gas for inhalation; Drug: Oxygen Gas for Inhalation

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Praxair Distribution, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 000000 (MRDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No