Analgesia Clinical Trial
Official title:
Nitrous Oxide for Pain Management During Intrauterine Device Insertion in Nulliparous Adolescent Women
Verified date | September 2022 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Praxair Distribution, Inc. |
United States,
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 |
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