Nitrous Oxide for Pain Management During Intrauterine Device Insertion in Nulliparous Adolescent Women
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Anesthetic acceptability: Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD procedures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparous (no pregnancy of 24 weeks' duration or longer and not currently pregnant)
- •adolescent females (14-24 years)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nitrous oxide gas for inhalation (Drug)
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.
干预措施: Oxygen Gas for Inhalation (Drug)
结局指标
主要结局
Anesthetic acceptability: Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD procedures
时间窗: Immediately after intervention/procedure
Proportion reporting that inhaled nitrous oxide anesthesia should be available for IUD (yes, no, not sure) procedures
Procedural satisfaction: VAS
时间窗: Immediately after intervention/procedure
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
Pain management satisfaction:
时间窗: Immediately after intervention/procedure
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
次要结局
- Experience-expectation discrepancy (pain)(Immediately after intervention/procedure)
- Procedural acceptability (peers)(Immediately after intervention/procedure)
- Experience-expectation discrepancy (anxiety)(Immediately after intervention/procedure)
- Procedural acceptability (self)(Immediately after intervention/procedure)
- Procedure-related anxiety rating(Immediately after intervention/procedure)
- Procedural pain rating(Immediately after intervention/procedure)
研究者
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
Boston Children's Hospital