A Randomized Control Trial of Nitrous Oxide Use in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Visual Analog Pain Assessment Scale (0-10)
研究概览
简要总结
This will be a randomized control trial. All patients for whom an emergency provider determines that abscess drainage or laceration repair are necessary will be considered for enrollment. The provider must be willing to participate in the study and be certified to use Nitrous oxide. The investigators providers completed a training course to be certified to use Nitrous oxide. The patient must be age 18 or greater, consent to participate in the study, and be able to complete a satisfaction survey. If the patient states there is a possibility of pregnancy, the investigators will regress to our standard of care and perform a urine pregnancy test. Patients with a first trimester pregnancy will be excluded. Patients who agree to enroll in the study will be randomized to Nitrous oxide versus oxygen (to be administered through the same system), and will complete a survey after the procedure, as will the provider. There will be a separate block randomization for each procedure. Providers may select other agents of choice for analgesia/sedation, such as local anesthesia, and pain medications, based on their clinical judgment. If the patient appears to have inadequate analgesia during the procedure, the provider can elect to treat as is typically done (pain medications or local anesthetics) at their discretion. The survey will ask patients to give a self-reported pain score before and during their procedure (both to be completed after the procedure). It will also ask the patient/guardian and provider for a satisfaction level with the analgesia during the procedure. In addition, side effects and procedure start and stop time will also be documented. In addition to the survey, the investigators will document clinical characteristics including diagnosis, size of laceration or abscess, additional medications required and dosages, comorbidities, age, and gender. Other data that will be gathered will include which adjunctive analgesics/anesthetics were used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with:
- •A laceration or an abscess requiring primary repair or incision and drainage respectively, per the treating provider
排除标准
- •Age < 18 years
- •First trimester pregnancy
- •Inability to obtain written informed consent from subject or surrogate
研究组 & 干预措施
Nitrous Oxide
Patients receive nitrous oxide via mask.
干预措施: Nitrous Oxide (Drug)
Placebo (Oxygen)
Patients receive oxygen via mask.
干预措施: Oxygen (Other)
结局指标
主要结局
Visual Analog Pain Assessment Scale (0-10)
时间窗: 0-20 minutes after drug administration
Pain score will be collected after drug administration
次要结局
- Provider satisfaction score(0-20 minutes after drug administration)
- Patient satisfaction(0-20 minutes after drug administration)
