A Randomized, Placebo Controlled Trial of Nitrous Oxide/Oxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Overall Pain (10-point NRS)
研究概览
简要总结
The goal of this clinical trial is to assess if a mix of nitrous oxide and oxygen can improve pain control during bladder Botox injections. The primary question it aims to answer is: Does using nitrous oxide lower the overall level of pain during the procedure?
Researchers will compare a 50:50 nitrous oxide/oxygen mixture (administered with the Pro-Nox system) plus standard care (with lidocaine in the bladder) to sham mask plus standard care to see if nitrous oxide works better for lowering pain.
Participants will:
- Receive their bladder Botox injection in the office setting
- Either use nitrous oxide/oxygen plus standard care during the procedure, or sham mask plus standard care
- Answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure
详细描述
This study will assess if a 50:50 nitrous oxide and oxygen mixture can lower pain in women undergoing in-office bladder onabotulinumtoxinA (Botox) injections. Many people report pain during this procedure, and pain is a common reason not to repeat the procedure. Nitrous oxide is a fast-acting inhaled analgesic that is used commonly in the office setting.
This randomized controlled trial will compare nitrous oxide/oxygen plus standard care with sham mask plus standard care. Participants assigned to the nitrous oxide group will receive nitrous oxide via the Pro-Nox device during the procedure. Both, participants assigned to the nitrous oxide group and the standard care alone group, will receive the usual lidocaine instilled in the bladder for at least 15 minutes.
The study will measure participants overall pain during the procedure. It will also assess peak pain, overall anxiety, satisfaction, willingness to repeat, interest in using nitrous oxide in future bladder Botox procedures, and side effects. Nitrous oxide is expected to wear off within minutes, allowing participants to leave the clinic without restrictions.
This research study would be first randomized-controlled trial to evaluate nitrous oxide for pain management during this common in-office procedure.
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
- Single (Participant)
盲法说明
The participants will be masked to sham mask versus mask with nitrous oxide/oxygen. Masking of the investigators would not be feasible given the use of participant self-administered inhaled nitrous oxide gas.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
排除标准
- •Known/suspected vitamin B12 or folate deficiency or high-risk state (e.g., pernicious anemia, malabsorption, post-bariatric or strict vegan without supplementation)
- •currently pregnant
- •severe/unstable pulmonary disease or baseline hypoxemia requiring supplemental home oxygen
- •eye or ear surgery in the last six weeks
- •trapped-air conditions (e.g., untreated pneumothorax, bowel obstruction)
- •severe active otitis/sinus disease
- •inability to follow directions
- •history of adverse reaction to nitrous oxide
研究组 & 干预措施
Nitrous Oxide Plus Standard Care
Participants in this group will receive standard care plus 50:50 mix of inhaled nitrous oxide/oxygen self-administered using the Pro-Nox system during the bladder Botox procedure.
干预措施: Standard Care for Bladder Botox Injection (Drug)
Sham Mask Plus Standard Care
The sham mask plus standard care group will receive a mask that is connected to the Pro-Nox system but with the valves turned completely off; therefore they will inhale room air plus standard care: intravesical instillation of 1-2% lidocaine solution (30-50 mL) with at least 15 minutes dwell time before the procedure.
干预措施: Standard Care for Bladder Botox Injection (Drug)
Sham Mask Plus Standard Care
The sham mask plus standard care group will receive a mask that is connected to the Pro-Nox system but with the valves turned completely off; therefore they will inhale room air plus standard care: intravesical instillation of 1-2% lidocaine solution (30-50 mL) with at least 15 minutes dwell time before the procedure.
干预措施: Sham Mask (Other)
Nitrous Oxide Plus Standard Care
Participants in this group will receive standard care plus 50:50 mix of inhaled nitrous oxide/oxygen self-administered using the Pro-Nox system during the bladder Botox procedure.
干预措施: Pro-Nox Nitrous Oxide/Oxygen Delivery System (Drug)
结局指标
主要结局
Overall Pain (10-point NRS)
时间窗: At least 3 minutes after completion of the procedure.
Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.
次要结局
- Peak Pain (10-point NRS)(At least 3 minutes after completion of the procedure.)
- Peak Pain Timing(At least 3 minutes after completion of the procedure.)
- Overall Anxiety (10-point NRS)(At least 3 minutes after completion of the procedure.)
- Satisfaction with Pain Management (10-point NRS)(At least 3 minutes after completion of the procedure.)
- Willingness to Repeat (5-point Likert)(At least 3 minutes after completion of the procedure.)