A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections

Официальное название

A Randomized, Placebo Controlled Trial of Nitrous Oxide/Oxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Pro-Nox Nitrous Oxide/Oxygen Delivery System
  The Pro-Nox system delivers a fixed 50:50 mixture of nitrous oxide and oxygen for patient self-administered inhaled analgesia. Participants will self-administer nitrous oxide throughout the in-office bladder Botox procedure.
• Препарат Standard Care for Bladder Botox Injection
  Standard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure.
• Другое Sham Mask
  The Sham Mask will involve that participant using the same mask as that of the Nitrous Oxide group, but connected to a Pro-Nox system that is turned completely off. They will therefore receive room air through the mask.

Первичные конечные точки

• Overall Pain (10-point NRS) [Срок оценки: At least 3 minutes after completion of the procedure.]

Вторичные конечные точки (5)

• Peak Pain (10-point NRS) [Срок оценки: At least 3 minutes after completion of the procedure.]
• Peak Pain Timing [Срок оценки: At least 3 minutes after completion of the procedure.]
• Overall Anxiety (10-point NRS) [Срок оценки: At least 3 minutes after completion of the procedure.]
• Satisfaction with Pain Management (10-point NRS) [Срок оценки: At least 3 minutes after completion of the procedure.]
• Willingness to Repeat (5-point Likert) [Срок оценки: At least 3 minutes after completion of the procedure.]

Критерии участия

Критерии включения

• Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Cincinnati Urogynecology Associates — Cincinnati
• Trihealth (Good Samaritan Hospital, Bethesda North Hospital) — Cincinnati

Идентификаторы

NCT: NCT07387315 · 23-130

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗