Nitrous Oxide for Pain During Bladder Botox Injections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a mix of nitrous oxide (often called "laughing gas") and oxygen can reduce pain during bladder Botox injections. Researchers aim to determine if this gas makes the procedure less painful compared to standard pain relief methods. Participants will receive either the nitrous oxide mix or a placebo (a fake treatment) along with standard care during their injection. Women scheduled for bladder Botox injections who can understand and agree to the trial might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients, offering participants a chance to contribute to broader medical knowledge.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the Pro-Nox Nitrous Oxide/Oxygen Delivery System?
Research has shown that the Pro-Nox system, which uses an equal mix of nitrous oxide and oxygen, is safe for patients. The FDA has approved it for managing pain during cosmetic procedures, indicating it has undergone safety testing in various situations. Patients control how much gas they inhale, adding an extra layer of safety. While side effects can occur with any treatment, Pro-Nox is usually well-tolerated. No major reports of serious problems have emerged with its use.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about the use of the Pro-Nox Nitrous Oxide/Oxygen Delivery System for pain management during bladder Botox injections because it offers a potentially more comfortable experience. Unlike traditional options, which often rely solely on lidocaine to numb the bladder area, this treatment allows patients to self-administer a 50:50 mix of nitrous oxide and oxygen, offering rapid pain relief. The nitrous oxide acts quickly and wears off fast, providing an effective and convenient alternative to simply waiting for traditional anesthetics to take effect. This method could significantly enhance patient comfort during the procedure.
What evidence suggests that nitrous oxide is effective for pain during bladder Botox injections?
Research has shown that the Pro-Nox system, which delivers a mix of nitrous oxide and oxygen, can reduce pain during medical procedures. This 50/50 mix relaxes patients and lessens discomfort. In this trial, participants in the "Nitrous Oxide Plus Standard Care" arm will self-administer this mix during bladder Botox procedures. Patients can control their pain levels, obtaining quick relief from pain and anxiety. This is particularly beneficial during procedures like bladder Botox injections. Many years of research support the use of nitrous oxide for fast pain relief without long-term side effects. The trial aims to confirm these benefits specifically for bladder procedures.13567
Are You a Good Fit for This Trial?
This trial is for adult women over 18 who are scheduled to receive Botox injections in the bladder for conditions like overactive bladder and urinary incontinence. They must be able to consent to the procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bladder Botox injections with either nitrous oxide/oxygen or sham mask plus standard care
Immediate Post-procedure Assessment
Participants report on pain, anxiety, satisfaction, and willingness to repeat the procedure
Follow-up
Participants are monitored for any adverse effects and overall outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Pro-Nox Nitrous Oxide/Oxygen Delivery System
Trial Overview
The study tests if a mix of nitrous oxide and oxygen can reduce pain during bladder Botox injections compared to standard care with a sham mask. Participants will answer questions about their pain and satisfaction levels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
TriHealth Inc.
Lead Sponsor
Citations
A Randomized, Placebo-controlled Trial of Nitrous Oxide ...
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.
Pro-Nox™ Nitrous Oxide System - Richmond
With a 50/50 mixture of nitrous oxide and oxygen, the Pro-Nox system can help you relax and minimize pain during your medical spa treatment.
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ctv.veeva.com
ctv.veeva.com/study/a-randomized-placebo-controlled-trial-of-nitrous-oxide-during-in-office-bladder-botox-injectionsA Randomized, Placebo-controlled Trial of Nitrous Oxide ...
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.
Pro-Nox In West Palm Beach
The Pro-Nox™ delivery system was developed for use in aesthetic procedures as a unique inhalation tool allowing patients to control their own discomfort level ...
Pro-Nox™
Based on decades of extensive research and proven success, a 50/50 mixture of nitrous oxide provides short-term pain, anxiety, and stress relief-without causing ...
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carestreamamerica.com
carestreamamerica.com/wp-content/uploads/2021/05/ProNoxWhite-2-ASLMS-2021.pdfsafety of a novel nitrous oxide delivery system to provide ...
• Pro-Nox is a novel nitrous oxide delivery system. • Provides patient analgesia during cosmetic procedures. • Cleared by FDA as an analgesic device.
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sigma.larvol.com
sigma.larvol.com/company.php?e1=10861&e2=&sourcepg=TZC&tab=OTTtrac&sr=now&er=1+month&ipwnd=on&rlink=,tab=OTTtrac,sourcepg=TZC,itype=0,1&rflag=1&page=24AbbVie Trials
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