Actively Recruiting
The 50:50 Nitrous Oxide Challenge: A Prospective Randomised Trial - Needle, Meet Your Match
Led by Institute for Oncology and Radiology of Serbia · Updated on 2026-06-01
62
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain levels and patient comfort during the use of a 50:50 Nitrous Oxide/Oxygen gas mixture compared to the standard practice of injecting a local anesthetic during central venous catheter placement. The study aims to assess how these two methods affect pain and patient experience during the procedure. It is a prospective randomized trial focusing on acute pain, anxiety, and catheter insertion procedures. Participants are randomly assigned to one of two groups: the experimental group receives a mixture of Nitrous Oxide and Oxygen gas through a mask before needle insertion, while the control group receives the standard 2% Lidocaine local anesthetic injection under ultrasound guidance. The procedures include antiseptic preparation, positioning, and catheter placement using the Seldinger technique. The gas mask is used for about five minutes before needle insertion, and Lidocaine is injected five minutes before puncture. During the study, participants will be monitored for pain intensity at needle insertion, catheter placement, and shortly after intervention. Additional measures include anxiety and satisfaction scores collected after the procedure, as well as monitoring for any treatment-related adverse events for 30 minutes post-procedure. The trial involves adults aged 18 to 65 and includes follow-up to assess comfort and safety related to the treatments.
CONDITIONS
Brief Title
The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who have not previously received Nitrous Oxide.
- Subjects of both sexes, aged between 18 and 65 inclusive.
- Subjects who have signed informed consent with full disclosure; no study-related procedure may begin until the subject signs the consent form.
You will not qualify if you...
- Infection at the planned puncture site.
- Pregnancy.
- Intracranial hypertension.
- Vitamin B12 deficiency.
- Hemodynamic instability.
- BMI over 35.
- Glasgow Coma Scale (GCS) score less than 15.
- Presence of chronic pain.
- Neurological disorders.
- Hematologic disorders.
- More than two attempts at venous puncture (Subject Withdrawal Criterion).
- Subject experienced an adverse event requiring early discontinuation (Subject Withdrawal Criterion).
- Withdrawal of consent by the subject (Subject Withdrawal Criterion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants receive either a 50:50 Nitrous Oxide-Oxygen mixture or 2% Lidocaine injection during central venous catheterization to assess pain control efficacy.
1 treatment visit (in-person)
Duration - Up to 30 minutes post-procedure
Participants are monitored for adverse events and assessed for pain, anxiety, and satisfaction up to 30 minutes post-procedure.
1 follow-up visit (in-person) immediately after treatment
Trial Site Locations
Total: 1 location
1
Institute for Oncology and Radiology of Serbia
Belgrade, Savski Venac, Serbia, 11000
Actively Recruiting
Research Team
A
Ana Cvetkovic, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here