The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge
Recruiting · NCT07618676 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute for Oncology and Radiology of Serbia
View the official record on ClinicalTrials.gov →Interventions studied
Lidocaine 2% Injectable SolutionNitrous Oxide-Oxygen
What this trial is about
The main goal of the project is to assess pain levels and patient comfort during the administration of a 50:50 Nitrous Oxide/Oxygen gas mixture, in comparison to the same parameters under the standard method used at our institution, which includes injecting a local anaesthetic at the site of planned puncture for central venous catheterisation.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Where it is running
1 location listed.
- Institute for Oncology and Radiology of Serbia - Belgrade, Savski Venac, Serbia