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Compares treatment options for Acute Pain
Official title The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge
ClinicalTrials.gov ID: NCT07618676
What this study is testing
What is Nitrous Oxide-Oxygen?
Nitrous Oxide-Oxygen is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for acute pain.
Also referred to as Experimental Treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- people who have not previously received Nitrous Oxide.
- people of both sexes, aged between 18 and 65 inclusive.
- people who have signed informed consent with full disclosure; no study-related procedure may begin until the subject signs the consent form.
You likely can't join if
- Infection at the planned puncture site.
- Pregnancy.
- Intracranial hypertension.
- Vitamin B12 deficiency.
- Hemodynamic instability.
- BMI over 35.
See the full eligibility criteria
- people who have not previously received Nitrous Oxide.
- people of both sexes, aged between 18 and 65 inclusive.
- people who have signed informed consent with full disclosure; no study-related procedure may begin until the subject signs the consent form.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Belgrade, Savski Venac, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belgrade, Savski Venac, Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.