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Recruiting NCT07618676

The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge

No phase Interventional Acute Pain Anxiety Central Venous Catheter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitrous Oxide-Oxygen, Lidocaine 2% Injectable Solution.
Who it may be relevant to
Registry conditions: Acute Pain, Anxiety, Central Venous Catheter. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The 50:50 Nitrous Oxide Challenge: A Prospective Randomised Trial - Needle, Meet Your Match

Overview

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.

Interventions

  • Drug Nitrous Oxide-Oxygen
    After placing the patient in the appropriate supination + Trendelenburg position, the operative field (neck and subclavian region) is prepared using antiseptic measures.Five minutes before needle insertion, a mask connected to a 50:50 Nitrous Oxide/Oxygen cylinder with a flow rate of 6 liters per minute is placed on the patient's face and held by the patient. The mask has a valve that opens only when the patient creates negative pressure during inhalation.The patient is instructed to breathe spo
  • Drug Lidocaine 2% Injectable Solution
    After placing the patient in the appropriate supination + Trendelenburg position, the operative field (neck and subclavian region) is prepared using antiseptic measures. Then, under ultrasound control, the most favorable central vein for puncture is determined (v. jugularis interna or v. subclavia) and a 25-gauge needle is used to infiltrate the skin and subcutaneous tissue above the selected vein with local anesthetic. Five minutes after infiltration, puncture of the selected vein is performed

Primary outcome measures

  • Pain Intensity During Needle Insertion [Time frame: At the time of needle insertion]
  • Pain Intensity During Catheter Placement [Time frame: During catheter placement]
  • Pain Intensity Post-Intervention [Time frame: 2 minutes after gas inhalation (Treatment 1) or 2 minutes post-intervention (Treatment 2)]
Secondary outcome measures (3)
  • Patient Anxiety Score [Time frame: Post-intervention (at the conclusion of the central venous catheterization procedure)]
  • Patient Satisfaction Score [Time frame: Post-intervention (at the conclusion of the central venous catheterization procedure)]
  • Incidence of Treatment-Related Adverse Events [Time frame: From the start of the intervention through 30 minutes post-procedure]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Serbia · 1 center
  • Institute for Oncology and Radiology of Serbia — Belgrade

Identifiers

NCT: NCT07618676 · 01-1/2025/1264

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗