The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge

Institute for Oncology and Radiology of Serbia

Status: Enrolling

Conditions: Anxiety; Acute Pain; Central Venous Catheter

Treatments: Drug: Lidocaine 2% Injectable Solution; Drug: Nitrous Oxide-Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT07618676

01-1/2025/1264

Details and patient eligibility

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Nitrous Oxide Group

Experimental group

Description:

This will be the experimental group in which the patients will receive a mixture of gases to assess the efficacy of the treatment compared to the control.

Treatment:

Drug: Nitrous Oxide-Oxygen

Lidocaine 2%

Active Comparator group

Description:

The control group receiving the standard of care for this intervention.

Treatment:

Drug: Lidocaine 2% Injectable Solution