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Completed
NCT07618676
The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge
Conditions: Acute Pain, Anxiety, Central Venous Catheter
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 62
Sponsor: Institute for Oncology and Radiology of Serbia
Location: Institute for Oncology and Radiology of Serbia Belgrade Savski Venac
Summary
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.
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.
* Systemic or intrathecal methotrexate therapy
* 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)
Source: ClinicalTrials.gov (NCT07618676). StuddyBuddy aggregates publicly available trial information.