No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
Institute for Oncology and Radiology of Serbia · Other
Who this trial is looking for
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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.
Trial Locations
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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 Crit…
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)
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