Estimation of Analgetic Effect and Cooperability of Pediatric Patients During Application of Gass Mixture of Oxygen:Nitrogen Suboxide 50%:50% for Minimal Invasive Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-03

Study Completion Date

2026-01-03

Brief Summary

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The goal of this observational study is to observe analgetic and anxiolytic effect of gass mixture of oxygen:nitrigen suboxide 50%:50% in pediatric patients sujected to minimal invasive procedures. The main question it aims to answer is: Does gass mixture of oxygen:nitrigen suboxide 50%:50% has effective anxyolitic and analgetic properties for minimal inavsive procedures in pediatric patients?

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Detailed Description

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Conditions

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Pain Anxiety Sedation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peditric patients planned for minimal invasive procedure

Patients who will be sedated using oxygen:nitrogen suboxide 50%:50% gas mixture for minimal invasive procedure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1 Age 1-16 years 2 Veinpuncture 3 Arterial line placement 4 Nasogastric tube placement 5 Urinary catheter placement 6 Removal of thoracic drain 7 Skin suture

Exclusion Criteria

1. Age \<1 year or \> 16 years
2. Pneumothorax
3. Pneumoperitoneum
4. Pneumocephalus
5. Otitis media
6. Obstructive lung disease
7. Upper airway infection
8. Methylenetetrahydrofolate reductase (MTHF) deficiency
9. Vitamin B12 deficiency
10. Megaloblastic anemia

Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes