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NCT Number: NCT07159425

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

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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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sedation Signs and Symptoms

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for mother and child health care

Belgrade, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Age <1 year or > 16 years
  • Pneumothorax
  • Pneumoperitoneum
  • Pneumocephalus
  • Otitis media
  • Obstructive lung disease
  • Upper airway infection
  • Methylenetetrahydrofolate reductase (MTHF) deficiency
  • Vitamin B12 deficiency
  • Megaloblastic anemia

Treatment and study plan

Primary outcomes

  1. Pain score for children from 1 to 4 years

    Time frame: 5 minutes during the minimal invasive procedure

    Pain assessed using pain scale: 1-4 years using FLAAC (Face, Leg, Activity, Cry and Consolability) pain scale. Pain was categorized as: 0-no pain, 1-3 mild, 4-6 moderate and 7-10 severe

  2. Pain score for children from 4 to 9 years.

    Time frame: 5 minutes during the minimal invasive procedure

    Pain assessed using pain scale: 4-9 years using Wong-Baker Faces Pain Rating Scale. Pain was categorized as: 0-no pain, 1-3 mild, 4-6 moderate and 7-10 severe

  3. Pain score for children from 9 to 16 years

    Time frame: 5 minutes during the minimal invasive procedure

    Pain assessed using pain scale: from 9-16 years using Numeric Rating Scale (NRS) Pain was categorized as: 0-no pain, 1-3 mild, 4-6 moderate and 7-10 severe.

Secondary outcomes

  1. anxiolytic effect

    Time frame: 5 minutes during the minimal invasive procedure

    anxiolytic effect qualified as "cooperative" and "uncooperative"

  2. hypotension

    Time frame: measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%

    drop in noninvasive blood pressure for more than 20mmHg value for age

  3. bradycardia

    Time frame: measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%

    Drop in heart rate measured as beats per minute according to age

  4. desaturation

    Time frame: measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%

    fall of hemoglobine oxygen saturation measured by pulse oximetry SpO2 belov 94%

  5. level of sedation

    Time frame: Assessment will be made at the beginig of applicati

    Level of sedation will be estimated using Ramsay sedation scale. The Ramsay sedation scale is a well-established monitoring method to determine the level of awareness. Points assigned are : 1-Patient anxious, agitated, or restless; 2- Patient cooperative, oriented, or tranquil; 3- Patient responds to commands only; 4- Brisk response to a light glabellar tap or loud auditory stimulus; 5 -Sluggish response to a light glabellar tap or loud auditory stimulus; 6-No response

Sponsors and collaborators

Lead sponsor

Mother and Child Health Institute of Serbia Dr Vukan Cupic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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