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

March 16, 2026 updated by: Ana Mandras, Mother and Child Health Institute of Serbia Dr Vukan Cupic

Estimation of Analgetic Effect and Cooperability of Pediatric Patients During Application of Gaseous 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?

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia
        • Institute for mother and child health care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

single tertiray center random-sample cohort of pediatric patients undergoing any in-hospital minor invasive procedure during a continuous 12 months period of recruitment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Peditric patients planned for minimal invasive procedure
Patients who will be sedated using oxygen:nitrogen suboxide 50%:50% gas mixture for minimal invasive procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes during the minimal invasive procedure
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
5 minutes during the minimal invasive procedure
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.
5 minutes during the minimal invasive procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiolytic effect
Time Frame: 5 minutes during the minimal invasive procedure
anxiolytic effect qualified as "cooperative" and "uncooperative"
5 minutes during the minimal invasive procedure
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
measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%
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
measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%
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%
measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%
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
Assessment will be made at the beginig of applicati

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mother and Child Health Institute of Serbia Dr Vukan Cupic

Investigators

  • Principal Investigator: Ana Mandras, PhD, Institute for mother and child health care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Actual)

January 3, 2026

Study Completion (Actual)

January 3, 2026

Study Registration Dates

First Submitted

April 12, 2025

First Submitted That Met QC Criteria

August 28, 2025

First Posted (Actual)

September 8, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8/154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to protect individual patients data IPD will not br shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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