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

NCT07159425 | Completed DMC

• 1 other identifier: 8/154
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Anxiety; Sedation; Pain

Keywords

pain; anxiety; nitrous oxyde; children

Outcome Measures

Primary Outcomes (3)

• Pain score for children from 1 to 4 years

  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.

  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

  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 Outcomes (5)

• anxiolytic effect

  5 minutes during the minimal invasive procedure

• hypotension

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

• bradycardia

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

• desaturation

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

• level of sedation

  Assessment will be made at the beginig of applicati

Study Arms (1)

Peditric patients planned for minimal invasive procedure

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

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mother and Child Health Institute of Serbia Dr Vukan Cupic: lead

Study Sites (1)

Institute for mother and child health care

Belgrade, Serbia

Location

Related Publications (5)

• Carbajal R, Biran V, Lenclen R, Epaud R, Cimerman P, Thibault P, Annequin D, Gold F, Fauroux B. EMLA cream and nitrous oxide to alleviate pain induced by palivizumab (Synagis) intramuscular injections in infants and young children. Pediatrics. 2008 Jun;121(6):e1591-8. doi: 10.1542/peds.2007-3104. Epub 2008 May 5.

  PMID: 18458035 BACKGROUND

• Ekbom K, Jakobsson J, Marcus C. Nitrous oxide inhalation is a safe and effective way to facilitate procedures in paediatric outpatient departments. Arch Dis Child. 2005 Oct;90(10):1073-6. doi: 10.1136/adc.2004.060319.

  PMID: 16177164 BACKGROUND

• Zier JL, Liu M. Safety of high-concentration nitrous oxide by nasal mask for pediatric procedural sedation: experience with 7802 cases. Pediatr Emerg Care. 2011 Dec;27(12):1107-12. doi: 10.1097/PEC.0b013e31823aff6d.

  PMID: 22134227 BACKGROUND

• Fein D, Avner JR, Khine H. Pattern of pain management during lumbar puncture in children. Pediatr Emerg Care. 2010 May;26(5):357-60. doi: 10.1097/PEC.0b013e3181db2026.

  PMID: 20404782 BACKGROUND

• Milesi C, Pidoux O, Sabatier E, Badr M, Cambonie G, Picaud JC. Nitrous oxide analgesia for intubating preterm neonates: a pilot study. Acta Paediatr. 2006 Sep;95(9):1104-8. doi: 10.1080/08035250600698818.

  PMID: 16938758 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Ana Mandras, PhD

  Institute for mother and child health care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: September 8, 2025
• Study Start: October 3, 2024
• Primary Completion: January 3, 2026
• Study Completion: January 3, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)