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

N/AEnrolling By InvitationNCT07159425

Mother and Child Health Institute of Serbia Dr Vukan Cupic300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Pain Anxiety Sedation

Eligibility

Sex: ALLMin age: 1 YearMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 5 minutes during the minimal invasive procedure

Secondary Outcomes

anxiolytic effect

anxiolytic effect qualified as "cooperative" and "uncooperative"

Time frame: 5 minutes during the minimal invasive procedure

hypotension

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

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

bradycardia

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

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

desaturation

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

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

level of sedation

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

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