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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peditric patients planned for minimal invasive procedure | Patients who will be sedated using oxygen:nitrogen suboxide 50%:50% gas mixture for minimal invasive procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| anxiolytic effect | anxiolytic effect qualified as "cooperative" and "uncooperative" | 5 minutes during the minimal invasive procedure |
| hypotension | drop in noninvasive blood pressure for more than 20mmHg value for age |
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Inclusion Criteria:
Exclusion Criteria:
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single tertiray center random-sample cohort of pediatric patients undergoing any in-hospital minor invasive procedure during a continuous 12 months period of recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Ana Mandras, PhD | Institute for mother and child health care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for mother and child health care | Belgrade | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18458035 | Background | 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. | |
| 16177164 | Background |
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In order to protect individual patients data IPD will not br shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2024 | Aug 28, 2025 |
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| 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 | 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% | 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 | Assessment will be made at the beginig of applicati |
| 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. |
| 22134227 | 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. |
| 20404782 | 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. |
| 16938758 | 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. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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