Anxiety, Pain, Sedation
Conditions
Keywords
pain, anxiety, nitrous oxyde, children
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?
Interventions
None listed
Sponsors
Mother and Child Health Institute of Serbia Dr Vukan Cupic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score for children from 1 to 4 years | 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 |
| Pain score for children from 4 to 9 years. | 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 |
| Pain score for children from 9 to 16 years | 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
| Measure | Time frame | Description |
|---|---|---|
| anxiolytic effect | 5 minutes during the minimal invasive procedure | anxiolytic effect qualified as "cooperative" and "uncooperative" |
| hypotension | 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 |
| bradycardia | 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 |
| desaturation | 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% |
| level of sedation | 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 |
Countries
Serbia
Contacts
PRINCIPAL_INVESTIGATORAna Mandras, PhD
Institute for mother and child health care
Outcome results
None listed