PainNCT07159425
Estimation of Analgetic Effect and Cooperability of Pediatric Patients During Application of Gass Mixture of Oxygen:Nitrogen Suboxide 50%:50% for Minimal Invasive Procedures
An observational study of Pain and Anxiety, run by Mother and Child Health Institute of Serbia Dr Vukan Cupic at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- 3 Oct 2024to 3 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- Age <1 year or > 16 years
- Pneumothorax
- Pneumoperitoneum
- Pneumocephalus
- Otitis media
- Obstructive lung disease
Show all 10Show fewer
- Upper airway infection
- Methylenetetrahydrofolate reductase (MTHF) deficiency
- Vitamin B12 deficiency
- Megaloblastic anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Keywords
- pain, anxiety, nitrous oxyde, children
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 5 minutes during the minimal invasive procedure
Secondary outcomes (5)
anxiolytic effect
anxiolytic effect qualified as "cooperative" and "uncooperative"
Measured: 5 minutes during the minimal invasive procedure
hypotension
drop in noninvasive blood pressure for more than 20mmHg value for age
Measured: 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: 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: 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
Measured: Assessment will be made at the beginig of applicati
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start3 Oct 2024
- Primary completion3 Jan 2026
- Study completion3 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mother and Child Health Institute of Serbia Dr Vukan Cupic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Mandras, Mother and Child Health Institute of Serbia Dr Vukan Cupic
- Investigators
- Ana Mandras, PhD, Principal investigator, Institute for mother and child health care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159425
- Sponsor's protocol ID
- 8/154
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No: In order to protect individual patients data IPD will not br shared
Publications
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.
PubMed 18458035Ekbom 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.
PubMed 16177164Zier 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.
PubMed 22134227Fein 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.
PubMed 20404782Milesi 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.
PubMed 16938758
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Analgetic Effect and Cooperability of Pediatric Patients During Application of Gaseous Mixture of Oxygen:Nitrogen Suboxide 50%:50% for Minimal Invasive Procedures
- ClinicalTrials.gov ID
- NCT07159425
- Acronym / sponsor ID
- 8/154
- Keywords
- pain, anxiety, nitrous oxyde, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mother and Child Health Institute of Serbia Dr Vukan CupicUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 3 Jan 2026 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peditric patients planned for minimal invasive procedure | – | –Patients who will be sedated using oxygen:nitrogen suboxide 50%:50% gas mixture for minimal invasive procedure |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- Age <1 year or > 16 years
- Pneumothorax
- Pneumoperitoneum
- Pneumocephalus
- Otitis media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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 secondary outcomes
anxiolytic effect
Time frame: 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%
bradycardia
Time frame: 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%
level of sedation
Time frame: Assessment will be made at the beginig of applicati
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 18458035Carbajal 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.
- Background: PubMed 16177164Ekbom 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.
- Background: PubMed 22134227Zier 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.
- Background: PubMed 20404782Fein 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.
- Background: PubMed 16938758Milesi 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.
- Individual participant dataSharing planned: No. In order to protect individual patients data IPD will not br shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Mandras, PhD principal investigator
Institute for mother and child health care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by Mother and Child Health Institute of Serbia Dr Vukan Cupic at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score for children from 1 to 4 years (time frame: 5 minutes during the minimal invasive procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07159425, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.