Mild to Moderate DehydrationSONGERNCT04008628
Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children
A study testing Nitrous Oxide in people with Mild to Moderate Dehydration, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Mild to Moderate Dehydration
- What is being tested?
- Nitrous Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Dec 2021to 22 Aug 2023
- Phase
- Interventional
- 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 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child from 3 months to 3 years old.
- Admission to the Pediatric Emergency Department
- Medical prescription for the insertion of a nasogastric tube.
- Child with gastroenteritis and / or bronchiolitis and / or food intolerance with mild to moderate dehydration
- Parental presence and parental consent
Who cannot join
- Vital emergency.
- Refusal of parents to be filmed or to have their child filmed.
- Child already included in the study or in course of participation in another study.
- Tube placement performed by a medical student or nursing student.
- Patient requiring 100% oxygen ventilation.
- No social security.
Show all 21Show fewer
- Child with a mental handicap or known retardation.
- History of child intolerance to Nitrous oxide ( excessive sedation or respiratory depression during previous use).
- Child with head trauma in the previous 3 days.
- Child with new-onset neurological abnormalities or other altered states of consciousness.
- Child with intracranial hypertension.
- Child with pneumothorax
- Child having received in the last 3 months prior to inclusion an ophthalmic gas ( SF6, C3F8, C2F6)
- Child with known vitamin B12 deficiency or unsubstituted folic acid.
- Child who has had a diving accident.
- Child with abdominal gas distension abdominal
- Child with gas embolism
- Child with pulmonary emphysema
- Premature discontinuation of study participation :
- Parents' request to stop participating in the study.
- Insertion of the nasogastric tube is not possible
Trial locations and contacts
4 sites in 1 country.
France4 sites
Ambroise Paré hospital, Pediatric emergency department
Boulogne-Billancourt, 92100
Louis Mourier Hospital, Pediatric emergency department
Colombes, 92700
Trousseau Hospital, Pediatric emergency department
Paris, Île-de-France Region, 75012
Poissy Hospital, Pediatric emergency department
Poissy, Île-de-France Region, 78300
About this study
Official title: Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years
Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.
The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.
Read the detailed description
In the context of mild to moderate dehydration in young children, enteral rehydration is the treatment of choice because it is more physiological than parenteral rehydration which has more serious side effects. Thus, nasogastric tube placement has become a more common procedure in the pediatric emergency care setting. Although, it is widely accepted that this procedure is invasive and painful, to date, no analgesic approach has been shown to be effective for children aged 3 months to 3 years. Currently, standard care is the placement of nasogastric tube without any analgesic intervention.
Inhalation of nitrous oxide mixed with oxygen (50/50) has been shown to be effective to reduce pain and anxiety induced by invasive procedures in children, adolescents and adults. Its use is very safe and it is associated with only minor and transient side effects such as nausea, vomiting or dizziness in les than 10% of patients. Its use is very common in many countries such as France, United Kingdom, The Netherlands or Australia. The investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.
The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.
A randomized controlled trial will be performed in two pediatric emergency departments to assess the efficacy of 50/50 nitrous oxide/oxygen during nasogastric tube insertion. The control group will receive standard care.
Primary outcome: Pain assessed with the FLACC scale during tube insertion
The investigators believe that this randomized study comparing nitrous oxide inhalation against current practice (no analgesic means) will highlight the intensity of pain caused by nasogastric tube placement and will assess the effectiveness of nitrous oxide inhalation to reduce pain and anxiety induced by the procedure
- Conditions
- Mild to Moderate Dehydration
- Being tested
- Nitrous Oxide
- Keywords
- Pain, nasogastric tube, children, infants, analgesia, nitrous oxide
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)
| Study group | Role | What they receive |
|---|---|---|
| Nitrous oxide | Active comparator | Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure Receives: Drug: Nitrous Oxide |
| Standard care | No intervention | Infants will be reassured as currently performed in routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during nasogastric tube insertion
Pain will be assessed during nasogastric tube insertion with the Face Legs Activity Cry Consolability (FLACC) scale composed of five scale (face, legs, activities, shouting, consolability). Each ranks from 0 to 2 : 0 is no pain, 1 is average pain, 2 is a strong pain The outcome measure is the sum of these five subscales: from 0 (better outcome) to 10 (worse outcome).
Measured: From the beginning of the procedures until 2 minutes after final positioning of the tube
Secondary outcomes (3)
Parent's anxiety 10 scale.
The parent evaluates himself his anxiety. It's a simple scale graduate one by one, from 0 (better outcome) to 10 (worse outcome). Based on their subjective interpretation of their own anxiety
Measured: During procedure
Child's constraint needed during the procedure
Scale for grading the level of constraint during the procedure It is composed to three subscales from 0 to 3 (head, arms, legs). 0 is no contention, 1 is soft hold, 2 is firm support, 3 is very firm hold And one subscale from 0 to 1 (trunk). 0 is no contention, 1 is necessary maintenance.
The outcome measure is the sum of these four subscales: from 0 (better outcome, that is to say no contention) to 10 (strongest contention).
Measured: During procedure
The potential side effects of the mixture 50%/50% nitrous oxide/oxygen for a brief inhalation are : Euphoria, dreaming, hallucinations, sedation, headaches, nausea, and vomiting.
The rate of side effects will be described
Measured: from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start10 Dec 2021
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate DehydrationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie Beauchet-Filleau, nurse, Principal investigator, Trousseau Hospital, pediatric emergencyRicardo Carbajal, Professor, Study director, Trousseau Hospital, pediatric emergency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008628
- Sponsor's protocol ID
- APHP190210
- Acronym
- SONGER
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years
- ClinicalTrials.gov ID
- NCT04008628
- Acronym / sponsor ID
- SONGER / APHP190210
- Conditions
- Mild to Moderate Dehydration
- Keywords
- Pain, nasogastric tube, children, infants, analgesia, nitrous oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 5 Jul 2019 (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.
Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.
The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.
Detailed description
In the context of mild to moderate dehydration in young children, enteral rehydration is the treatment of choice because it is more physiological than parenteral rehydration which has more serious side effects. Thus, nasogastric tube placement has become a more common procedure in the pediatric emergency care setting. Although, it is widely accepted that this procedure is invasive and painful, to date, no analgesic approach has been shown to be effective for children aged 3 months to 3 years. Currently, standard care is the placement of nasogastric tube without any analgesic intervention.
Inhalation of nitrous oxide mixed with oxygen (50/50) has been shown to be effective to reduce pain and anxiety induced by invasive procedures in children, adolescents and adults. Its use is very safe and it is associated with only minor and transient side effects such as nausea, vomiting or dizziness in les than 10% of patients. Its use is very common in many countries such as France, United Kingdom, The Netherlands or Australia. The investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.
The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.
A randomized controlled trial will be performed in two pediatric emergency departments to assess the efficacy of 50/50 nitrous oxide/oxygen during nasogastric tube insertion. The control group will receive standard care.
Primary outcome: Pain assessed with the FLACC scale during tube insertion
The investigators believe that this randomized study comparing nitrous oxide inhalation against current practice (no analgesic means) will highlight the intensity of pain caused by nasogastric tube placement and will assess the effectiveness of nitrous oxide inhalation to reduce pain and anxiety induced by the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrous oxide | Active comparator | Drug: Nitrous OxideInhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure |
| Standard care | No intervention | –Infants will be reassured as currently performed in routine clinical practice |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child from 3 months to 3 years old.
- Admission to the Pediatric Emergency Department
- Medical prescription for the insertion of a nasogastric tube.
- Child with gastroenteritis and / or bronchiolitis and / or food intolerance with mild to moderate dehydration
- Parental presence and parental consent
Key exclusion criteria (21 listed)
- Vital emergency.
- Refusal of parents to be filmed or to have their child filmed.
- Child already included in the study or in course of participation in another study.
- Tube placement performed by a medical student or nursing student.
- Patient requiring 100% oxygen ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous OxideInhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®) | Drug | Nitrous oxide |
Primary outcome
Pain during nasogastric tube insertion
Time frame: From the beginning of the procedures until 2 minutes after final positioning of the tube
Pain will be assessed during nasogastric tube insertion with the Face Legs Activity Cry Consolability (FLACC) scale composed of five scale (face, legs, activities, shouting, consolability). Each ranks from 0 to 2 : 0 is no pain, 1 is average pain, 2 is a strong pain The outcome measure is the sum of these five subscales: from 0 (better outcome) to 10 (worse outcome).
3 secondary outcomes
Parent's anxiety 10 scale.
Time frame: During procedure
Child's constraint needed during the procedure
Time frame: During procedure
The potential side effects of the mixture 50%/50% nitrous oxide/oxygen for a brief inhalation are : Euphoria, dreaming, hallucinations, sedation, headaches, nausea, and vomiting.
Time frame: from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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.
Marie Beauchet-Filleau, nurse principal investigator
Trousseau Hospital, pediatric emergency
Ricardo Carbajal, Professor study director
Trousseau Hospital, pediatric emergency
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous Oxide in people with Mild to Moderate Dehydration, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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 5 inclusion and 21 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 during nasogastric tube insertion (time frame: From the beginning of the procedures until 2 minutes after final positioning of the tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.