Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children (SONGER)
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| ClinicalTrials.gov Identifier: NCT04008628 |
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Recruitment Status :
Recruiting
First Posted : July 5, 2019
Last Update Posted : February 3, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mild to Moderate Dehydration | Drug: Nitrous Oxide | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | The primary outcome will be assessed on video recordings of the procedures which will be prepared so that assessors will not know to which group the children assigned. This correspond to a blind assessment of the primary outcome. |
| Primary Purpose: | Treatment |
| Official Title: | Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years |
| Actual Study Start Date : | December 10, 2021 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Nitrous oxide
Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure
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Drug: Nitrous Oxide
Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®) |
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No Intervention: Standard care
Infants will be reassured as currently performed in routine clinical practice
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- 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).
- Parent's anxiety 10 scale. [ Time Frame: During procedure ]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
- Child's constraint needed during the procedure [ Time Frame: During 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).
- 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 ]The rate of side effects will be described
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| Ages Eligible for Study: | 3 Months to 3 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Vital emergency.
- Refusal of parents.
- Refusal of parents to be 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.
- 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
Premature discontinuation of study participation :
- Parents' request to stop participating in the study.
- Insertion of the nasogastric tube is not possible
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008628
| Contact: Ricardo CARBAJAL, Md, Phd | +33144736188 | ricardo.carbajal@aphp.fr | |
| Contact: Guillaume Masson, Msc | +331 58 41 34 78 | guillaume.masson@aphp.fr |
| France | |
| Trousseau Hospital, Pediatric emergency department | Recruiting |
| Paris, Ile De France, France, 75012 | |
| Contact: Lucie Touchard, nurse luci.touchard@aphp.fr | |
| Principal Investigator: Ricardo CARBAJAL, MD, PhD | |
| Poissy Hospital, Pediatric emergency department | Recruiting |
| Poissy, Ile De France, France, 78300 | |
| Contact: Isabelle BADIER, MD +33 1 39 27 55 91 badier.isa@gmail.com | |
| Principal Investigator: Isabelle BADIER, MD | |
| Ambroise Paré hospital, Pediatric emergency department | Not yet recruiting |
| Boulogne-Billancourt, France, 92100 | |
| Contact: Valérie SOUSSAN-BANINI, MD valerie.soussan-banini@aphp.fr | |
| Principal Investigator: Valérie SOUSSAN-BANINI, MD | |
| Louis Mourier Hospital, Pediatric emergency department | Recruiting |
| Colombes, France, 92700 | |
| Contact: Romain BASMACI, MD romain.basmaci@aphp.fr | |
| Principal Investigator: Romain BASMACI, MD | |
| Principal Investigator: | Marie Beauchet-Filleau, nurse | Trousseau Hospital, pediatric emergency | |
| Study Director: | Ricardo Carbajal, Professor | Trousseau Hospital, pediatric emergency |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT04008628 |
| Other Study ID Numbers: |
PHRIP18164 |
| First Posted: | July 5, 2019 Key Record Dates |
| Last Update Posted: | February 3, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Pain nasogastric tube children |
infants analgesia nitrous oxide |
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Dehydration Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes Nitrous Oxide Anesthetics, Inhalation Anesthetics, General |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |