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 |
| Estimated Study Start Date : | September 2021 |
| Estimated Primary Completion Date : | September 2022 |
| Estimated Study Completion Date : | September 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Nitrous oxide
Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure
|
Drug: Nitrous Oxide
Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)
|
|
No Intervention: Standard care
Infants will be reassured as currently performed in routine clinical practice
|
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).
| Ages Eligible for Study: | 3 Months to 3 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Premature discontinuation of study participation :
| 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 | |
| Paris, Ile De France, France, 75012 | |
| Contact: Marie Beauchet-Filleau, nurse marie.beauchet-filleau@aphp.fr | |
| Principal Investigator: Marie Beauchet-Filleau, nurse | |
| Poissy Hospital, Pediatric emergency department | |
| Poissy, Ile De France, France, 78300 | |
| Contact: Marie Beauchet-Filleau, nurse marie.beauchet-filleau@aphp.fr | |
| Principal Investigator: Marie Beauchet-Filleau, nurse | |
| Principal Investigator: | Marie Beauchet-Filleau, nurse | Trousseau Hospital, pediatric emergency | |
| Study Director: | Ricardo Carbajal, Professor | Trousseau Hospital, pediatric emergency |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | May 3, 2021 | ||||||||
| Estimated Study Start Date ICMJE | September 2021 | ||||||||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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).
|
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| Original Primary Outcome Measures ICMJE |
Pain during nasogastric tube insertion: FLACC scale [ 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 FLACC scale. Scale from 0 to 10
|
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children | ||||||||
| Official Title ICMJE | Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years | ||||||||
| Brief 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. 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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
|
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| Condition ICMJE | Mild to Moderate Dehydration | ||||||||
| Intervention ICMJE | Drug: Nitrous Oxide
Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
160 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 2022 | ||||||||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Premature discontinuation of study participation :
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 3 Months to 3 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04008628 | ||||||||
| Other Study ID Numbers ICMJE | PHRIP18164 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||
| Collaborators ICMJE | URC-CIC Paris Descartes Necker Cochin | ||||||||
| Investigators ICMJE |
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| PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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