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出境医 / 临床实验 / Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children (SONGER)

Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children (SONGER)

Study Description
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.


Condition or disease Intervention/treatment Phase
Mild to Moderate Dehydration Drug: Nitrous Oxide Not Applicable

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
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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).


  3. 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


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Ricardo CARBAJAL, Md, Phd +33144736188 ricardo.carbajal@aphp.fr
Contact: Guillaume Masson, Msc +331 58 41 34 78 guillaume.masson@aphp.fr

Locations
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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         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Investigators
Layout table for investigator information
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
 (submitted: September 2, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Parent's anxiety assessed on a 0 to 10 scale. [ Time Frame: During procedure ]
  • Child's constraint needed during the procedure [ Time Frame: During procedure ]
    Scale for grading the level of constraint during the 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 ]
    The rate of side effects will be described
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
Condition  ICMJE Mild to Moderate Dehydration
Intervention  ICMJE Drug: Nitrous Oxide
Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)
Study Arms  ICMJE
  • Active Comparator: Nitrous oxide
    Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure
    Intervention: Drug: Nitrous Oxide
  • No Intervention: Standard care
    Infants will be reassured as currently performed in routine clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ricardo CARBAJAL, Md, Phd +33144736188 ricardo.carbajal@aphp.fr
Contact: Guillaume Masson, Msc +331 58 41 34 78 guillaume.masson@aphp.fr
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Principal Investigator: Marie Beauchet-Filleau, nurse Trousseau Hospital, pediatric emergency
Study Director: Ricardo Carbajal, Professor Trousseau Hospital, pediatric emergency
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP