Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04571879
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2020-09-10
Brief Title:
Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Nebulized Lidocaine and Intranasal Midazolam for Reducing PainAnxiety of Nasogastric Tube Insertion in Children A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasogastric tube NGT is a commonly performed procedure in the Emergency Department Although it is not a major procedure it is usually associated with a bad experience and cause discomfort and pain in kids This randomized controlled double-blinded double-dummy trial aims to investigate the efficacy of local topical anesthetic andor anxiolysis for painanxiety related to NGT insertion Eligible patients are children with gastroenteritis aged 6 months to 5 years requiring NGT rehydration The intervention are 3 arms of nebulized lidocaine with midazolam compared to nebulized midazolam alone or placebo The primary outcome is procedure-related pain assessment using the Face Legs Activity Cry and Consolability FLACC scale during final NGT insertion attempt
Detailed Description:
Nasogastric tube NGT insertion is commonly performed in the emergency department ED which can cause some painanxiety Shih S and Rosen P 2018 The paindiscomfort related to NGT insertion comes from anxiety gagging and sensitivity of nasopharynx and oropharynx Tapiawala SN et al 2008 Success rate depends on cooperation which limits order for nasogastric tube insertion in most patients especially in non-pediatric hospitals
The pain and anxiety associated with such procedures in kids is a source of noxious stimuli to the nervous system Not only does pain have a negative impact on neurological development but children whose pain has not been adequately treated in infancy or early childhood reported lower pain thresholds as adolescents and adults Ruda MAet al 2000 If not addressed this pain can lead to distress for children their parents and those performing the procedures preprocedural anxiety in the future and can result in negative long-term emotional outcomes Blount RL et al2006 Brewer SG et al 2006
Nebulized 2 lidocaine at doses of 4 and 8 mgkg has shown to be safe in infants and children with all blood levels obtained were well below the toxic range Gjonaj S et al 1997 Nebulized lidocaine in doses up to 8 mgkg appears to be safe and gave statistically significant reduction in pain score when used before flexible bronchoscopy Gjonaj S et al 1997 Nebulizedintranasal lidocaine did not seem to be of benefit when used alone in the two previous trials for NGT insertion in children Babl FE et al2009 Craig SS et al 2019 On the other hand it greatly reduced discomfort associated with NG tube in adult population Cullen L et al 2004 This might be explained by the anxiety and lack of cooperation especially in young kids which might limit the validity of pain score during the whole procedure
Midazolam has a controlled sedation with a quicker recovery time The safety and tolerability profile of midazolam in pediatric patients is comparablesuperior to that observed in adults Pacifici GM 2014 Midazolam is a GABA receptor agonist providing anxiolysis for procedures in pediatric population Midazolam has been shown to be safe and effective for use in children Wilton NC et al1988 Theroux MC et al 1993 Intranasal midazolam has shown improvements with anxiety and crying as well as need for restraint Theroux MC et al 1993 Midazolam anxiolysis has been tried in pediatrics and ordered as nebulization found to have a plasma concentration bioavailability which is comparable to the intranasal midazolam by the ratio nebulizednasal of 129 McCormick AS et al 2008 Clinically effective serum concentrations of intranasal midazolam can be reached within less than 10 min after nasal application Knoester PD et al 2002
Lidocaine Midazolam has been commonly used in different procedures in pediatric emergency department such as urethral catheterization intravenous cannulation lumbar puncture with a great safety margin
The pain and anxiety associated with such procedures in kids is a source of noxious stimuli to the nervous system Not only does pain have a negative impact on neurological development but children whose pain has not been adequately treated in infancy or early childhood reported lower pain thresholds as adolescents and adults Ruda MAet al 2000 If not addressed this pain can lead to distress for children their parents and those performing the procedures preprocedural anxiety in the future and can result in negative long-term emotional outcomes Blount RL et al2006 Brewer SG et al 2006
Nebulized 2 lidocaine at doses of 4 and 8 mgkg has shown to be safe in infants and children with all blood levels obtained were well below the toxic range Gjonaj S et al 1997 Nebulized lidocaine in doses up to 8 mgkg appears to be safe and gave statistically significant reduction in pain score when used before flexible bronchoscopy Gjonaj S et al 1997 Nebulizedintranasal lidocaine did not seem to be of benefit when used alone in the two previous trials for NGT insertion in children Babl FE et al2009 Craig SS et al 2019 On the other hand it greatly reduced discomfort associated with NG tube in adult population Cullen L et al 2004 This might be explained by the anxiety and lack of cooperation especially in young kids which might limit the validity of pain score during the whole procedure
Midazolam has a controlled sedation with a quicker recovery time The safety and tolerability profile of midazolam in pediatric patients is comparablesuperior to that observed in adults Pacifici GM 2014 Midazolam is a GABA receptor agonist providing anxiolysis for procedures in pediatric population Midazolam has been shown to be safe and effective for use in children Wilton NC et al1988 Theroux MC et al 1993 Intranasal midazolam has shown improvements with anxiety and crying as well as need for restraint Theroux MC et al 1993 Midazolam anxiolysis has been tried in pediatrics and ordered as nebulization found to have a plasma concentration bioavailability which is comparable to the intranasal midazolam by the ratio nebulizednasal of 129 McCormick AS et al 2008 Clinically effective serum concentrations of intranasal midazolam can be reached within less than 10 min after nasal application Knoester PD et al 2002
Lidocaine Midazolam has been commonly used in different procedures in pediatric emergency department such as urethral catheterization intravenous cannulation lumbar puncture with a great safety margin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None