Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children
Study Details
Study Description
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 and/or anxiolysis for pain/anxiety 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Nasogastric tube (NGT) insertion is commonly performed in the emergency department (ED) which can cause some pain/anxiety [Shih S and Rosen P, 2018]. The pain/discomfort 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 M.A.et 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 R.L et al,2006; Brewer S.G. et al, 2006].
Nebulized 2% lidocaine at doses of 4 and 8 mg/kg 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 mg/kg appears to be safe and gave statistically significant reduction in pain score when used before flexible bronchoscopy [Gjonaj S et al, 1997]. Nebulized/intranasal lidocaine did not seem to be of benefit when used alone in the two previous trials for NGT insertion in children [Babl FE et al,2009; 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 comparable/superior 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 al,1988; 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 (nebulized:nasal) of 1:2.9. [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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 Nebulized 2% lidocaine hydrochloride 4 mg/kg to be delivered via nebulization (up to a maximum of 15 ml) and given over ½ hr. Intranasal midazolam 0.5 mg/kg delivered via intranasal atomization (up to a maximum of 10 mg). |
Drug: Nebulized Lidocaine
Nebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children
Other Names:
Drug: Intranasal Midazolam
Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion
Other Names:
|
| Experimental: Arm 2 Intranasal midazolam 0.5 mg/kg to be delivered via intranasal atomization (up to a maximum of 10 mg). Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr. |
Drug: Intranasal Midazolam
Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion
Other Names:
|
| Placebo Comparator: Arm 3 Intranasal placebo (normal saline) in a volume comparable to midazolam 0.5 ml/kg to be delivered via intranasal atomization Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr. |
Other: Placebo
Nebulized normal saline and intranasal normal sline
|
Outcome Measures
Primary Outcome Measures
- Pain severity rating scale (FLACC) during insertion of NGT. [1 year]
score from 0 to 10. Higher scores mean worse outcome
Secondary Outcome Measures
- Observer/caregiver pain severity rating: [1 year]
Score from 1 to 100. Higher scores mean worse outcome
- The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion. [1 year]
Score from 1 to 5. Higher scores mean worse outcome
- The number of attempts required to successfully insert the NGT [1 year]
The number of attempts of successful NGT insertion
- Procedural complications/adverse events. [1 year]
Records complications and adverse effects
- FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion. [up to 180 minutes]
Scores from 0 to 10. Higher scores mean worse outcome
- Length of stay in ED [up to 180 minutes]
Length of stay in minutes
- Duration of NGT feed. [up to 180 minutes]
The observer records data on chart
- Tolerated volume of NGT feed. [1 year]
Amount of fluid (ml)
Eligibility Criteria
Criteria
Inclusion Criteria:
1 Previously healthy children 6 months to 5 years old presenting with AGE and some dehydration who were planned to have a nasogastric tube inserted as part of their ED treatment.
Exclusion Criteria:
-
Indication for an urgent insertion of a nasogastric tube.
-
Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
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.Patients allergic to midazolam or lidocaine.
-
.Congenital Heart disease or arrhythmia.
-
.Known hepatic or renal impairment
-
.Developmentally abnormal children
-
.Patients with seizure disorder
-
.Pre-existing abnormal neurological conditions
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.Child is taking medications known to interact with lidocaine and/or midazolam (antiarrhythmic drugs, suxamethonium, phenytoin, antidepressants, propranolol, citicoline).
-
.Known case of severe gastroesophageal reflux disease or aspiration pneumonia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pediatric Emergency Center, Hamad Medical Corporation | Doha | Qatar | 3050 | |
| 2 | Sidra Medicine | Doha | Qatar | 3050 |
Sponsors and Collaborators
- Hamad Medical Corporation
Investigators
- Principal Investigator: Fatihi Toaimah, MD, PhD, Hamad Medical Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MRC-01-19-442