Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children

March 1, 2023 updated by: Hamad Medical Corporation

Nebulized Lidocaine and Intranasal Midazolam for Reducing Pain/Anxiety of Nasogastric Tube Insertion in Children: A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Recruiting
        • Pediatric Emergency Center, Hamad Medical Corporation
        • Contact:
          • Fatihi Toaimah
      • Doha, Qatar, 3050
        • Not yet recruiting
        • Sidra Medicine
        • Contact:
          • Khalid Alansari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Indication for an urgent insertion of a nasogastric tube.
  2. Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
  3. .Patients allergic to midazolam or lidocaine.
  4. .Congenital Heart disease or arrhythmia.
  5. .Known hepatic or renal impairment
  6. .Developmentally abnormal children
  7. .Patients with seizure disorder
  8. .Pre-existing abnormal neurological conditions
  9. .Child is taking medications known to interact with lidocaine and/or midazolam (antiarrhythmic drugs, suxamethonium, phenytoin, antidepressants, propranolol, citicoline).
  10. .Known case of severe gastroesophageal reflux disease or aspiration pneumonia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Nebulized Xylocaine
Drug: Intranasal Midazolam
Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion
Other Names:
  • IN Midazolam
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:
  • IN Midazolam
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity rating scale (FLACC) during insertion of NGT.
Time Frame: 1 year
score from 0 to 10. Higher scores mean worse outcome
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observer/caregiver pain severity rating:
Time Frame: 1 year
Score from 1 to 100. Higher scores mean worse outcome
1 year
The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion.
Time Frame: 1 year
Score from 1 to 5. Higher scores mean worse outcome
1 year
The number of attempts required to successfully insert the NGT
Time Frame: 1 year
The number of attempts of successful NGT insertion
1 year
Procedural complications/adverse events.
Time Frame: 1 year
Records complications and adverse effects
1 year
FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion.
Time Frame: up to 180 minutes
Scores from 0 to 10. Higher scores mean worse outcome
up to 180 minutes
Length of stay in ED
Time Frame: up to 180 minutes
Length of stay in minutes
up to 180 minutes
Duration of NGT feed.
Time Frame: up to 180 minutes
The observer records data on chart
up to 180 minutes
Tolerated volume of NGT feed.
Time Frame: 1 year
Amount of fluid (ml)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Fatihi Toaimah, MD, PhD, Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-19-442

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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