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Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children

NCT04571879 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-03-02

No results posted yet for this study

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.

Conditions

  • Procedural Anxiety
  • Procedural Pain

Interventions

DRUG

Nebulized Lidocaine

Nebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children

DRUG

Intranasal Midazolam

Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion

OTHER

Placebo

Nebulized normal saline and intranasal normal sline

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Fatihi Toaimah, MD, PhD · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2023-12-30
Completion
2024-02-28

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571879 on ClinicalTrials.gov