NCT04571879

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2021

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 2, 2023

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

September 10, 2020

Last Update Submit

March 1, 2023

Conditions

Procedural AnxietyProcedural Pain

Outcome Measures

Primary Outcomes (1)

  • Pain severity rating scale (FLACC) during insertion of NGT.

    score from 0 to 10. Higher scores mean worse outcome

    1 year

Secondary Outcomes (8)

  • Observer/caregiver pain severity rating:

    1 year

  • The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion.

    1 year

  • The number of attempts required to successfully insert the NGT

    1 year

  • Procedural complications/adverse events.

    1 year

  • FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion.

    up to 180 minutes

  • +3 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL

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 LidocaineDrug: Intranasal Midazolam

Arm 2

EXPERIMENTAL

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

Arm 3

PLACEBO COMPARATOR

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

Interventions

Nebulized LidocaineDRUG

Nebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children

Also known as: Nebulized Xylocaine
Arm 1
Intranasal MidazolamDRUG

Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion

Also known as: IN Midazolam
Arm 1Arm 2
PlaceboOTHER

Nebulized normal saline and intranasal normal sline

Arm 3

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Indication for an urgent insertion of a nasogastric tube.
  • Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pediatric Emergency Center, Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

Sidra Medicine

Doha, 3050, Qatar

NOT YET RECRUITING

Related Publications (14)

  • Shih S, Rosen P. Pain Management for Nasogastric Intubation in Pediatrics. Cureus. 2018 Oct 9;10(10):e3429. doi: 10.7759/cureus.3429.

    PMID: 30555754RESULT

  • Tapaiwala SN, Al Riyami D, Cole E. A painful and knotted nasogastric tube. CMAJ. 2008 Feb 26;178(5):568. doi: 10.1503/cmaj.070750. No abstract available.

    PMID: 18299545RESULT

  • Ruda MA, Ling QD, Hohmann AG, Peng YB, Tachibana T. Altered nociceptive neuronal circuits after neonatal peripheral inflammation. Science. 2000 Jul 28;289(5479):628-31. doi: 10.1126/science.289.5479.628.

    PMID: 10915627RESULT

  • Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.

    PMID: 16330518RESULT

  • Brewer S, Gleditsch SL, Syblik D, Tietjens ME, Vacik HW. Pediatric anxiety: child life intervention in day surgery. J Pediatr Nurs. 2006 Feb;21(1):13-22. doi: 10.1016/j.pedn.2005.06.004.

    PMID: 16428010RESULT

  • Gjonaj ST, Lowenthal DB, Dozor AJ. Nebulized lidocaine administered to infants and children undergoing flexible bronchoscopy. Chest. 1997 Dec;112(6):1665-9. doi: 10.1378/chest.112.6.1665.

    PMID: 9404766RESULT

  • Babl FE, Goldfinch C, Mandrawa C, Crellin D, O'Sullivan R, Donath S. Does nebulized lidocaine reduce the pain and distress of nasogastric tube insertion in young children? A randomized, double-blind, placebo-controlled trial. Pediatrics. 2009 Jun;123(6):1548-55. doi: 10.1542/peds.2008-1897.

    PMID: 19482767RESULT

  • Craig SS, Seith RW, Cheek JA, Wilson K, Egerton-Warburton D, Paul E, West A. Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial. Lancet Child Adolesc Health. 2019 Jun;3(6):391-397. doi: 10.1016/S2352-4642(19)30058-6. Epub 2019 Apr 15.

    PMID: 31000379RESULT

  • Cullen L, Taylor D, Taylor S, Chu K. Nebulized lidocaine decreases the discomfort of nasogastric tube insertion: a randomized, double-blind trial. Ann Emerg Med. 2004 Aug;44(2):131-7. doi: 10.1016/j.annemergmed.2004.03.033.

    PMID: 15278085RESULT

  • Pacifici GM. Clinical pharmacology of midazolam in neonates and children: effect of disease-a review. Int J Pediatr. 2014;2014:309342. doi: 10.1155/2014/309342. Epub 2014 Feb 18.

    PMID: 24696691RESULT

  • Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.

    PMID: 3195771RESULT

  • Theroux MC, West DW, Corddry DH, Hyde PM, Bachrach SJ, Cronan KM, Kettrick RG. Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics. 1993 Mar;91(3):624-7.

    PMID: 8441570RESULT

  • McCormick AS, Thomas VL, Berry D, Thomas PW. Plasma concentrations and sedation scores after nebulized and intranasal midazolam in healthy volunteers. Br J Anaesth. 2008 May;100(5):631-6. doi: 10.1093/bja/aen072. Epub 2008 Apr 2.

    PMID: 18385262RESULT

  • Knoester PD, Jonker DM, Van Der Hoeven RT, Vermeij TA, Edelbroek PM, Brekelmans GJ, de Haan GJ. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers. Br J Clin Pharmacol. 2002 May;53(5):501-7. doi: 10.1046/j.1365-2125.2002.01588.x.

    PMID: 11994056RESULT

MeSH Terms

Conditions

Pain, Procedural

Interventions

Midazolam

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Fatihi Toaimah, MD, PhD

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatihi HS Toaimah, PhD

CONTACT

+97455628632ftoaimah@hamad.qa

Khalid Alansari

CONTACT

kalansari@sidra.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

October 1, 2020

Study Start

August 25, 2021

Primary Completion

December 30, 2023

Study Completion

February 28, 2024

Last Updated

March 2, 2023

Record last verified: 2022-06

Locations

QA(2)