Using Lignocaine Spray and Gel to Reduce the Pain Associated With Nasogastric Tube Insertion in Children

NCT01075789 | Terminated

• 1 other identifier: NGTIPPS
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Nasogastric tube insertion is one of the most common invasive procedures performed in children's hospitals, and has long been recognised as one of the most traumatic and painful. As a once off procedure, a nasogastric tube insertion is extremely distressing but the repeated procedures that many children endure as a necessary part of treatment for a chronic disease can be so traumatic that psychological damage may occur. There have been a limited number of studies carried out which have looked at methods to reduce the pain and trauma associated with this procedure, but most of these have been carried out in the adult population. The investigators propose to carry out a research project in a paediatric setting to definitively investigate the use of local anaesthetic spray, in combination with local anaesthetic gel, to numb the nasal passages and the back of the throat, with the aim of reducing or removing the unpleasant sensation of the nasogastric tube placement. If the study shows a benefit from the use of local anaesthetics, it would be an inexpensive and easily incorporated intervention that could be inserted into the routine procedure for nasogastric tube insertion.

Conditions

Intubation; Difficult

Keywords

Pain; Discomfort; Insertion; Nasogastric tube

Outcome Measures

Primary Outcomes (1)

• Reduction in mean visual analogue scores (VAS) in study arm

  10 minutes following nasogastric tube intubation

Study Arms (3)

Placebo

PLACEBO COMPARATOR

This arm will include children aged 6 years of age and older seen at the Royal Children's Hospital who are having an NGT inserted for a clinical indication and who have never experienced an NGT insertion before. These children will be randomised to be in this placebo arm or the treatment arm in a 1:1 ratio. The placebo for swallowing is a viscous, coloured, sucrose-flavoured gel designed to match the appearance of the treatment lignocaine gel to be swallowed by the treatment arm, and normal saline will be delivered to the nasal turbinates and nasopharynx in a similar way to atomised xylocaine in the treatment arm.

Drug: Placebo

Lignocaine

ACTIVE COMPARATOR

This arm will include children aged 6 years of age and older seen at the Royal Children's Hospital who are having an NGT inserted for a clinical indication and who have never experienced an NGT insertion before. These children will be randomised to be in this treatment placebo arm or the treatment arm in a 1:1 ratio. The children in the treatment arm will receive xylocaine viscous 2% to swallow, and atomised 10% xylocaine to the nasal turbinates and nasopharynx.

Drug: Lignocaine

Pre/post intervention evaluation group

ACTIVE COMPARATOR

This is a contemporaneous arm of children aged 6 years of age and older requiring nasogastric intubation for a clinical reason, who have previously had a nasogastric tube inserted. These children will be ask to rate by recall their previous NGT intubation on a VAS pain scale, and then will perform a post-procedure VAS pain assessment.

Drug: Lignocaine

Interventions

Lignocaine DRUG

Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.

Lignocaine; Pre/post intervention evaluation group

Placebo DRUG

Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.

Placebo

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent from parent of guardian
• Signed assent from subject
• Subject must have insertion of a nasogastric tube ordered as part of his/her current treatment
• Must be 6 years of age or older
• Must be able to complete visual analogue scale (VAS)

You may not qualify if:

• Congenital abnormalities of the naso/oropharyngeal area
• Any surgical alterations in the naso/oropharyngeal area
• Mucositis
• Known history of hypersensitivity to xylocaine or other local anaesthetics
• Known history of hypersensitivity to other components of the xylocaine solutions such as methyl or propyl hydroxybenzoate, ethanol, polyethylene glycol 400, banana flavour PHL-131980, menthol, saccharin
• Allergy to food colouring
• Presence of tracheotomy / tracheostomy
• Presence of tumour in the nasopharyngeal/oropharyngeal area
• Impaired gag reflex
• Impaired swallow
• Any cardiac condition
• Diabetes
• Hypertension
• Current use of antidepressant medication
• Current use of cimetidine or propranolol

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

Queensland Children's Medical Research Institute

Brisbane, Queensland, 4029, Australia

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nicholas T O Neill, BN

  Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

AU (1)