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

Sponsor

The University of Queensland (Other)

Overall Status

Terminated

CT.gov ID

NCT01075789

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation; Difficult	Drug: Lignocaine Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

The Combined Use of Intranasal Lignocaine Spray and Oral Lignocaine Gel to Reduce the Pain and Trauma Associated With Nasogastric Tube Insertion in Hospitalised Children.

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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 Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.
Active Comparator: Lignocaine 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 Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.
Active Comparator: Pre/post intervention evaluation group 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 Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

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

Active Comparator: Lignocaine

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

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

Active Comparator: Pre/post intervention evaluation group

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

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

Outcome Measures

Primary Outcome Measures

Reduction in mean visual analogue scores (VAS) in study arm [10 minutes following nasogastric tube intubation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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
Significantly impaired liver function
Significantly impaired renal function
Current use of anti-arrhythmic medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queensland Children's Medical Research Institute	Brisbane	Queensland	Australia	4029

Sponsors and Collaborators

The University of Queensland

Investigators

Principal Investigator: Nicholas T O Neill, BN, Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Stephen Lambert, Senior Research Fellow, The University of Queensland

ClinicalTrials.gov Identifier:

NCT01075789

Other Study ID Numbers:

NGTIPPS

First Posted:

Feb 25, 2010

Last Update Posted:

Mar 31, 2016

Last Verified:

Mar 1, 2016

Keywords provided by Dr Stephen Lambert, Senior Research Fellow, The University of Queensland

Additional relevant MeSH terms:

Lidocaine

Study Results

No Results Posted as of Mar 31, 2016