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

The University of Queensland

Status: Terminated

Conditions: Intubation; Difficult

Treatments: Drug: Lignocaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01075789

NGTIPPS

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Congenital abnormalities of the naso/oropharyngeal area
2. Any surgical alterations in the naso/oropharyngeal area
3. Mucositis
4. Known history of hypersensitivity to xylocaine or other local anaesthetics
5. 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
6. Allergy to food colouring
7. Presence of tracheotomy / tracheostomy
8. Presence of tumour in the nasopharyngeal/oropharyngeal area
9. Impaired gag reflex
10. Impaired swallow
11. Any cardiac condition
12. Diabetes
13. Hypertension
14. Current use of antidepressant medication
15. Current use of cimetidine or propranolol
16. Significantly impaired liver function
17. Significantly impaired renal function
18. Current use of anti-arrhythmic medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Lignocaine

Active Comparator group

Description:

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.

Treatment:

Drug: Lignocaine

Pre/post intervention evaluation group

Active Comparator group

Description:

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.

Treatment:

Drug: Lignocaine