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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01075789

Acronym

NGTIPPS

Enrollment

Registered

2010-02-25

Start date

2010-05-31

Completion date

2011-03-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult

Keywords

Pain, Discomfort, Insertion, Nasogastric tube

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.

Interventions

DRUGLignocaine

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Reduction in mean visual analogue scores (VAS) in study arm	10 minutes following nasogastric tube intubation

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026