Clinical trial NCT01075789: Using Lignocaine Spray and Gel to Reduce the Pain Associated With Nasogastric Tube Insertion in Children
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intubation; Difficult
Keywords: Pain
Discomfort
Insertion
Nasogastric tube
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in mean visual analogue scores (VAS) in study arm
timeFrame: 10 minutes following nasogastric tube intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Queensland Children's Medical Research Institute
state: Queensland
Study officials:
affiliation: Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory
name: Nicholas T O Neill, BN
role: PRINCIPAL_INVESTIGATOR
References: