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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01075789




Registration number
NCT01075789
Ethics application status
Date submitted
24/02/2010
Date registered
25/02/2010
Date last updated
31/03/2016

Titles & IDs
Public title
Using Lignocaine Spray and Gel to Reduce the Pain Associated With Nasogastric Tube Insertion in Children
Scientific 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.
Secondary ID [1] 0 0
NGTIPPS
Universal Trial Number (UTN)
Trial acronym
NGTIPPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation; Difficult 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lignocaine
Treatment: Drugs - Placebo

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.

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.

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.


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

Treatment: Drugs: Placebo
Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in mean visual analogue scores (VAS) in study arm
Timepoint [1] 0 0
10 minutes following nasogastric tube intubation

Eligibility
Key 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)
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Children's Medical Research Institute - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01075789
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas T O Neill, BN
Address 0 0
Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01075789