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

Intubation; Difficult Clinical Trial

— NGTIPPS  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01075789
• Other study ID #: NGTIPPS
• Status: Terminated
• Phase: N/A
• First received: February 24, 2010
• Last updated: March 30, 2016
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2016
• Source: Queensland Children's Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Drug:
• Lignocaine
Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.
• Placebo
Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.

Locations

Country	Name	City	State
Australia	Queensland Children's Medical Research Institute	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Queensland Children's Medical Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in mean visual analogue scores (VAS) in study arm		10 minutes following nasogastric tube intubation	No