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

NCT ID: NCT01075789

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-03-31

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.

Conditions

Intubation; Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Lignocaine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Lignocaine

Intervention Type: DRUG

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

Interventions

Lignocaine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Dr Stephen Lambert

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas T O Neill, BN

Role: PRINCIPAL_INVESTIGATOR

Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory

Locations

Queensland Children's Medical Research Institute

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

NGTIPPS

Identifier Type: -

Identifier Source: org_study_id