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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Queensland Children's Medical Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Queensland Children's Medical Research Institute
ClinicalTrials.gov Identifier:
NCT01075789
First received: February 24, 2010
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Intubation; Difficult
Drug: Lignocaine
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by Queensland Children's Medical Research Institute:

Primary Outcome Measures:
  • Reduction in mean visual analogue scores (VAS) in study arm [ Time Frame: 10 minutes following nasogastric tube intubation ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.
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.
Drug: Lignocaine
Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.
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.
Drug: Lignocaine
Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075789

Contacts
Contact: Nicholas T O Neill, BN +61 7 3636 1618 n.oneill@uq.edu.au
Contact: Stephen B Lambert, MBBS +61 7 3636 1572 sblambert@uq.edu.au

Locations
Australia, Queensland
Queensland Children's Medical Research Institute Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Stephen B Lambert, MBBS    +61 7 3636 1572    sblambert@uq.edu.au   
Contact: Keith Grimwood, MD    +61 7 3636 5558    keith_grimwood@health.qld.gov.au   
Principal Investigator: Nicholas T O Neill, BN         
Sponsors and Collaborators
Queensland Children's Medical Research Institute
Investigators
Principal Investigator: Nicholas T O Neill, BN Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory
  More Information

No publications provided

Responsible Party: Nicholas O Neill CN, Queensland Paediatric Infectious Diseases Laboratory
ClinicalTrials.gov Identifier: NCT01075789     History of Changes
Other Study ID Numbers: NGTIPPS
Study First Received: February 24, 2010
Last Updated: February 23, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Queensland Children's Medical Research Institute:
Pain
Discomfort
Insertion
Nasogastric tube

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014