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Failure to recruit
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
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| Lignocaine | Active Comparator | 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. |
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| Pre/post intervention evaluation group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lignocaine | Drug | Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mean visual analogue scores (VAS) in study arm | 10 minutes following nasogastric tube intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas T O Neill, BN | Royal Children's Hospital, Queensland Paediatric Infectious Diseases Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queensland Children's Medical Research Institute | Brisbane | Queensland | 4029 | Australia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx. |
|
| Aniline Compounds |
| D000588 | Amines |