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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Reduction in mean visual analogue scores (VAS) in study arm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from parent of guardian
- •Signed assent from subject
- •Subject must have insertion of a nasogastric tube ordered as part of his/her current treatment
- •Must be 6 years of age or older
- •Must be able to complete visual analogue scale (VAS)
排除标准
- •Congenital abnormalities of the naso/oropharyngeal area
- •Any surgical alterations in the naso/oropharyngeal area
- •Known history of hypersensitivity to xylocaine or other local anaesthetics
- •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
- •Allergy to food colouring
- •Presence of tracheotomy / tracheostomy
- •Presence of tumour in the nasopharyngeal/oropharyngeal area
- •Impaired gag reflex
- •Impaired swallow
- •Any cardiac condition
- •Hypertension
- •Current use of antidepressant medication
- •Current use of cimetidine or propranolol
- •Significantly impaired liver function
- •Significantly impaired renal function
- •Current use of anti-arrhythmic medication
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Lignocaine (Drug)
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.
干预措施: Lignocaine (Drug)
结局指标
主要结局
Reduction in mean visual analogue scores (VAS) in study arm
时间窗: 10 minutes following nasogastric tube intubation
次要结局
未报告次要终点
研究者
Dr Stephen Lambert
Senior Research Fellow
The University of Queensland