None listed
Conditions
Brief summary
Nasogastric tubes are often used in children to give them fluids or medications or to drain their stomach. This involves the insertion of a narrow tube into their nostril and then down into their stomach. We know that this is a very safe and effective way of managing a number of problems in children. However, we also know that this is a painful procedure and we are looking for a way to relieve this pain. Lignocaine is commonly used in children to provide local anaesthetic before painful procedures. It is given in many ways, as an injection, applied to the mouth as a gel and sprayed in the mouth and nose, but it has not been licensed for administration by a nebuliser. Administering a medication in this way means that it is given through a mask so that it can be breathed in. The use of lignocaine in the manner proposed in this study is experimental. However, lignocaine has been administered by a nebuliser to children having different procedures and shown to be safe. It has also been given to adults by nebuliser before the insertion of a nasogastric tube and was shown to make this less painful. We will be asking families for consent for their child to participate in this study to find out whether administering nebulised lignocaine before inserting a nasogastric tube reduces the pain that the child feels. We aim to include 52 children in this study. Half of the children (26) will get the study drug (nebulised lignocaine) while the other half will get a placebo (nebulised salt water).
Interventions
The trial solution (comprising aqueous 2% Lignocaine at 4mg/kg dose in total 5mls trial solution in the experimental group versus 5mls normal saline in the control group) will be administered using a face mask and a compressed gas-powered jet nebuliser (Hudson Respiratory Care Inc., Temecula, CA, USA) with an oxygen flow rate of 6L/min. over a period of 10 minutes. This will occur 10 minutes before nasogastric intubation. Nasogastric tube insertion will proceed in a standard protocolised manner
The trial solution (comprising aqueous 2% Lignocaine at 4mg/kg dose in total 5mls trial solution in the experimental group versus 5mls normal saline in the control group) will be administered using a face mask and a compressed gas-powered jet nebuliser (Hudson Respiratory Care Inc., Temecula, CA, USA) with an oxygen flow rate of 6L/min. over a period of 10 minutes. This will occur 10 minutes before nasogastric intubation. Nasogastric tube insertion will proceed in a standard protocolised manner for all patients. The study will last for one year or until 52 patients have been successfully recruited.
Sponsors
Royal Children's Hospital (Emergency Department)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Children presenting to our Emergency Department with a clinical indication for nasogastric tube insertion.
Exclusion criteria
1. Need for immediate nasogastric tube insertion (e.g. acute gastric dilatation). 2. Non-English speaking parent/guardian - only when appropriate interpreter services cannot be accessed expeditiously (i.e. where nasogastric tube insertion is delayed by more than one hour). 3. Allergy to Lignocaine or local anaesthetic. 4. Significant co-morbid disease (asthma/chronic renal or hepatic impairment/epilepsy/cardiac disease/cognitive impairment or neurological disease).
Outcome results
None listed