RecruitingACTRN12607000156482

Does Nebulised Lignocaine Reduce Children's Pain When a Nasogastric Tube is Inserted?

Randomised Controlled Trial of Nebulised Lignocaine Versus Placebo for Relief of Pain of Nasogastric Tube Insertion in Children.


Sponsor

Royal Children's Hospital (Emergency Department)

Enrollment

52 participants

Start Date

Nov 14, 2006

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for young children who need a nasogastric tube — a thin tube inserted through the nose and down to the stomach — for medical treatment in the Emergency Department. Inserting this tube is uncomfortable, and the study tests whether breathing in a mist of the local anaesthetic lignocaine through a mask (a nebuliser) before the procedure makes it less painful. The study compares lignocaine mist to salt water mist (a placebo) in children aged 1 to 5 years. You may be eligible if: - Your child is between 1 and 5 years old - Your child needs a nasogastric tube inserted for a medical reason in the Emergency Department You may NOT be eligible if: - Your child needs the tube inserted immediately (emergency situation) - Your child has an allergy to lignocaine or other local anaesthetics - Your child has a significant medical condition such as asthma, kidney or liver disease, epilepsy, heart disease, or a cognitive or neurological impairment - An English-speaking parent or interpreter is not available in time Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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ACTRN12607000156482