Nasogastric Tube Insertion Study – a randomised controlled trial

Project status: Active

Research area: Clinical Sciences > Emergency Research

This is a randomised controlled trial (RCT) of interventions to reduce the pain and distress of nasogastric tube (NG) insertion in young children.

The challenge

Nasogastric (NG) tube insertion is a common procedure in young children and is undertaken for hydration, nutritional support, gastric decompression, and medication delivery.

Despite being frequently performed, NG tube insertion is consistently associated with substantial pain and distress in infants and young children. Current approaches to procedural analgesia are inconsistent and often inadequate.

Existing paediatric evidence regarding effective pain relieving or sedative interventions for this procedure is limited. Adult data support the benefit of local anaesthetic (numbing medicine), and procedural sedation is widely used in paediatric practice for similarly distressing procedures. However, no comparative trials have evaluated commonly used sedation and pain-relieving strategies for NG tube insertion in young children.

About this study

The aim of this study is to determine the most effective method for reducing distress during NG tube insertion in children aged six months to less than five years.

Outcomes

The primary outcome is the proportion of children who experience severe distress during the first NG tube insertion attempt. Severe distress will be measured using a pain score.

Secondary outcomes include distress and sedation measured at multiple time points, procedural success and number of insertion attempts, requirements for physical restraint of children, complications, clinician‑ and caregiver‑reported outcomes, time‑based process measures, and cost‑effectiveness.

Study design

This study is a multi‑centre, open‑label randomised controlled trial to determine the most effective method to reduce distress during NG tube insertion in children aged six months to less than five years.

Participants will be randomised to one of four study arms:

Topical intranasal lidocaine – a local numbing medicine- with usual care
Intranasal midazolam – a sedative medicine - plus topical intranasal lidocaine with usual care
Intranasal fentanyl – a pain-relieving medication - plus topical intranasal lidocaine with usual care
Usual care alone.

Our research team

Professor Simon Craig, Research Lead
Associate Professor Di Crellin, Investigator at The Royal Children’s Hospital (RCH)
Jessica Nooney, Study Coordinator, Monash University