DEXTA
Research type
Research Study
Full title
DEXmedetomidine Trial of Adjunct Treatment with Morphine
IRAS ID
1012134
Contact name
Shalini Ojha
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
ISRCTN Number
ISRCTN24287322
Research summary
Premature babies born before 32 weeks are the most likely to develop problems due to prematurity. They often need help to breathe which may be given by a ventilator (a machine which helps breathing). This can be painful, so doctors give painkillers like morphine.
Some studies have shown that morphine is not very effective in preterm babies, can make it harder to come off the ventilator and has a harmful impact on brain development and behaviour in childhood. A new painkiller, called dexmedetomidine (dexmed), is used in adults and children. It has been used in some babies and the evidence suggests it could give pain relief with fewer side effects and be better for brain development. When given with morphine, it may decrease the morphine needed to get the same pain relief.
In this study, in babies who are on a ventilator, we will compare using dexmed with morphine against using only morphine to find out if babies who also have dexmed need less morphine. Dexmed can sometimes lower heart rate and blood pressure. We will also see which dose has lesser effect on these.
We will give some babies one of two doses of dexmed and morphine and some morphine only. Parents will be given information and babies will only participate with their written consent.
We will measure:
• pain and reduce the medicines if the baby is pain free
• if babies who also had dexmed needed less morphine compared to those who had morphine only
• babies’ blood to check how their body handles the medicines
• coming off the ventilator sooner and development at 2 years old
To make a fair comparison, treatment will be decided randomly. We will give a dummy medicine (placebo) to babies who receive morphine only so carers will not know which baby got which medicine.
Parents have helped us design this study, and a parent advisory group will help us throughout the study and to share the results. We are working with Bliss, the UK’s leading charity for parents of premature babies.REC name
HSC REC B
REC reference
25/NI/0113
Date of REC Opinion
6 Oct 2025
REC opinion
Further Information Favourable Opinion