DEXmedetomidine Trial of Adjunct Treatment with Morphine (DEXTA)

Research summary

Aim To find if dexmedetomidine (a painkiller) can help reduce the amount of morphine needed for pain relief in babies who are on a ventilator (a machine which helps babies to breathe). Background Babies born before 37 weeks of pregnancy are premature,but those born before 32 weeks are the most likely to develop problems because of their prematurity. They often need help to breathe which may be given by a ventilator. This can be painful,so doctors give babies painkillers like morphine. Some studies have shown that morphine,in preterm babies: - is not a very effective painkiller - can make it harder to come off the ventilator as it slows the baby's own breathing - can slow bowel movements and delay feeding - extend time in intensive care - can have a harmful impact on brain development and behaviour in later childhood A new painkiller,called dexmedetomidine (dexmed),is used in adults and children. It has been used in babies,by some doctors,and the current evidence suggests it could - give pain relief - have fewer side effects and be better for brain development - when given with morphine,decrease the morphine needed to get the same pain relief To understand how dexmed can help babies,high-quality research study is needed. In this study,we will compare using dexmed with morphine against using only morphine. This will tell us if using the two together gives the same level of pain relief with less morphine. Dexmed can sometimes lower blood pressure. We will test two different doses to see which one is better at reducing the need for morphine with lesser effect on blood pressure. Design and Methods We will conduct a clinical trial where some babies on a ventilator will be given one of two doses of dexmed and morphine and some will be given morphine only. Parents will be given information and babies will only be entered into the study if their parents give written consent. We will: - Measure pain and reduce the morphine if the baby is pain free - Measure if babies who also had dexmed needed less morphine compared to those who had morphine only - Test babies' blood to check how their body handles the medicines,to work out the safest dose - Look at whether dexmed helped babies come off the ventilator sooner,feed more quickly,had a less damaging effect on the brain and better development when they are 2 years old To make sure that the comparisons are fair,whether a baby gets morphine only,or morphine with one of the two doses of dexmed,will be decided randomly using a computer programme. We will give an additional dummy medicine (placebo) to babies who receive morphine only so that those caring for the babies and collecting information will not know which baby got which medicine. All babies will have pain assessments done regularly. Patient and public involvement Parents have helped us design this study,particularly in thinking about how to explain the study to parents and outcomes that are important to them. A parent advisory group will be set up to help us throughout the study,including when and how to approach parents about participating,reviewing materials for parents,key decision making and sharing the study results. We are also working with Bliss,the UK's leading charity for parents of premature or sick babies. Dissemination Results will be shared via scientific journals and neonatal conferences. Parents and Bliss will help us to share findings with parents,including summaries,website material and social media.

Principal Investigator

Dr Eleri Adams

Contact us

Email: neonatal.research@ouh.nhs.uk

IRAS number

1012134