Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA
This study is for children aged 2-18 with sickle cell disease. We're investigating if a pain and calming gas called MEOPA (nitrous oxide) used during hospital stays affects their vitamin B12 levels. When vitamin B12 is affected, it can cause problems with the body, like nerve issues. We want to see how much MEOPA might cause this and if some children are more at risk. We'll collect blood and urine samples during their hospital stay for a pain crisis, and check on them after they go home to see if any new problems develop related to B12. This will help doctors better understand how to use MEOPA safely.
At a glance
What is this study about?
Sickle cell disease is a condition where red blood cells are shaped differently, like a sickle. This can cause them to block small blood vessels, leading to painful events called crisis. When children with sickle cell disease are in hospital for these painful crises, doctors often use a special gas called MEOPA to help with pain and make them feel more relaxed. MEOPA contains a gas called nitrous oxide.
Scientists have found that nitrous oxide can stop vitamin B12 from working properly in the body. Vitamin B12 is really important for many things, including healthy nerves and making DNA. If your body doesn't have enough working B12, it can lead to various problems, from feeling dizzy when standing up to more serious nerve issues. We already know that the more MEOPA someone gets, the bigger the impact on their B12, but we don't know exactly how much is too much, or if some children with sickle cell disease are more likely to be affected.
This study aims to get a clearer picture of this. We want to understand if using MEOPA during a sickle cell crisis truly causes B12 levels to drop and if this leads to any noticeable health changes. By studying children during their hospital stay and for a short time after, we hope to learn how to best care for children with sickle cell disease who use MEOPA.
Key takeaways
- The study looks at how MEOPA gas affects vitamin B12 in children with sickle cell disease.
- B12 is important for healthy nerves and other body functions.
- Participation involves extra blood tests during a hospital stay and two follow-up checks.
- The goal is to learn how to use MEOPA more safely for children with sickle cell disease.
- There are minimal risks, mainly from blood collection.
- You can withdraw from the study at any time without affecting your child's care.
Who may be eligible?
This study is specifically looking for children who have sickle cell disease. They need to be between 2 and 18 years old. Also, for healthcare reasons, participants need to be covered by the UK's social security system, which most people in the UK are.
Children cannot join the study if they already have nerve problems before the study starts, as this would make it hard to tell if any new problems were caused by MEOPA. Additionally, if a child or their parents don't want to provide blood or other information for the study, they shouldn't take part. It's important that everyone involved feels comfortable with the study procedures.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child between 2 and 18 years old?
- Does your child have sickle cell disease?
- Does your child currently have full access to UK healthcare (social security)?
- Does your child NOT currently have any existing nerve problems?
- Are you and your child comfortable with extra blood and urine tests?
What does participation involve?
If you decide to take part, when your child is in hospital because of a sickle cell pain crisis (either after visiting the emergency room or directly in intensive care), we'll ask to collect some blood. This will be a small amount, about one teaspoon, taken at the same time as their usual blood tests. We'll use this blood to check their vitamin B12 and other related vitamins. We'll also ask for a small urine sample.
These same samples will be taken again on the day your child leaves the hospital. During their hospital stay, we will carefully keep track of how their pain is managed, do a quick check of their nerves each day, and record how much MEOPA they receive. After going home, two follow-up appointments will be scheduled: one about a week later and another about a month after leaving the hospital. These appointments are to check for any new nerve-related issues. Each child can only take part in this study once.
Potential risks and benefits
Locations (1)
- Chu ReimsVerified postcodeReims, France· Recruiting
Common questions
What is MEOPA?
MEOPA is a special gas used in hospitals to help with pain and to make patients feel calmer, often during medical procedures.
Why is vitamin B12 important?
Vitamin B12 is vital for making healthy nerves and for creating new DNA in your body. Not having enough can cause a range of health issues.
Will my child get special treatment if they join?
No, your child will receive the same medical care for their sickle cell crisis as they normally would. The study just adds some extra monitoring and tests.
How long will the study last for my child?
Mostly, it involves their hospital stay for a crisis, plus two follow-up appointments at one week and one month after they leave hospital.
Can we stop participating at any time?
Yes, absolutely. You can withdraw your child from the study at any point, and it won't affect their medical care.
How to find out more
Claire PLUCHART, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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