Randomised, double-blind, placebo-controlled, active-treatment clinical trial to assess the analgesic efficacy and safety of an oral combination of ibuprofen (arginine) -tramadol HCl administered to patients with moderate to severe pain after undergoing dental surgery.
This research study is investigating a new pain relief option for people experiencing moderate to severe pain after dental surgery. It's a 'Phase III' clinical trial, meaning it's a final big step before a new medicine might be approved. The researchers want to find out if a combination of two common pain medicines, ibuprofen (a type of anti-inflammatory) and tramadol (a stronger painkiller), works better and more safely than either drug alone or a placebo (a dummy pill with no medicine). They will carefully measure how much pain people have and for how long, as well as checking for any side effects. The aim is to provide more effective pain management for patients after dental procedures.
At a glance
What is this study about?
Imagine you've just had dental surgery and are experiencing a fair amount of pain – not just a little ache, but something that really makes you uncomfortable. This study is all about trying to find a better way to help people like you manage that kind of pain. Researchers are testing a new pain medication that combines two well-known drugs: ibuprofen, which helps with swelling and pain, and tramadol, a stronger painkiller. They want to see if putting them together works more effectively than using just one of them, or a sugar pill (a 'placebo').
This is a 'Phase III' trial, which means it's one of the last and most important stages of testing a new medicine. It involves a larger group of people to confirm whether the new treatment is both effective and safe. The goal is to see if this combination medication can significantly reduce pain after dental surgery, how quickly it starts working, and how long the pain relief lasts. They will be comparing it not only to a placebo but also to other standard pain treatments.
The main thing researchers will measure is how much your pain changes during the first 12 hours after taking the medication. They'll use a special scale where you rate your pain. They'll also look at things like how quickly you feel better, if you need extra painkillers, and if there are any side effects. This careful process helps ensure that any new medicine is thoroughly tested before it can become available to the public, aiming to improve pain relief options for patients.
Key takeaways
- This study aims to find a more effective pain relief for dental surgery.
- It tests a new combination of ibuprofen and tramadol against current treatments and a dummy pill.
- You will be closely monitored for pain relief and any side effects.
- Both men and women, aged 18 and over, with moderate to severe dental pain may be eligible.
- Your participation could help improve pain management for future patients.
Who may be eligible?
This study is looking for volunteers who are at least 18 years old. Both men and women can take part.
To be considered for this study, you must be experiencing moderate to severe pain specifically after having dental surgery. The researchers need to confirm that your pain level fits what they are studying.
There might be other health conditions or medications that would prevent someone from joining, as the researchers need to ensure the study is safe and the results are clear. Your doctor or the study team will go through all the detailed requirements with you.
- Are you 18 years old or older?
- Are you experiencing pain after dental surgery?
- Is your pain considered moderate to severe?
- Are you able to follow study instructions and attend appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be given one of the study medications – it could be the new combination painkiller, a standard painkiller, or a dummy pill (placebo). You won't know which one you're getting, and neither will your study doctor, to make sure the results are fair. The medication will either be granules you mix into a drink or an oral solution you take by mouth.
You'll be asked to regularly rate your pain using a special scale, especially important during the first 12 hours, and then for up to 48 hours. You'll also be monitored for any side effects and researchers will keep track of whether you need any additional pain relief. You'll likely have your vital signs (like heart rate and blood pressure) checked and may have some general physical exams and blood tests. The exact number of visits and the total duration aren't specified but typically trials like this involve a period of active monitoring after taking the medication, followed by a final check-up.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What kind of pain is this study for?
This study is for people experiencing moderate to severe pain after dental surgery.
What kind of medicine will I take?
You'll take either a new combination painkiller, a standard painkiller, or a dummy pill. It will be in the form of granules to mix or an oral solution.
Will I know which medicine I am taking?
No, neither you nor your study doctor will know which medication you are receiving. This is to ensure the study results are unbiased.
How long will I be monitored for pain?
Your pain will be carefully measured, especially during the first 12 hours after taking the medicine, and then for up to 48 hours.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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