AuthorisedPhase III and phase IV (Integrated)Interventional

“Study of pain syndrome and clinical-biochemical parameters in children aged 7 to 18 years in cases of non-surgical treatment of uncomplicated acute appendicitis”

This research study is looking into a pain medicine called Ketorolac for children and teenagers between 7 and 18 years old. The children in this study have a common condition called appendicitis, but it's a version that doesn't need an operation. The main goal is to see how well Ketorolac helps with pain and how it affects some natural processes in the body over a 3-day period. This information will help doctors understand the best ways to manage pain for young people with this kind of appendicitis.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Riga Stradins University

Enrolment target

120

Start

30 Jan 2025

uncomplicated acute appendicitis

What is this study about?

This research study, called a clinical trial, is focusing on children and teenagers who have a condition called acute appendicitis. Acute appendicitis is when your appendix, a small finger-shaped pouch connected to your large intestine, becomes swollen and painful. Often, this means you need an operation to remove it. However, sometimes the appendicitis is not severe and doctors might decide to treat it with medicine instead of surgery.

In this particular study, scientists are looking at how a specific pain medication, called Ketorolac, works in these young patients (aged 7 to 18) whose appendicitis doesn't require surgery. The study wants to understand exactly how well Ketorolac helps with pain relief and also observe how it might affect certain natural measures within the body. This is a very common type of study as it aims to improve how we care for children experiencing pain.

By carefully observing how patients respond to Ketorolac, the researchers hope to gather important information. This information could help doctors make better decisions about managing pain and treatment for young people with uncomplicated appendicitis in the future, potentially reducing the need for surgery in some cases and improving their comfort.

Key takeaways

The study explores a pain medicine for children (7-18) with mild appendicitis.
It aims to find better ways to manage pain without surgery.
Participation involves receiving injections and having pain and body measures checked for 3 days.
It's for appendicitis that doctors believe can be treated with medicine.
The findings could improve future care for young people with this condition.

Who may be eligible?

This study is for children and teenagers from 7 to 18 years old. It includes both boys and girls.

The main requirement for joining this study is that you must have been diagnosed with acute appendicitis that is considered 'uncomplicated.' This means your doctors believe it doesn't need an operation right away and can be treated with medicine.

More specific details about who can and cannot join will be discussed with you and your parents by the study team or your doctor. They will carefully check your medical history to make sure the study is safe and suitable for you.

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.

Am I between 7 and 18 years old?
Have doctors told me I have acute appendicitis that is not severe?
Have doctors said my appendicitis might not need an operation?
Am I able to visit the clinic for checks over three days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will first explain everything very carefully. You and your parents will need to agree to participate.

Then, you will receive the study medication, Ketorolac, as an injection. Over a period of three days (72 hours), the study team will regularly check your pain levels. They will also take some samples, like blood tests, to look at specific body measures. You will have assessments at different times during these three days to see how the medication is working and how you are feeling. The entire study participation period involves these checks and treatments over the three-day monitoring period.

Potential risks and benefits

Taking part in any study has possible benefits and risks. A potential benefit of this study is that the treatment you receive might help manage your appendicitis pain effectively. The information gathered from your participation will also help others in the future by improving understanding of how to treat uncomplicated appendicitis in children. Potential risks could include side effects from the medication, such as mild discomfort at the injection site or other effects, which the study team will explain fully. You will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Latvia

Common questions

What is 'uncomplicated acute appendicitis'?

It means your appendix is inflamed, but your doctors believe it's not severe enough to need surgery and can be treated with medication.

What is Ketorolac?

Ketorolac is a medicine used to relieve pain. In this study, it's given as an injection.

How long will I be in the study?

The main part of the study involves monitoring your pain and treatment over three days (72 hours).

Will I still get my usual care if I join?

Yes, joining the study will not affect your standard medical care, and your doctors will continue to look after you.

Will I have to have an operation?

This study is specifically for appendicitis that does NOT need an operation, but your doctors will always monitor your condition carefully.