RecruitingPHASE3INTERVENTIONAL

Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

This study is looking at the best way to help children aged 6-17 who come to the emergency room with severe belly pain, often from suspected appendicitis. Doctors usually give an opioid called morphine for this pain, but it can have side effects. Another medicine, ketorolac, is a non-opioid that can also help with pain and inflammation, and might have fewer risks. We want to find out if ketorolac is just as good as morphine at easing pain in children, but with fewer negative effects. To do this, some children will receive ketorolac and others will receive morphine, given through a needle in the arm. This is a big study across many hospitals, and neither the child, their family, nor the doctors will know which medicine was given to ensure fair results. The aim is to find safer pain relief options for kids.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Calgary

Enrolment target

495

Start

27 May 2024

Estimated completion

01 Dec 2029

Acute Pain Abdomen, Acute Abdominal Pain Appendicitis Emergencies Child, Only

What is this study about?

When children between 6 and 17 years old have very bad belly pain, especially if it might be appendicitis, they often need strong pain relief quickly. Appendicitis is a common reason for children to need emergency surgery in Canada, and it can cause a lot of discomfort. Traditionally, a medicine called morphine, which is an opioid, has been used. While morphine is good at reducing pain, it can come with certain risks and side effects.

Because of past concerns about opioid use, doctors are now looking for other effective ways to manage pain that might be safer. One such option is ketorolac, a different kind of pain medicine that also helps with inflammation. It's thought to have fewer side effects, especially when used for a short time. The main goal of this study is to compare ketorolac and morphine. We want to see if ketorolac can ease a child's belly pain just as well as morphine, but with fewer problems.

This study will involve many hospitals across Canada and a large number of children to get clear answers. If your child takes part, they will receive either ketorolac or morphine through a drip in their arm. It's like flipping a coin to decide which one they get. To make sure the results are fair and unbiased, nobody involved in the child's care, including the child, their family, and the doctors, will know which medicine was given. Only the pharmacist who prepares it will know. This helps us objectively understand how well each medicine works and if there are any differences in side effects.

Key takeaways

Compares ketorolac (non-opioid) vs. morphine (opioid) for belly pain in children.
Aims to find out if ketorolac works as well as morphine with fewer side effects.
Children aged 6-17 with suspected appendicitis are eligible.
Medicine is given once through an IV drip; neither you nor doctors will know which one.
Pain levels and side effects will be monitored during the emergency visit.
Participation helps find safer pain relief for children in the future.

Who may be eligible?

This study is looking for children aged 6 to 17 years old who have had belly pain for five days or less, and who doctors suspect might have appendicitis. They need to be experiencing at least moderate to severe pain when they arrive at the emergency department and have a drip (IV cannula) in place or ready to be put in. Importantly, the child and their parent or guardian must be able to understand the study information and answer questions.

There are also some reasons why a child might not be able to join. For example, if they've recently taken certain pain medicines (NSAIDs or opioids), or if they have other serious health problems like very unstable blood pressure, severe kidney or liver disease, certain bleeding disorders, or inflammatory bowel disease. Children who are pregnant or breastfeeding, or who have known allergies to the study medicines, also cannot participate.

To ensure fair results, a child cannot join if they have chronic pain that requires daily pain medication or if they have previously taken part in this specific study.

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 my child between 6 and 17 years old?
Has my child had belly pain for 5 days or less?
Does my child currently have moderate to severe belly pain?
Does my child have a drip (IV) in their arm or is one being put in?
Does my child have any serious or chronic health problems (like severe kidney/liver issues, bleeding problems)?
Is my child pregnant, breastfeeding, or allergic to common pain medicines?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will have a single dose of either ketorolac or morphine given through a drip that’s already in their arm. This is a one-time treatment during their emergency department visit. To make sure the results are fair, neither you, your child, nor the doctors will know which medicine was given; this is called a 'blinded' study.

Nurses will regularly check your child's pain level and ask questions about how they are feeling over the next few hours while they are still in the emergency department. These checks might happen at 30, 60, 90, and 120 minutes after the medicine is given, and then again 6-8 hours later. This helps the study team understand how well the medicine is working and if there are any side effects. There are no extra hospital visits required beyond the usual emergency department care for your child, and the total duration of active participation is just during their emergency admission.

Potential risks and benefits

Taking part in this study could potentially benefit your child by helping to ease their pain. We also hope to learn more about which pain medicines work best and safest for children, which could help many children in the future. As with any medicine, there are potential risks, such as side effects from either ketorolac or morphine. These will be carefully monitored by the medical team. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Alberta Children's Hospital Emergency Department
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is ketorolac?

Ketorolac is a non-opioid pain medicine that helps to reduce pain and inflammation.

What is morphine?

Morphine is a strong opioid pain medicine commonly used to treat severe pain.

Why don't we know which medicine is given?

This is to make sure the results are fair and unbiased. If people don't know which medicine was given, it helps prevent opinions from affecting how the results are collected.

Will my child still get treatment if we don't join the study?

Yes, your child will receive the best medical care and pain relief available, regardless of whether you choose to participate in the study.

Are there any extra tests for this study?

No, there are no extra tests or appointments specifically for this study beyond what your child would normally have during their emergency visit.

How to find out more

Mohamed M Eltorki, MBChB, MSc

mmeltork@ucalgary.ca +1403-955-7723 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.