Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Open-label, prospective study to assess the safety, tolerability, analgesic effect and feasibility of IN SUF/KET in pediatric patients with moderate or severe pain, in an acute care setting

This research is testing a new type of pain medicine, given as a nasal spray, for children and young people experiencing moderate to severe pain. This pain might be from an injury or illness that has brought them to the hospital. The main goal is to find out how effective this nasal spray is at reducing pain. We'll also check if it's safe to use and if children find it acceptable. We'll measure changes in pain levels using special scales designed for different ages. This study is in an early stage (Phase II), meaning we're exploring its potential to be a helpful pain relief option for young patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cessatech A/S

Enrolment target

Start

09 Oct 2023

Pain

What is this study about?

When children are in hospital with pain, it's really important to give them relief quickly and safely. This study is looking at a new medicine that's given as a nasal spray. The medicine is called sufentanil and ketamine (IN SUF/KET), and the idea is that a nasal spray might be easier and quicker to give than injections or medicines that need to be swallowed, especially when a child is in a lot of pain. We want to see if this new approach can help children feel better more quickly.

This study is for children and young people who are in hospital and are experiencing pain that is moderate to severe. 'Moderate to severe' means the pain is strong enough to be very uncomfortable and needs medicine to help. We'll be carefully watching how much their pain changes after they get the nasal spray.

We'll use different ways to measure pain depending on the child's age. For very young children (aged 1 to under 5), we'll use a special scale called FLACC, which looks at things like their facial expressions and body movements. For children aged 5 to under 9, we'll use the Wong-Baker faces scale, where they choose a face that shows how much pain they feel. For children aged 9 and older, we'll use a simple 0-10 scale where 0 means no pain and 10 means the worst pain imaginable. The study also wants to check how long the pain relief lasts and if children need other pain medicines as well.

Key takeaways

New nasal spray for children's pain.
Aimed at moderate to severe pain in hospital.
Goal is to see how well it works and if it's safe and easy to use.
Pain measured differently depending on child's age.
Participants are monitored closely for about an hour after dose.
Children aged 1 to 18 years are eligible.

Who may be eligible?

This study is for children and young people of all genders who are in hospital and are experiencing moderate to severe pain. This means their pain is causing them significant discomfort.

To join, a child needs to be between 1 year old and 18 years old. The healthcare team will check other specific medical conditions to make sure the study medicine is safe for them.

It's important that children (where appropriate for their age) and their parents or guardians understand what the study involves and agree to take part.

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 currently in hospital with pain?
Is my child experiencing moderate to severe pain?
Is my child between 1 and 18 years old?
Am I, as a parent or guardian, willing to give my permission?
Does my child seem well enough to participate in the assessments?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive the study nasal spray when they are experiencing moderate to severe pain in the hospital. Before and after receiving the spray, the medical team will ask them about their pain levels using the age-appropriate pain scales mentioned earlier (like the FLACC scale, Wong-Baker faces, or a 0-10 rating).

These pain assessments will happen at specific times, such as before the spray, and then at 10, 15, 20, 30, 45, and 60 minutes after taking it. The healthcare team will also keep track of any other pain medicines your child might need during this time. The total duration of your child's active participation in the study will be focused on the period shortly after receiving the nasal spray, typically around an hour, to see how well it works and if there are any immediate side effects.

Potential risks and benefits

Taking part in this study could potentially offer faster and more effective pain relief through a new, easier-to-give medicine. However, like all medicines, the nasal spray might have side effects, and some people might not respond to it as well as others. The doctors and nurses will carefully monitor your child throughout the study for any reactions or changes. 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)

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

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Unverified
Spain

Common questions

What kind of pain is this study for?

This study is for children in hospital with moderate to severe pain, which means pain that is quite strong and needs medicine to help.

How will the medicine be given?

The medicine will be given as a nasal spray into your child's nose.

How will my child's pain be measured?

We use different methods depending on your child's age: observation for toddlers, special 'faces' for younger children, and a 0-10 number scale for older children.

How long will my child be involved in the study each time they get the medicine?

For each time your child receives the medicine, we will monitor them for up to an hour to measure pain relief and any effects.

Can my child get other pain relief if this medicine doesn't work?

Yes, if the study medicine doesn't relieve their pain enough, they can still receive other pain medicines as needed.