Study on the Safety and Pain Relief of Nasal Spray with Ketamine Hydrochloride and Sufentanil Citrate for Children with Moderate to Severe Pain

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What is this study about?

This clinical trial is focused on studying the treatment of pain in children who are experiencing moderate to severe discomfort, typically after an injury. The treatment being tested is a nasal spray solution containing two active substances: ketamine hydrochloride and sufentanil citrate. These substances are known for their pain-relieving properties and are being combined in a product referred to as CT001.

The purpose of the study is to evaluate how safe and tolerable this treatment is for children, as well as how effective it is at reducing pain. Children participating in the study will receive the nasal spray, and their pain levels will be monitored over a short period. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study aims to see how quickly and effectively the treatment can reduce pain in an emergency care setting.

Throughout the study, researchers will observe changes in pain intensity at various time points after administering the treatment. This will help determine how well the nasal spray works in providing relief. The study is designed to ensure the safety of the participants while gathering valuable information about the potential benefits of this new treatment for managing pain in children.

1 joining the study

The study involves pediatric participants aged 1 to 17 years who are experiencing moderate to severe pain due to an injury and are attending an emergency department.

Consent must be obtained from a parent or guardian, and assent from the child if possible, depending on age.

2 initial assessment

Pain intensity is assessed using age-appropriate scales: the FLACC score for ages 1 to less than 5 years, the Wong-Baker FACES scale for ages 5 to less than 9 years, and the 0-10 Numerical Rating Scale (NRS) for ages 9 and above.

3 medication administration

The medication used in the study is a nasal spray solution containing ketamine hydrochloride and sufentanil citrate.

The purpose is to assess the safety, tolerability, and pain-relieving effect of the medication in an acute care setting.

4 pain assessment post-medication

Pain intensity is reassessed at various intervals: 10, 15, 20, 30, 45, and 60 minutes after the medication is given.

The primary goal is to observe changes in pain intensity from the initial assessment.

5 evaluation of pain relief

The study evaluates the maximum change in pain intensity within 30 minutes after medication administration.

The number and proportion of participants achieving a 30% reduction in pain intensity within 30 minutes are recorded.

6 additional assessments

Additional variables such as the area under the curve (AUC), peak change in pain intensity, and duration of effect are calculated from the recorded pain assessments.

The number of children receiving additional pain relief medications is also assessed at each time point.

Who Can Join the Study?

The participant must be a child or teenager between the ages of 1 and 17 years old.
The participant must be visiting an Emergency Department (ED) after getting injured.
The participant must be experiencing acute pain that is moderate to severe. This means the pain level is 5 or higher on a pain scale suitable for their age. These scales include the 0-10 NRS, Wong-Baker FACES scale, and FLACC pain scale.
The parent or guardian must give informed consent, which means they agree to the study after understanding what it involves. If the child is old enough, they should also agree to participate, which is called giving assent.

Who Cannot Join the Study?

Participants who have any allergies to the study medication or its ingredients.
Participants with a history of severe allergic reactions, which are intense and potentially life-threatening responses to substances.
Participants who are currently taking other medications that might interfere with the study medication.
Participants with any medical condition that the study doctors believe could make participation unsafe.
Participants who have participated in another clinical trial within the last 30 days.
Participants who are unable to follow the study procedures or instructions.
Participants with a history of drug or alcohol abuse, which means using substances in a harmful way.
Participants who are pregnant or breastfeeding.
Participants with any condition that affects the liver or kidneys, which are organs that help process and remove substances from the body.
Participants with any significant heart problems, which are issues affecting the heart’s function.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Fvxoyjedh Pqre Lq Izqyxtcgbasfa Bunnlkime Dkn Hdsufvrj Ufnunctfmytpo Lr Plg	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

CT001 is a combination of two medications used to manage moderate to severe pain in children. It includes a medication that helps relieve pain and another that enhances the pain-relieving effects. This combination is being studied to ensure it is safe and well-tolerated by children in acute care settings, such as hospitals, where quick and effective pain management is crucial. The study aims to determine how well this combination works in reducing pain and if it can be used safely in young patients.

Investigated diseases:

Pain

Pain – Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It can be acute, occurring suddenly and usually resolving once the underlying cause is treated, or chronic, persisting over a longer period. Pain can vary in intensity from mild to severe and may be described as sharp, dull, throbbing, or burning. It can affect any part of the body and may be accompanied by other symptoms such as swelling, redness, or stiffness. The perception of pain is subjective and can be influenced by various factors, including emotional state and previous experiences. Understanding and measuring pain accurately is crucial for effective management and relief.

Trial ID:

2023-504023-63-00

Protocol code:

PDC 01-0202

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Pain Relief of Nasal Spray with Ketamine Hydrochloride and Sufentanil Citrate for Children with Moderate to Severe Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?