BridgeMD
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
EU CTIS ID: 2023-504023-63-00
What this study is testing
To assess the safety and tolerability of CT001 in pediatric participants with moderate to severe pain in an acute care setting. To evaluate the analgesic effect of CT001 in pediatric participants with moderate to severe pain in an acute care setting.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pediatric participant, age 1 year to 17 years.
- Attending an Emergency Department (ED) following an injury.
- Acute pain of moderate or severe intensity (corresponding to 5 or above on an age-appropriate pain scale (0-10 NRS, Wong-Baker FACES scale and FLACC pain scale)
- Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)
You likely can't join if
- Critical, life- or limb-threatening condition requiring immediate management.
- Known pregnancy or breastfeeding females.
- Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
- Abnormal nasal cavity or nasal obstruction.
- Known or suspected allergy to ketamine or sufentanil.
- Has received treatment with sufentanil and/or ketamine during the last 72 hours.
See the full eligibility criteria
- Pediatric participant, age 1 year to 17 years.
- Attending an Emergency Department (ED) following an injury.
- Acute pain of moderate or severe intensity (corresponding to 5 or above on an age-appropriate pain scale (0-10 NRS, Wong-Baker FACES scale and FLACC pain scale)
- Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)
- Critical, life- or limb-threatening condition requiring immediate management.
- Known pregnancy or breastfeeding females.
- Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
- Abnormal nasal cavity or nasal obstruction.
- Known or suspected allergy to ketamine or sufentanil.
- Has received treatment with sufentanil and/or ketamine during the last 72 hours.
- Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device in the 4 weeks prior to signing the informed consent/assent for this trial.
- Previous enrolment in the present study.
- Open fractures.
- Participants with chronic pain.
- Participants requiring oxygen therapy.
- Clinically evident respiratory depression.
- Clinically evident cardiovascular instability (e.g. pathological arrhythmia).
- Known liver damage.
- Known significant renal impairment.
- Presence of other acute clinical or medical condition that may, in the opinion of the investigator, put the potential subject at risk when participating in the study, impact the participant’s ability to participate in the study, or have impact on the study results, including being subject to head injury and / or altered consciousness.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.