Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency … (NCT05057689) | Clinical Trial Compass
WithdrawnPhase 2
Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
Stopped: Unable to obtain funding to initiate/complete study
United States0Started 2025-09
Plain-language summary
The hypothesis is that intranasal dexmedetomidine will provide significantly more effective analgesia and anxiolysis for subjects undergoing a simple laceration repair when compared to either intranasal fentanyl or intranasal midazolam.
Additional hypotheses include that there will be 1) no significant increase in adverse effects between drugs and 2) significantly higher satisfaction rates for both subject experience and ease of laceration repair based on structured, proceduralist feedback.
Who can participate
Age range
2 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary complaint of "laceration"
* 2 years to 6 years of age (inclusive)
* Initial presentation at the Arkansas Children's Hospital (ACH) Emergency Department
Exclusion Criteria:
* Prior allergic reaction to fentanyl or midazolam or dexmedetomidine
* Prior major adverse reaction to fentanyl or midazolam (e.g. seizure-like activity, paradoxical reaction, hallucinations)
* Nasal injury/deformity
* Potential for altered pain perception (e.g. autism, severe sensory-neural disturbances)
* History of adverse reaction to sedation/anesthesia
* History of cardiac arrhythmia
* History of liver dysfunction
* Concurrent injuries that would necessitate higher levels of care (e.g. inpatient admission, immediate evaluation in the operating room (OR), etc.)
* Complex (multi-layer) lacerations or those requiring subspecialty consultation for repair
* American Society of Anesthesiology (ASA) score ≥ 3
* Use of analgesics (with the exception of ibuprofen or acetaminophen) or anxiolytics in the immediate pre-examination period (within 4 hours)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Timeframe: through the procedure, an average of 1 day
2
Anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool
Timeframe: through the procedure, an average of 1 day