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Intranasal Sedation for Pediatric Emergency Room
Study Summary
This trial is testing whether a drug called dexmedetomidine is more effective than fentanyl or midazolam at reducing pain and anxiety during a laceration repair.
- Pain
- Anxiety
- Acute Stress Disorder
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a problem with the shape or structure of your nose.You have had a serious negative reaction to fentanyl or midazolam in the past, such as seizures, unusual reactions, or hallucinations.You have conditions that may affect your ability to feel pain such as autism or severe sensory-neural disturbances.You cannot take pain medication or anxiety medication (except for ibuprofen or acetaminophen) 4 hours before the examination.You have a history of irregular heartbeats.You have a cut or an injury caused by a tear in the skin.You have had a bad reaction to sedation or anesthesia in the past.You have previously had an allergic reaction to fentanyl, midazolam, or dexmedetomidine.
- Group 1: Intranasal Dexmedetomidine (4 mcg/kg)
- Group 2: Intranasal Fentanyl (2 mcg/kg)
- Group 3: Intranasal Midazolam (5 mg/kg)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the FDA's official stance on Intranasal Fentanyl (2 mcg/kg)?
"Intranasal Fentanyl (2 mcg/kg) is still in Phase 2 of clinical trials, so while there is evidence supporting its safety, there is none yet for efficacy. Our team scored it a 2."
When is Intranasal Fentanyl (2 mcg/kg) most often prescribed?
"Intranasal Fentanyl (2 mcg/kg) is the standard medication used to treat anxiolysis. However, it can also be employed in other high risk medical situations such as status epilepticus and surgery where anxiety levels are usually quite high."
How does the use of Intranasal Fentanyl (2 mcg/kg) compare to other drugs in clinical trials?
"211 clinical trials are still underway for Intranasal Fentanyl (2 mcg/kg), with 44 of them in Phase 3 testing. Many Porto Alegre, California facilities have completed their research but there are 1,016 locations worldwide where studies surrounding the medication are still being conducted."
What is the participant pool size for this research?
"Although this study is no longer recruiting, it was last edited on July 11th, 2022. For other studies, 936 are currently looking for patients with stress disorder and 211 are actively admitting patients for Intranasal Fentanyl (2 mcg/kg)."
Is this trial accessible to patients who are above the age of 40?
"The specific age group that this clinical trial is looking for are children aged 2 to 6. Out of the 1,089 other ongoing studies, 256 focus on a similar age bracket and 833 deal with patients outside of the pediatric demographic."
Are people still being enrolled in this clinical trial?
"This trial, which was last updated on July 11th 2022, is not presently recruiting patients. However, there are other ongoing trials that may be of interest and are actively enrolling participants."
How can I participate in this research project?
"The investigators running this study are looking for young patients, aged 2-6 years old, who have a primary complaint of stress disorder and initial presented at the Arkansas Children's Hospital Emergency Department. A total of 180 participants are needed to complete this research project."
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