Acute Stress DisorderPhase 2NCT05057689
Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
A Phase 2 study testing Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg) and Intranasal Midazolam (5 mg/kg) in people with Acute Stress Disorder and Anxiety, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Disorder, Anxiety, Pain
- What is being tested?
- Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg) and Intranasal Midazolam (5 mg/kg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary complaint of "laceration"
- 2 years to 6 years of age (inclusive)
- Initial presentation at the Arkansas Children's Hospital (ACH) Emergency Department
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: A Double-blinded, Randomized Trial Comparing the Safety & Efficacy of Intranasal Dexmedetomidine, Intranasal Fentanyl & Intranasal Midazolam in the Pediatric Emergency Room
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.
Read the detailed description
Intranasal medications are rapidly gaining popularity as agents for analgesia and anxiolysis in the pediatric hospital setting. One of the primary reasons for the popularity of intranasal medications is ease of administration combined with favorable pharmacokinetics. It has been well established that children identify venipuncture as one of the most painful and anxiety-producing procedures during time spent in the hospital, and these experiences have been shown to have a more lasting impact, producing increased anxiety and fear at subsequent visits. Although oral and rectal administration of analgesics are also non-invasive, bioavailability, time to onset, and half-lives are significantly longer with these routes of administration in comparison to intranasal administration. Multiple studies have shown that intranasal fentanyl, midazolam, and dexmedetomidine have similar pharmacokinetics to intravenous preparations and reach adequate serum levels in both the blood and cerebrospinal fluid. In the pediatric emergency room setting, intranasal fentanyl and midazolam have been shown to provide effective analgesia and anxiolysis for a variety of settings, including pain management (e.g. pain associated with long bone fractures, burns, incision and drainage) and pre-procedural sedation/anxiolysis (e.g. radiological imaging).Numerous studies have examined the safety and efficacy of intranasal fentanyl and midazolam, and several studies have examined the efficacy of intranasal dexmedetomidine for non-painful procedural sedation. To date, two studies have compared the use of intranasal dexmedetomidine and intranasal midazolam or intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam for anxiolysis in painful procedural sedations. However, as of 2020, no previous studies have compared the use of intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam for painful procedures in the pediatric emergency setting.
- Conditions
- Acute Stress Disorder, Anxiety, Pain
- Being tested
- Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg), Intranasal Midazolam (5 mg/kg)
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Dexmedetomidine (4 mcg/kg)Drug
Also called Precedex
Dexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 200 mcg.
Intranasal Fentanyl (2 mcg/kg)Drug
Also called Fentanyl Citrate
Fentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 100 mcg.
Intranasal Midazolam (5 mg/kg)Drug
Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 10 mg.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Dexmedetomidine (4 mcg/kg) | Experimental | Dexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart. The maximum dose will be 200 mcg. Receives: Drug: Intranasal Dexmedetomidine (4 mcg/kg) |
| Intranasal Fentanyl (2 mcg/kg) | Experimental | Fentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart. The maximum dose will be 100 mcg. Receives: Drug: Intranasal Fentanyl (2 mcg/kg) |
| Intranasal Midazolam (5 mg/kg) | Experimental | Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart. The maximum dose will be 10 mg Receives: Drug: Intranasal Midazolam (5 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Analgesia in subjects undergoing simple laceration repair will be compared across the three investigational drug products (intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam) using the FLACC scale.
Measured: through the procedure, an average of 1 day
Anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool
Anxiolysis in subjects undergoing simple laceration repair will be compared across the three investigational drug products (intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam) using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool.
Measured: through the procedure, an average of 1 day
Secondary outcomes (2)
Satisfaction rates for subject experience across the three study drugs based on parent/legally authorized representative (LAR) survey
Parent/LAR will be asked to complete a follow-up survey so that parent/LAR can provide feedback on the level of satisfaction with the laceration repair experience.
Measured: within 1 week of the laceration repair, average of 5 days
Satisfaction rates for surgical repair across the three study drugs based on proceduralist survey
Proceduralist will be asked to complete a follow-up survey to provide feedback on the level of satisfaction with the laceration repair experience.
Measured: within 1 week of the laceration repair, average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study startSep 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Unable to obtain funding to initiate/complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress DisorderStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Chang, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057689
- Sponsor's protocol ID
- 261081
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2021
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized Trial Comparing the Safety & Efficacy of Intranasal Dexmedetomidine, Intranasal Fentanyl & Intranasal Midazolam in the Pediatric Emergency Room
- ClinicalTrials.gov ID
- NCT05057689
- Acronym / sponsor ID
- 261081
- Conditions
- Acute Stress Disorder, Anxiety, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding to initiate/complete study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intranasal medications are rapidly gaining popularity as agents for analgesia and anxiolysis in the pediatric hospital setting. One of the primary reasons for the popularity of intranasal medications is ease of administration combined with favorable pharmacokinetics. It has been well established that children identify venipuncture as one of the most painful and anxiety-producing procedures during time spent in the hospital, and these experiences have been shown to have a more lasting impact, producing increased anxiety and fear at subsequent visits. Although oral and rectal administration of analgesics are also non-invasive, bioavailability, time to onset, and half-lives are significantly longer with these routes of administration in comparison to intranasal administration. Multiple studies have shown that intranasal fentanyl, midazolam, and dexmedetomidine have similar pharmacokinetics to intravenous preparations and reach adequate serum levels in both the blood and cerebrospinal fluid. In the pediatric emergency room setting, intranasal fentanyl and midazolam have been shown to provide effective analgesia and anxiolysis for a variety of settings, including pain management (e.g. pain associated with long bone fractures, burns, incision and drainage) and pre-procedural sedation/anxiolysis (e.g. radiological imaging).Numerous studies have examined the safety and efficacy of intranasal fentanyl and midazolam, and several studies have examined the efficacy of intranasal dexmedetomidine for non-painful procedural sedation. To date, two studies have compared the use of intranasal dexmedetomidine and intranasal midazolam or intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam for anxiolysis in painful procedural sedations. However, as of 2020, no previous studies have compared the use of intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam for painful procedures in the pediatric emergency setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Dexmedetomidine (4 mcg/kg) | Experimental | Drug: Intranasal Dexmedetomidine (4 mcg/kg)Dexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart. The maximum dose will be 200 mcg. |
| Intranasal Fentanyl (2 mcg/kg) | Experimental | Drug: Intranasal Fentanyl (2 mcg/kg)Fentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart. The maximum dose will be 100 mcg. |
| Intranasal Midazolam (5 mg/kg) | Experimental | Drug: Intranasal Midazolam (5 mg/kg)Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart. The maximum dose will be 10 mg |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary complaint of "laceration"
- 2 years to 6 years of age (inclusive)
- Initial presentation at the Arkansas Children's Hospital (ACH) Emergency Department
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Dexmedetomidine (4 mcg/kg)Also: PrecedexDexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 200 mcg. | Drug | Intranasal Dexmedetomidine (4 mcg/kg) |
| Intranasal Fentanyl (2 mcg/kg)Also: Fentanyl CitrateFentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 100 mcg. | Drug | Intranasal Fentanyl (2 mcg/kg) |
| Intranasal Midazolam (5 mg/kg)Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 10 mg. | Drug | Intranasal Midazolam (5 mg/kg) |
Primary outcome
Pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: through the procedure, an average of 1 day
Analgesia in subjects undergoing simple laceration repair will be compared across the three investigational drug products (intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam) using the FLACC scale.
Anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool
Time frame: through the procedure, an average of 1 day
Anxiolysis in subjects undergoing simple laceration repair will be compared across the three investigational drug products (intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam) using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool.
2 secondary outcomes
Satisfaction rates for subject experience across the three study drugs based on parent/legally authorized representative (LAR) survey
Time frame: within 1 week of the laceration repair, average of 5 days
Satisfaction rates for surgical repair across the three study drugs based on proceduralist survey
Time frame: within 1 week of the laceration repair, average of 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Chang, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg) and Intranasal Midazolam (5 mg/kg) in people with Acute Stress Disorder and Anxiety, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale (time frame: through the procedure, an average of 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.