Clinical trial NCT05057689: Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
Official title: A Double-blinded, Randomized Trial Comparing the Safety & Efficacy of Intranasal Dexmedetomidine, Intranasal Fentanyl & Intranasal Midazolam in the Pediatric Emergency Room
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Stress Disorder
Anxiety
Pain
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: through the procedure, an average of 1 day
measure: Anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool
timeFrame: through the procedure, an average of 1 day
Secondary outcomes:
measure: Satisfaction rates for subject experience across the three study drugs based on parent/legally authorized representative (LAR) survey
timeFrame: within 1 week of the laceration repair, average of 5 days
measure: Satisfaction rates for surgical repair across the three study drugs based on proceduralist survey
timeFrame: within 1 week of the laceration repair, average of 5 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jonathan Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: