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Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room

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ClinicalTrials.gov Identifier: NCT05057689
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.


Condition or disease Intervention/treatment Phase
Acute Stress Disorder Anxiety Pain Drug: Intranasal Dexmedetomidine (4 mcg/kg) Drug: Intranasal Fentanyl (2 mcg/kg) Drug: Intranasal Midazolam (5 mg/kg) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomized Trial Comparing the Safety & Efficacy of Intranasal Dexmedetomidine, Intranasal Fentanyl & Intranasal Midazolam in the Pediatric Emergency Room
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: 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.
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 prior to laceration repair. The maximum dose will be 200 mcg.
Other Name: Precedex

Experimental: 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.
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 prior to laceration repair. The maximum dose will be 100 mcg.
Other Name: Fentanyl Citrate

Experimental: 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
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 prior to laceration repair. The maximum dose will be 10 mg.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    Proceduralist will be asked to complete a follow-up survey to provide feedback on the level of satisfaction with the laceration repair experience.



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05057689


Contacts
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Contact: Jonathan Chang, MD 501-364-1050 JChang3@uams.edu

Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Contact: Jonathan Chang, MD    501-364-1050    jchang3@uams.edu   
Principal Investigator: Jonathan Chang, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Jonathan Chang, MD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT05057689    
Other Study ID Numbers: 261081
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Stress Disorders, Traumatic, Acute
Disease Attributes
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Fentanyl
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Anxiety Agents