Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures

Clinical Characteristics of Intranasal Dexmedetomidine for Sedation in Children Undergoing Non-painful Procedures

Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens are effective for producing sedation adequate for completion of non-painful procedures in children.

Specific Aim 2: To describe the temporal characteristics associated with varied regimens of IN DEX in children undergoing non-painful procedures, such as time to onset of adequate sedation; time to procedure start; and time from procedure end to meeting discharge criteria. This aim will test the working hypothesis that IN DEX regimens have temporal characteristics that are favourable for sedating children for non-painful procedures.

Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in children undergoing non-painful procedures. This aim will test the working hypothesis that IN DEX regimens have a low incidence of adverse events.

Study Overview

• Status: Completed
• Conditions: Sedation; Dexmedetomidine
• Intervention / Treatment: Drug: Intranasal dexmedetomidine

Detailed Description

Dexmedetomidine (DEX) is an alpha-2 receptor agonist with sedative, anxiolytic, and analgesics properties. DEX has been used extensively for sedation in children to facilitate different non-painful procedures, such magnetic resonance imaging (MRI), auditory brainstem response (ABR) tests, and computed tomography (CT) scans. In particular, DEX can be administered by the intranasal (IN) route. Intranasal administration has the benefits of being both effective and needle-free, of which the latter makes it less distressing to children compared to sedatives administered by the intravenous (IV) route. There is a gap of knowledge, however, regarding the ideal regimen of IN DEX for providing optimal procedural sedation in children undergoing non-painful procedures. There is a large variation in practice using IN DEX, both regarding the dose and the use of adjunct medications. It is also unknown whether regimens should vary based on patient factors such as age. There is no clear evidence to define best practice when using IN DEX to provide sedation in this population to achieve the desired outcomes most relevant to clinicians. The rationale of the proposed investigation is that by conducting an exploratory study to measure clinical outcomes associated with IN DEX, the investigators can begin to identify trends and differences that will lay the foundation for randomized clinical trials to identify the ideal regimen for IN DEX when providing sedation for non-painful procedures. This will then allow the investigators to compare IN DEX, at its best, to other sedatives so that the sedative and regimen associated with the best outcomes relevant to sedation of children undergoing non-painful procedures can be determined.

• Study Type: Observational
• Enrollment (Actual): 578

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
  • Illinois
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University Healthcare
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children undergoing sedation using intranasal dexmedetomidine for non-painful procedures.

Description

Inclusion Criteria:

• Children 2 months to 17 years (i.e. before their 18th birthday)
• Child will be receiving intranasal dexmedetomidine as part of their usual medical care
• Child will be undergoing a non-painful medical procedure, which includes (but is not limited to): MRI, CT scans, ABR/BAER, echocardiograms, and EEGs.

Exclusion Criteria:

• Known allergy to dexmedetomidine
• Known abnormal renal or hepatic function
• Known cardiac conduction abnormality or heart block
• Current use of digoxin or beta-blockers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intranasal dexmedetomidine; Intranasal dexmedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg	Drug: Intranasal dexmedetomidine; Intranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of sedation	Pediatric Sedation State Scale	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of adequate sedation	Time in minutes after administration of IN DEX to achieve a University of Michigan Sedation Scale (UMSS) score of 3 or more	1 hour
Time to discharge	Time in minutes after procedure end to achieving Modified Aldrete Scoring System (MASS) score of 9 or greater, or baseline MASS score.	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events and/or required interventions (e.g. cardiovascular, airway) required	3 hours

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Baylor College of Medicine; University of Pittsburgh; Boston Children's Hospital; Children's Hospital Medical Center, Cincinnati; Children's Healthcare of Atlanta; Santa Clara Valley Medical Center; UNC Children's Hospital; HSHS St. John's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric; Sedation; Dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: AAAR5010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No