NCT03220880

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

July 14, 2017

Last Update Submit

September 8, 2021

Conditions

DexmedetomidineSedation

Keywords

DexmedetomidineSedationPediatric

Outcome Measures

Primary Outcomes (1)

  • Adequacy of sedation

    Pediatric Sedation State Scale

    1 hour

Secondary Outcomes (2)

  • Time to onset of adequate sedation

    1 hour

  • Time to discharge

    2 hours

Other Outcomes (1)

  • Adverse events

    3 hours

Study Arms (1)

Intranasal dexmedetomidine

Intranasal dexmedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg

Drug: Intranasal dexmedetomidine

Interventions

Intranasal dexmedetomidineDRUG

Intranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg

Intranasal dexmedetomidine

Eligibility Criteria

Age2 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Southern Illinois University Healthcare

Springfield, Illinois, 62794, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

UNC Children's Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Tsze DS, Rogers AP, Baier NM, Paquin JR, Majcina R, Phelps JR, Hollenbeck A, Sulton CD, Cravero JP. Clinical Outcomes Associated With Intranasal Dexmedetomidine Sedation in Children. Hosp Pediatr. 2023 Mar 1;13(3):223-243. doi: 10.1542/hpeds.2022-007007.

    PMID: 36810939DERIVED

Study Officials

  • Daniel S Tsze, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics in Emergency Medicine at CUMC

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

September 4, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations

US(8)