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Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures

NCT03220880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 578

Last updated 2021-09-10

No results posted yet for this study

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.

Conditions

  • Dexmedetomidine
  • Sedation

Interventions

DRUG

Intranasal dexmedetomidine

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

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • UNC Children's Hospital

    collaborator UNKNOWN

  • Santa Clara Valley Medical Center

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • HSHS St. John's Hospital

    collaborator UNKNOWN

  • Boston Children's Hospital

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Daniel S Tsze, MD, MPH · Columbia University

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-01-31
Completion
2020-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220880 on ClinicalTrials.gov