NCT00654329

Brief Summary

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 25, 2011

Completed
Last Updated

April 25, 2011

Status Verified

March 1, 2011

Enrollment Period

3.3 years

First QC Date

April 3, 2008

Results QC Date

February 23, 2011

Last Update Submit

March 28, 2011

Conditions

Otitis

Keywords

Dexmedetomidine, transmucosal, myringotomy,

Outcome Measures

Primary Outcomes (1)

  • Incidence of Pain

    Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

    up to 24 hours

Secondary Outcomes (1)

  • Length of Stay in PACU

    up to 24 hours

Study Arms (4)

Dexmedetomidine 1microgram/kilogram

EXPERIMENTAL

Dexmedetomidine 1microgram/kilogram intranasal

Drug: Dexmedetomidine

Dexmedetomidine 2 micrograms/kilogram

EXPERIMENTAL

Dexmedetomidine 2 micrograms/kilogram intranasal

Drug: Dexmedetomidine

Fentanyl 2 micrograms/kilogram

ACTIVE COMPARATOR

Fentanyl 2 micrograms/kilogram intranasal

Drug: Fentanyl

Normal saline placebo

PLACEBO COMPARATOR

Normal saline placebo intranasal

Drug: Saline

Interventions

SalineDRUG

Normal saline, given intranasally

Also known as: Normal Saline
Normal saline placebo
FentanylDRUG

Fentanyl, nasal transmucosal, 2 micrograms/kilogram

Also known as: Actiq, Fentora
Fentanyl 2 micrograms/kilogram
DexmedetomidineDRUG

Dexmedetomidine, transmucosal, 1 microgram/kilogram

Also known as: Precedex
Dexmedetomidine 1microgram/kilogram

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The subject is 6 months to 6 years of age
  • The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
  • The subject is scheduled for elective bilateral myringotomy with tube placement
  • The subject's parent/legally authorized guardian has given written informed consent to participate

You may not qualify if:

  • The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  • The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
  • The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
  • The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
  • The subject has know central nervous system disease or neurological impairment
  • The subject is an ASA classification of 3 or greater (See Appendix 1)
  • The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
  • The subject refuses inhalation induction
  • The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Otitis

Interventions

Sodium ChlorideSaline SolutionFentanylDexmedetomidine

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Results Point of Contact

Title
Julia C. Finkel, MD
Organization
Children's National Medical Center
jfinkel@cnmc.org
202-476-4867

Study Officials

  • Julia C Finkel, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 8, 2008

Study Start

August 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 25, 2011

Results First Posted

April 25, 2011

Record last verified: 2011-03

Locations

US(1)