NCT00654511

Brief Summary

The primary purpose of this study is:

  1. 1.To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
  2. 2.To determine an analgesic dose response relationship for dexmedetomidine.
  3. 3.Compare recovery characteristics of dexmedetomidine to fentanyl.

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 Jan 2005

Longer than P75 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

January 1, 2005

Completed
3.3 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 26, 2011

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

3.8 years

First QC Date

April 3, 2008

Results QC Date

February 23, 2011

Last Update Submit

March 1, 2021

Conditions

Tonsillitis

Keywords

Dexmedetomidine,fentanyl,tonsillectomyand adenoidectomy,

Outcome Measures

Primary Outcomes (2)

  • Time to First Morphine Dose

    Total minutes from study medication administration to time of first morphine dose.

    up to 24 hours

  • Morphine Rescue

    Total morphine administered in the Post Anesthesia Care Unit (PACU)

    up to 24 hours

Study Arms (4)

Fentanyl 1

ACTIVE COMPARATOR

Fentanyl 1 micrograms (mcg)/kilogram (kg)

Drug: Fentanyl

Fentanyl 2

ACTIVE COMPARATOR

Fentanyl 2 micrograms (mcg)/kilogram (kg)

Drug: Fentanyl

Dex 3

EXPERIMENTAL

Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)

Drug: Dexmedetomidine

Dex 4

EXPERIMENTAL

Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)

Drug: Dexmedetomidine

Interventions

FentanylDRUG

Fentanyl 1mcg/kg, Intravenous (IV)

Also known as: Actiq
Fentanyl 1
DexmedetomidineDRUG

Dexmedetomidine, 2mcg/kg, Intravenous (IV)

Also known as: Precedex
Dex 3

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All of the following criteria must be met for the potential subject to be eligible for participation:
  • The subject is 2 to 12 years of age
  • The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
  • The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
  • The subject will be hospitalized overnight after surgery
  • The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent 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
  • The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
  • The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).

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

Related Publications (1)

  • Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.

    PMID: 21461792DERIVED

MeSH Terms

Conditions

Tonsillitis

Interventions

FentanylDexmedetomidine

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Results Point of Contact

Title
Julia 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, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 8, 2008

Study Start

January 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 23, 2021

Results First Posted

April 26, 2011

Record last verified: 2021-03

Locations

US(1)