NCT01057381

Brief Summary

The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 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

August 1, 2005

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10.2 years until next milestone

Results Posted

Study results publicly available

February 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

5.3 years

First QC Date

January 25, 2010

Results QC Date

January 12, 2021

Last Update Submit

July 23, 2021

Conditions

Pediatric AdenotonsillectomyPost Operative Analgesia

Keywords

AdenotonsillectomyPostoperative analgesiaPediatrics

Outcome Measures

Primary Outcomes (1)

  • Amount of Post-Operative Rescue Morphine Required for Analgesia

    From admission to discharge from PACU, up to 1 hour

Secondary Outcomes (5)

  • Morphine Rescue Doses Needed by Participants

    From admission to discharge from PACU, up to 1 hour

  • Duration of Oxygen Supplementation

    From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes

  • Time to PACU Discharge Readiness

    From admission to discharge from PACU, no time limit

  • Number of Participants With Emergence Agitation

    From admission to discharge from PACU, no time limit

  • Number of Participants With Postoperative Complications

    From admission to discharge from PACU, up to 1 hour

Study Arms (4)

Dexmedetomidine 0.75 mcg/kg

ACTIVE COMPARATOR

Intraoperative administration for analgesia.

Drug: Dexmedetomidine 0.75 mcg/kg

Dexmedetomidine 1mcg/kg

ACTIVE COMPARATOR

Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia

Drug: Dexmedetomidine 1 mcg/kg

Morphine 50 mcg/kg

ACTIVE COMPARATOR

Intra-operative administration of morphine 50 mcg/kg for analgesia

Drug: Morphine 50 mcg/kg

Morphine 100mcg/kg

ACTIVE COMPARATOR

Intra-operative administration of morphine 100mcg/kg for analgesia

Drug: Morphine 100 mcg/kg

Interventions

Dexmedetomidine 0.75 mcg/kgDRUG

Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.

Also known as: Precedex
Dexmedetomidine 0.75 mcg/kg
Morphine 50 mcg/kgDRUG

Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia

Also known as: Morphine
Morphine 50 mcg/kg
Morphine 100 mcg/kgDRUG

Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia

Also known as: Morphine
Morphine 100mcg/kg
Dexmedetomidine 1 mcg/kgDRUG

Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia

Also known as: Precedex
Dexmedetomidine 1mcg/kg

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

You may not qualify if:

  • Children less than 3 years
  • Children with uncorrected cardiac lesions
  • Children with heart block or liver impairment
  • Children with American Society of Anesthesiology Class 3 or 4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

DexmedetomidineMorphine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

We studied a relatively healthy patient population and excluded children with documented sleep apnea by polysomnography.

Results Point of Contact

Title
Olutoyin A. Olutoye, M.D., M.Sc.
Organization
Baylor College of Medicine
oao@bcm.edu
(832) 824-5800

Study Officials

  • Olutoyin A Olutoye, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology & Pediatrics

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 27, 2010

Study Start

August 1, 2005

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

July 27, 2021

Results First Posted

February 1, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)