NCT00287326

Brief Summary

The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
terminated

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, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 19, 2016

Status Verified

June 1, 2009

First QC Date

February 3, 2006

Last Update Submit

April 15, 2016

Conditions

Pain

Keywords

EpiduralBupivacaineClonidine

Outcome Measures

Primary Outcomes (1)

  • 24 hour recording of pain, sedation, narcotic usage, and satisfaction.

Interventions

Bupivacaine, Clonidine, MorphineDRUG

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 4-16
  • English speaking
  • Elective lower extremity osteotomy
  • Expected length of stay greater than 24 hours

You may not qualify if:

  • History of previous spine surgery
  • Current infection overlying catheter insertion site
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineClonidineMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael J Stella, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

January 1, 2006

Study Completion

June 1, 2006

Last Updated

April 19, 2016

Record last verified: 2009-06

Locations

US(1)