NCT00672347

Brief Summary

Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_1 postoperative-pain

Timeline
Completed

Started Jul 2008

Typical duration for phase_1 postoperative-pain

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

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 19, 2010

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

May 2, 2008

Last Update Submit

March 18, 2010

Conditions

Postoperative Pain

Keywords

caudal anesthesia, clonidine, morphine, bupivacaine

Outcome Measures

Primary Outcomes (1)

  • The overall postoperative consumption of analgesics.

    24 hours

Secondary Outcomes (4)

  • The peroperative consumption of volatile anesthetics.

    3 hours

  • The peroperative Bispectral Index measure.

    3 hours

  • Postoperative Wong-Baker faces scale

    24 hours

  • Postoperative pain and discomfort score scale

    24 hours

Study Arms (4)

B

ACTIVE COMPARATOR

compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both

Drug: Bupivacaine

C

ACTIVE COMPARATOR

compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine

Drug: Clonidine

M

ACTIVE COMPARATOR

compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine

Drug: Morphine

CM

ACTIVE COMPARATOR

compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine

Drug: Bupivacaine plus clonidine and morphine

Interventions

ClonidineDRUG

1 mcg/kg

C
MorphineDRUG

20 mcg/kg

M
Bupivacaine plus clonidine and morphineDRUG

bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg

CM
BupivacaineDRUG

Caudal anesthesia with bupivacaine 0,166% 1 ml/kg

B

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Urogenital pediatric surgery
  • Status physical(ASA) 1 and 2

You may not qualify if:

  • Cutaneous infection in puncture site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa de Belo Horizonte Hospital

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (3)

  • Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.

    PMID: 16094063BACKGROUND

  • Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6. doi: 10.1046/j.1365-2346.1999.00430.x.

    PMID: 10084100BACKGROUND

  • Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.

    PMID: 17513626BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

ClonidineMorphineBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Renato S Gomez, PhD, MD

    Federal University of Minas Gerais

    STUDY DIRECTOR

  • Magda L Fernandes, M

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2009

Last Updated

March 19, 2010

Record last verified: 2010-03

Locations

BR(1)