Clonidine and Morphine in Caudal Anesthesia

NCT ID: NCT00672347

Last Updated: 2010-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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B

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

C

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

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

1 mcg/kg

M

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

20 mcg/kg

CM

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

Group Type ACTIVE_COMPARATOR

Bupivacaine plus clonidine and morphine

Intervention Type DRUG

bupivacaine 0,166% 1 ml/kg

clonidine 1 mcg/kg

morphine 20 mcg/kg

Interventions

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Clonidine

1 mcg/kg

Intervention Type DRUG

Morphine

20 mcg/kg

Intervention Type DRUG

Bupivacaine plus clonidine and morphine

bupivacaine 0,166% 1 ml/kg

clonidine 1 mcg/kg

morphine 20 mcg/kg

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cutaneous infection in puncture site
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santa Casa de Misericórdia de Belo Horizonte

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Minas Gerais

Principal Investigators

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Renato S Gomez, PhD, MD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Magda L Fernandes, M

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Santa Casa de Belo Horizonte Hospital

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 16094063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10084100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17513626 (View on PubMed)

Other Identifiers

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210665

Identifier Type: -

Identifier Source: org_study_id

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