search
Back to results

Clonidine and Morphine in Caudal Anesthesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Clonidine
Morphine
Bupivacaine plus clonidine and morphine
Bupivacaine
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring caudal anesthesia, clonidine, morphine, bupivacaine

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Cutaneous infection in puncture site

Sites / Locations

  • Santa Casa de Belo Horizonte Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

B

C

M

CM

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

The overall postoperative consumption of analgesics.

Secondary Outcome Measures

The peroperative consumption of volatile anesthetics.
The peroperative Bispectral Index measure.
Postoperative Wong-Baker faces scale
Postoperative pain and discomfort score scale

Full Information

First Posted
May 2, 2008
Last Updated
March 18, 2010
Sponsor
Federal University of Minas Gerais
Collaborators
Santa Casa de Misericórdia de Belo Horizonte
search

1. Study Identification

Unique Protocol Identification Number
NCT00672347
Brief Title
Clonidine and Morphine in Caudal Anesthesia
Official Title
Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Santa Casa de Misericórdia de Belo Horizonte

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
caudal anesthesia, clonidine, morphine, bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Description
compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
Arm Title
C
Arm Type
Active Comparator
Arm Description
compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
Arm Title
M
Arm Type
Active Comparator
Arm Description
compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine
Arm Title
CM
Arm Type
Active Comparator
Arm Description
compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
1 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
20 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine plus clonidine and morphine
Intervention Description
bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
Primary Outcome Measure Information:
Title
The overall postoperative consumption of analgesics.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The peroperative consumption of volatile anesthetics.
Time Frame
3 hours
Title
The peroperative Bispectral Index measure.
Time Frame
3 hours
Title
Postoperative Wong-Baker faces scale
Time Frame
24 hours
Title
Postoperative pain and discomfort score scale
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urogenital pediatric surgery Status physical(ASA) 1 and 2 Exclusion Criteria: Cutaneous infection in puncture site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato S Gomez, PhD, MD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magda L Fernandes, M
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa de Belo Horizonte Hospital
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16094063
Citation
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.
Results Reference
background
PubMed Identifier
10084100
Citation
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.
Results Reference
background
PubMed Identifier
17513626
Citation
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.
Results Reference
background

Learn more about this trial

Clonidine and Morphine in Caudal Anesthesia

We'll reach out to this number within 24 hrs