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Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery (clonidine)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Clonidine 1 mcg/Kg
Clonidine 2 mcg/ Kg
Clonidine 3 mcg/ Kg
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Analgesia, Bupivacaine, Clonidine

Eligibility Criteria

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

Inclusion Criteria:

  • CHildren 1 - 10 years old.
  • ASA I E II ( American Society of Anesthesiology)
  • hypospadias surgery

Exclusion Criteria:

  • parents refuse
  • Infection
  • Coagulation disorders
  • Allergy to anesthetics
  • Abnormalities of the sacral spine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Bupivacaine 0,166%

    Clonidine 1 mcg/Kg

    Clonidine 2 mcg/ Kg

    Clonidine 3 mcg/Kg

    Arm Description

    General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery

    IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery

    IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery

    General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery

    Outcomes

    Primary Outcome Measures

    Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2015
    Last Updated
    May 12, 2016
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02769390
    Brief Title
    Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
    Acronym
    clonidine
    Official Title
    Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.
    Detailed Description
    It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Analgesia, Bupivacaine, Clonidine

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bupivacaine 0,166%
    Arm Type
    No Intervention
    Arm Description
    General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery
    Arm Title
    Clonidine 1 mcg/Kg
    Arm Type
    Active Comparator
    Arm Description
    IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery
    Arm Title
    Clonidine 2 mcg/ Kg
    Arm Type
    Active Comparator
    Arm Description
    IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
    Arm Title
    Clonidine 3 mcg/Kg
    Arm Type
    Active Comparator
    Arm Description
    General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Clonidine 1 mcg/Kg
    Other Intervention Name(s)
    Atensine
    Intervention Description
    Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Clonidine 2 mcg/ Kg
    Other Intervention Name(s)
    Atensine
    Intervention Description
    Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Clonidine 3 mcg/ Kg
    Other Intervention Name(s)
    Atensine
    Intervention Description
    Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
    Primary Outcome Measure Information:
    Title
    Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
    Time Frame
    24 hours after the surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CHildren 1 - 10 years old. ASA I E II ( American Society of Anesthesiology) hypospadias surgery Exclusion Criteria: parents refuse Infection Coagulation disorders Allergy to anesthetics Abnormalities of the sacral spine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ana claudia mota bonisson, M
    Organizational Affiliation
    Hospital da Baleia - Fundação Benjamim Guimaraes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22159880
    Citation
    Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
    Results Reference
    background
    PubMed Identifier
    22855315
    Citation
    Mauch J, Weiss M. [Pediatric caudal anesthesia: importance and aspects of safety concerns]. Schmerz. 2012 Aug;26(4):443-53; quiz 454. doi: 10.1007/s00482-012-1202-0. German.
    Results Reference
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    Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

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