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Clonidine and Morphine in Caudal Anesthesia

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ClinicalTrials.gov Identifier: NCT00672347
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : March 19, 2010
Sponsor:
Collaborator:
Santa Casa de Misericórdia de Belo Horizonte
Information provided by:
Federal University of Minas Gerais

Tracking Information
First Submitted Date  ICMJE May 2, 2008
First Posted Date  ICMJE May 6, 2008
Last Update Posted Date March 19, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
The overall postoperative consumption of analgesics. [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00672347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
  • The peroperative consumption of volatile anesthetics. [ Time Frame: 3 hours ]
  • The peroperative Bispectral Index measure. [ Time Frame: 3 hours ]
  • Postoperative Wong-Baker faces scale [ Time Frame: 24 hours ]
  • Postoperative pain and discomfort score scale [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clonidine and Morphine in Caudal Anesthesia
Official Title  ICMJE Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Clonidine
    1 mcg/kg
  • Drug: Morphine
    20 mcg/kg
  • Drug: Bupivacaine plus clonidine and morphine

    bupivacaine 0,166% 1 ml/kg

    clonidine 1 mcg/kg

    morphine 20 mcg/kg

  • Drug: Bupivacaine
    Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
Study Arms  ICMJE
  • Active Comparator: B
    compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
    Intervention: Drug: Bupivacaine
  • Active Comparator: C
    compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
    Intervention: Drug: Clonidine
  • Active Comparator: M
    compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine
    Intervention: Drug: Morphine
  • Active Comparator: CM
    compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
    Intervention: Drug: Bupivacaine plus clonidine and morphine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Cutaneous infection in puncture site
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00672347
Other Study ID Numbers  ICMJE 210665
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Renato Santiago Gomez - PhD,MD, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Santa Casa de Misericórdia de Belo Horizonte
Investigators  ICMJE
Study Director: Renato S Gomez, PhD, MD Federal University of Minas Gerais
Principal Investigator: Magda L Fernandes, M Federal University of Minas Gerais
PRS Account Federal University of Minas Gerais
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP