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Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT00532662
Recruitment Status : Unknown
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 20, 2007
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE September 19, 2007
First Posted Date  ICMJE September 20, 2007
Last Update Posted Date November 18, 2010
Study Start Date  ICMJE November 2007
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
pain score [ Time Frame: 24 hours after anesthesia ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
analgesic request [ Time Frame: 24 hours after anesthesia ]
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 Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery
Official Title  ICMJE Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
Brief Summary Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.
Detailed Description After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Analgesia
Intervention  ICMJE Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
Study Arms  ICMJE
  • Experimental: 1
    epidural s(+)-ketamine for supplementation of caudal anesthesia
    Intervention: Drug: S(+)-ketamine
  • Active Comparator: 2
    intravenous ketamine for supplementation of caudal anesthesia
    Intervention: Drug: S(+)-ketamine
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 19, 2007)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children aged < = 12 years
  • Children scheduled for elective orthopedic surgery with caudal block
  • ASA score < = 3

Exclusion Criteria:

  • Contraindication for caudal block such as vertebral defect or infection at the site of block
  • Disagreement of parents
  • Patient's age > 12 years
  • ASA score > = 4
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00532662
Other Study ID Numbers  ICMJE 86-02-78-56790
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HamidReza Amiri/Assistant professor, TehranUMS
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ramin Espandar, MD Imam Khomeini hospital- tehran university of medical sciences
PRS Account Tehran University of Medical Sciences
Verification Date November 2010

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