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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Analgesia Drug: S(+)-ketamine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
Study Start Date : November 2007
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
epidural s(+)-ketamine for supplementation of caudal anesthesia
 Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
Active Comparator: 2
intravenous ketamine for supplementation of caudal anesthesia
 Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. pain score [ Time Frame: 24 hours after anesthesia ]

Secondary Outcome Measures :
  1. analgesic request [ Time Frame: 24 hours after anesthesia ]

Eligibility Criteria
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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532662


Contacts
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Contact: Hamid Reza Amiri, MD 021-61192628 hramiri@gmail.com

Locations
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Iran, Islamic Republic of
orthopedic ward of Imam Khomeini hospital Recruiting
Tehran, Iran, Islamic Republic of, 1419733141
Contact: Ramin Espandar, MD    02161192627    espandarmd@sina.tums.ac.ir   
orthopedic surgery room- Imam Khomeini hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Siamak Yousef Sibdari, MD    021-61192627    sibdari@gmail.com   
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: Ramin Espandar, MD Imam Khomeini hospital- tehran university of medical sciences
More Information
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Responsible Party: HamidReza Amiri/Assistant professor, TehranUMS
ClinicalTrials.gov Identifier: NCT00532662    
Other Study ID Numbers: 86-02-78-56790
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010
Keywords provided by Tehran University of Medical Sciences:
Epidural
Intravenous
Ketamine
Analgesia
 Caudal
Pediatric
Regional
Local Anesthetics
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action