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Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy

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ClinicalTrials.gov Identifier: NCT01041378
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : June 16, 2010
Sponsor:
Information provided by:
Yonsei University

Study Description
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Brief Summary:
The purpose of this study is to evaluate postoperative pain control for pediatric patients.

Condition or disease Intervention/treatment Phase
Pain Drug: dexamethasone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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Arms and Interventions
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Intervention Details:
  • Drug: dexamethasone
    Intravenous dexamethasone (0.5mg/kg) before incision

Outcome Measures
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Primary Outcome Measures :
  1. Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC [ Time Frame: postoperative 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients scheduled for elective day-case orchiopexy.

Exclusion Criteria:

  • Infants or children with history of steroid allergy, renal, hepatic disease, or contraindication for caudal analgesia.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kil Hae Keum / Professor of Anesthesiology and Pain Medicine at Severance Hospital, Yonsei University Health System
ClinicalTrials.gov Identifier: NCT01041378    
Other Study ID Numbers: 4-2009-0558
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: May 2010
Keywords provided by Yonsei University:
Pediatric patients (6 months-5 years) scheduled elective day-case orchiopexy
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents