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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

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: dexamethasone
    Intravenous dexamethasone (0.5mg/kg) before incision


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 ]


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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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kil Hae Keum / Professor of Anesthesiology and Pain Medicine at Severance Hospital, Yonsei University Health System
ClinicalTrials.gov Identifier: NCT01041378     History of Changes
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:
Dexamethasone acetate
Dexamethasone
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action