Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy

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

Tracking Information

• First Submitted Date: December 30, 2009
• First Posted Date: December 31, 2009
• Last Update Posted Date: June 16, 2010
• Study Start Date: January 2010
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 30, 2009): Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC [ Time Frame: postoperative 24 hours ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy
• Official Title: Not Provided
• Brief Summary: The purpose of this study is to evaluate postoperative pain control for pediatric patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator)
• Condition: Pain

Intervention

Drug: dexamethasone

Intravenous dexamethasone (0.5mg/kg) before incision

• Study Arms: Not Provided
• Publications *: Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 30, 2009): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2010
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01041378
• Other Study ID Numbers: 4-2009-0558
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kil Hae Keum / Professor of Anesthesiology and Pain Medicine at Severance Hospital, Yonsei University Health System
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: May 2010