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The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081535
First Posted: March 5, 2010
Last Update Posted: March 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
March 4, 2010
March 5, 2010
March 5, 2010
May 2009
February 2010   (Final data collection date for primary outcome measure)
Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC [ Time Frame: postoperative 24 hours, 48hours ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Ureteroneocystostomy
Drug: ketorolac, fentanyl
intravenous PCA
  • Experimental: ketorolac
    Intervention: Drug: ketorolac, fentanyl
  • Experimental: fentanyl
    Intervention: Drug: ketorolac, fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pediatric patients scheduled for elective ureteroneocystostomy were enrolled.

Exclusion Criteria:

  • History of allergy to aspirin or NSAIDs
  • Peptic ulcer disease, and renal function impairment.
  • And local infection foci on back, spinal anomalies
  • Infectious diseases
  • Neurologic disorders
  • Seizures and coagulopathies were excluded for sacral epidural block.
Sexes Eligible for Study: All
6 Months to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01081535
4-2009-0107
Yes
Not Provided
Not Provided
Kil Hae Keum/professor, Yonsei University, College of Medicine
Yonsei University
Not Provided
Principal Investigator: Hae Keum Kil Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
Yonsei University
January 2010

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