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:

Information provided by:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01081535

First received: March 4, 2010

Last updated: NA

Last verified: January 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 4, 2010

Last Updated Date

March 4, 2010

Start Date ^ICMJE

May 2009

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC [ Time Frame: postoperative 24 hours, 48hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy

Brief Summary

The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Ureteroneocystostomy

Intervention ^ICMJE

Drug: ketorolac, fentanyl

intravenous PCA

Study Arm (s)

Experimental: ketorolac
Intervention: Drug: ketorolac, fentanyl
Experimental: fentanyl
Intervention: Drug: ketorolac, fentanyl

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Months to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01081535

Other Study ID Numbers ^ICMJE

4-2009-0107

Has Data Monitoring Committee

Yes

Responsible Party

Kil Hae Keum/professor, Yonsei University, College of Medicine

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hae Keum Kil

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

Information Provided By

Yonsei University

Verification Date

January 2010

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

To Top