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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:
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
  Purpose

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


Condition Intervention
Ureteroneocystostomy
Drug: ketorolac, fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ketorolac Drug: ketorolac, fentanyl
intravenous PCA
Experimental: fentanyl Drug: ketorolac, fentanyl
intravenous PCA

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081535

Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hae Keum Kil Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Kil Hae Keum/professor, Yonsei University, College of Medicine
ClinicalTrials.gov Identifier: NCT01081535     History of Changes
Other Study ID Numbers: 4-2009-0107
Study First Received: March 4, 2010
Last Updated: March 4, 2010
Health Authority: Korea: Korea Food and Drug Administration
Korea: Ministry for Health and Welfare

Keywords provided by Yonsei University:
Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy

Additional relevant MeSH terms:
Fentanyl
Ketorolac
Ketorolac Tromethamine
Adjuvants, Anesthesia
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014