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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:

U.S. FDA Resources

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
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, Welfare and Family Affairs

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

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

ClinicalTrials.gov processed this record on May 19, 2013