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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

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ClinicalTrials.gov Identifier: NCT01081535
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : March 5, 2010
Sponsor:
Information provided by:
Yonsei University

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

Condition or disease Intervention/treatment Phase
Ureteroneocystostomy Drug: ketorolac, fentanyl Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ketorolac Drug: ketorolac, fentanyl
intravenous PCA
Experimental: fentanyl Drug: ketorolac, fentanyl
intravenous PCA



Primary Outcome Measures :
  1. Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC [ Time Frame: postoperative 24 hours, 48hours ]


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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: January 2010

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

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