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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01081535
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 9.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ketorolac	Drug: ketorolac, fentanyl; intravenous PCA
Experimental: fentanyl	Drug: ketorolac, fentanyl; intravenous PCA

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Hae Keum Kil, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01081535
• Other Study ID Numbers: 4-2009-0107
• First Posted: Mar 5, 2010
• Last Update Posted: Mar 5, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy
• Additional relevant MeSH terms: Ketorolac; Fentanyl

Study Results

No Results Posted as of Mar 5, 2010