NCT01869036|CompletedPhase 4
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Sponsor study identifier
interventional
40
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
November 2013
Actual (reported)The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal anesthesia in children who undergo renal surgery in our department.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 7, 2012
Actual (reported)June 5, 2013
Actual (reported)October 2013
Actual (reported)November 2013
Actual (reported)statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire
The following parameters will be compared between two groups: the length of surgery, intraoperative and postoperative narcotic requirements. The children parents or children thyself will be asked to fill out the pain assessment questionnaire.
at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report)
Side-effects measuring
during operation and within 1 post-op day
Standard caudal anesthesia (Marcaine 2mg/kg)
Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)
The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
Jerusalem, Israel
Mayhew JF, Brodsky RC, Blakey D, Petersen W. Low-dose caudal morphine for postoperative analgesia in infants and children: a report of 500 cases. J Clin Anesth. 1995 Dec;7(8):640-2. doi: 10.1016/0952-8180(95)00089-5.
Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
Boris Chertin, MD
Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
40 participants (actual enrollment reported by the registry).
First Submitted
August 7, 2012
First Posted
June 5, 2013
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography
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Singh R, Kumar N, Singh P. Randomized controlled trial comparing morphine or clonidine with bupivacaine for caudal analgesia in children undergoing upper abdominal surgery. Br J Anaesth. 2011 Jan;106(1):96-100. doi: 10.1093/bja/aeq274. Epub 2010 Oct 14.
Cesur M, Alici HA, Erdem AF, Yapanoglu T, Silbir F. Effects of reduction of the caudal morphine dose in paediatric circumcision on quality of postoperative analgesia and morphine-related side-effects. Anaesth Intensive Care. 2007 Oct;35(5):743-7. doi: 10.1177/0310057X0703500514.
Primary Completion
October 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
December 4, 2013
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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