Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery

NCT01869036 | Completed Phase 4

• 1 other identifier: 82/12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Caudal

Keywords

Caudal; anesthesia; morphine; children

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Side-effects measuring

  during operation and within 1 post-op day

Study Arms (2)

caudal anesthesia

ACTIVE COMPARATOR

Drug: caudal anesthesia

caudal anesthesia supplemented with morphine

ACTIVE COMPARATOR

Drug: caudal anesthesia supplemented with morphine

Interventions

caudal anesthesia DRUG

Standard caudal anesthesia (Marcaine 2mg/kg)

Also known as: sacral epidural anesthesia

caudal anesthesia

caudal anesthesia supplemented with morphine DRUG

Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)

caudal anesthesia supplemented with morphine

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children who are scheduled for renal surgery from two months age to puberty
• operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy

You may not qualify if:

• malignancy

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University

Jerusalem, Israel

Location

Related Publications (4)

• 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.

  PMID: 8747562 BACKGROUND

• 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.

  PMID: 22159880 BACKGROUND

• 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.

  PMID: 20952427 BACKGROUND

• 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.

  PMID: 17933162 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Caudal; Morphine

Intervention Hierarchy (Ancestors)

Anesthesia, Epidural; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: June 5, 2013
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-11

Locations

IL (1)