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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Caudal
• Intervention / Treatment: Drug: caudal anesthesia; Drug: caudal anesthesia supplemented with morphine

Detailed Description

The kidney surgery is a significant part of surgical armamentarium in pediatric urology. The common operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy.

One of the main goals in the postoperative period is to provide a painless recovery following by early mobilization of the child and early discharge home. Caudal anesthesia has become a gold standard in the renal surgery providing painless postoperative period, allowing earlier child feeding and speedy recovery. However some researchers have pointed out that caudal anesthesia with supplemented with Marcaine may provide painless postoperative period only for a very limited period of time and required additional painkiller therapy during postoperative period. Caudal anesthesia supplemented with Morphine has demonstrated their benefits in children who undergo infraumbilical surgery.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: caudal anesthesia	Drug: caudal anesthesia; Standard caudal anesthesia (Marcaine 2mg/kg); Other Names: sacral epidural anesthesia
Active Comparator: caudal anesthesia supplemented with morphine	Drug: caudal anesthesia supplemented with morphine; Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side-effects measuring	Side-effects such as vomiting, itching, respiratory depression, hypotension, and bradycardia will be observed. Oral intake and discharge home will be recorded. Complications rate will be recorded and compared between two groups.	during operation and within 1 post-op day

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: anesthesia; children; morphine; Caudal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Morphine
• Other Study ID Numbers: 82/12