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

NCT ID: NCT01869036

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia, Caudal

Keywords

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Caudal anesthesia morphine children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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caudal anesthesia

Group Type ACTIVE_COMPARATOR

caudal anesthesia

Intervention Type DRUG

Standard caudal anesthesia (Marcaine 2mg/kg)

caudal anesthesia supplemented with morphine

Group Type ACTIVE_COMPARATOR

caudal anesthesia supplemented with morphine

Intervention Type 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)

Interventions

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caudal anesthesia

Standard caudal anesthesia (Marcaine 2mg/kg)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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sacral epidural anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris Chertin, MD

Role: PRINCIPAL_INVESTIGATOR

Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel

Locations

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

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 8747562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22159880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20952427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17933162 (View on PubMed)

Other Identifiers

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82/12

Identifier Type: -

Identifier Source: org_study_id