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

Anesthesia, Caudal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869036
• Other study ID #: 82/12
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2012
• Last updated: December 3, 2013
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Caudal

Intervention

Drug:
• caudal anesthesia
Standard caudal anesthesia (Marcaine 2mg/kg)
• 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)

Locations

Country	Name	City	State
Israel	The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University	Jerusalem,

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

Fernandes ML, Pires KC, Tibúrcio 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	Yes