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Completed

NCT Number: NCT01869036

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

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.

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Key information

Conditions

Anesthesia, Caudal

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caudal anesthesia

Drug

Standard caudal anesthesia (Marcaine 2mg/kg)

Other names: sacral epidural 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)

Primary outcomes

  1. statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire

    Time frame: at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report)

    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.

Secondary outcomes

  1. Side-effects measuring

    Time frame: during operation and within 1 post-op day

    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.

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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