Anesthesia, CaudalPhase 4NCT01869036
Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery
A Phase 4 study testing caudal anesthesia and caudal anesthesia supplemented with morphine in people with Anesthesia, Caudal, run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Anesthesia, Caudal
- What is being tested?
- caudal anesthesia and caudal anesthesia supplemented with morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
Jerusalem
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Caudal
- Being tested
- caudal anesthesia, caudal anesthesia supplemented with morphine
- Keywords
- Caudal, anesthesia, morphine, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal anesthesiaDrug
Also called sacral epidural anesthesia
Standard caudal anesthesia (Marcaine 2mg/kg)
caudal anesthesia supplemented with morphineDrug
Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)
| Study group | Role | What they receive |
|---|---|---|
| caudal anesthesia | Active comparator | Not described Receives: Drug: caudal anesthesia |
| caudal anesthesia supplemented with morphine | Active comparator | Not described Receives: Drug: caudal anesthesia supplemented with morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report)
Secondary outcomes (1)
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.
Measured: during operation and within 1 post-op day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, CaudalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Chertin, MD, Principal investigator, Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869036
- Sponsor's protocol ID
- 82/12
- Status last verified
- Nov 2013
- First submitted
- 7 Aug 2012
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 8747562Fernandes 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.
PubMed 22159880Singh 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.
PubMed 20952427Cesur 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.
PubMed 17933162
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery - Prospective Study
- ClinicalTrials.gov ID
- NCT01869036
- Acronym / sponsor ID
- 82/12
- Conditions
- Anesthesia, Caudal
- Keywords
- Caudal, anesthesia, morphine, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caudal anesthesia | Active comparator | Drug: caudal anesthesia |
| caudal anesthesia supplemented with morphine | Active comparator | Drug: caudal anesthesia supplemented with morphine |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caudal anesthesiaAlso: sacral epidural anesthesiaStandard caudal anesthesia (Marcaine 2mg/kg) | Drug | caudal anesthesia |
| caudal anesthesia supplemented with morphineCaudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg) | Drug | caudal anesthesia supplemented with morphine |
Primary outcome
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.
1 secondary outcome
Side-effects measuring
Time frame: during operation and within 1 post-op day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Background: PubMed 8747562Mayhew 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.
- Background: PubMed 22159880Fernandes 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.
- Background: PubMed 20952427Singh 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.
- Background: PubMed 17933162Cesur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Chertin, MD principal investigator
Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing caudal anesthesia and caudal anesthesia supplemented with morphine in people with Anesthesia, Caudal, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869036, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.