Renal FailureNCT02037802
Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery
A study testing B-Braun, Perifix® ONE Paed, Germany, Pethidine and Propofol in people with Renal Failure, run by Cairo University at 1 site in Egypt.
Trial summary
pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- B-Braun, Perifix® ONE Paed, Germany, Pethidine and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2014to Oct 2014
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-12 years
- end stage renal disease
- no known allergy to bupivacaine
- both sexes
Who cannot join
- known allergy to bupivacaine
- inflammation at caudal area
- spinal cord deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.
pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.
- Conditions
- Renal Failure
- Being tested
- B-Braun, Perifix® ONE Paed, Germany, Pethidine, Propofol, Bupivacaine, Fentanyl
- Keywords
- caudal, epidural, pediatric, renal, transplant, hemodynamics
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Braun, Perifix® ONE Paed, GermanyDevice
caudal epidural catheterization bupivacaine fentanyl
PethidineDrug
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
PropofolDrug
fentanyl propofol atracurium besylate
BupivacaineDrug
FentanylDrug
| Study group | Role | What they receive |
|---|---|---|
| caudal epidural catheterization group | Active comparator | 30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours Receives: Device: B-Braun, Perifix® ONE Paed, Germany; Drug: Pethidine; Drug: Propofol; Drug: Bupivacaine; Drug: Fentanyl |
| control group | Sham comparator | 30 patients didn't receive caudal epidural analgesia Receives: Drug: Pethidine; Drug: Propofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood pressure
measure systolic and diastolic blood pressure
Measured: from the induction of anesthesia till end of surgery at half an hour intervals
Secondary outcomes (5)
postoperative blood pressure
record systolic and diastolic blood pressure every hour for the first 24 hours postoperative
Measured: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative central venous pressure
Measured: fromom the induction of anesthesia till end of surgery at half an hour intervals
postoperative heart rate
Measured: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
postoperative central venous pressure
Measured: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative heart rate
Measured: from the induction of anesthesia till end of surgery at half an hour intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd el moneim Soaida, MD, Cairo University
- Investigators
- Sherif M Soaida, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037802
- Sponsor's protocol ID
- SMS2014-1
- Status last verified
- Oct 2014
- First submitted
- 14 Jan 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Soaida SM, ElSheemy MS, Shouman AM, Shoukry AI, Morsi HA, Salah DM, Fadel FI, Bazaraa HM. Caudal extradural catheterization in pediatric renal transplant and its effect on perioperative hemodynamics and pain scoring: a prospective randomized study. J Anesth. 2016 Feb;30(1):47-54. doi: 10.1007/s00540-015-2087-8. Epub 2015 Oct 22.
PubMed 26493396
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.
- ClinicalTrials.gov ID
- NCT02037802
- Acronym / sponsor ID
- SMS2014-1
- Conditions
- Renal Failure
- Keywords
- caudal, epidural, pediatric, renal, transplant, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Jan 2014 (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.
pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caudal epidural catheterization group | Active comparator | Device: B-Braun, Perifix® ONE Paed, Germany, Drug: Pethidine, Drug: Propofol, Drug: Bupivacaine, Drug: Fentanyl30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours |
| control group | Sham comparator | Drug: Pethidine, Drug: Propofol, Drug: Fentanyl30 patients didn't receive caudal epidural analgesia |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-12 years
- end stage renal disease
- no known allergy to bupivacaine
- both sexes
Key exclusion criteria (3 listed)
- known allergy to bupivacaine
- inflammation at caudal area
- spinal cord deformity
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 |
|---|---|---|
| B-Braun, Perifix® ONE Paed, Germanycaudal epidural catheterization bupivacaine fentanyl | Device | caudal epidural catheterization group |
| Pethidinepethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia | Drug | caudal epidural catheterization group, control group |
| Propofolfentanyl propofol atracurium besylate | Drug | caudal epidural catheterization group, control group |
| Bupivacaine | Drug | caudal epidural catheterization group |
| Fentanyl | Drug | caudal epidural catheterization group, control group |
Primary outcome
Intraoperative blood pressure
Time frame: from the induction of anesthesia till end of surgery at half an hour intervals
measure systolic and diastolic blood pressure
5 secondary outcomes
postoperative blood pressure
Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative central venous pressure
Time frame: fromom the induction of anesthesia till end of surgery at half an hour intervals
postoperative heart rate
Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
postoperative central venous pressure
Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative heart rate
Time frame: from the induction of anesthesia till end of surgery at half an hour intervals
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 6 Oct 2014.
- Derived from this study: PubMed 26493396Soaida SM, ElSheemy MS, Shouman AM, Shoukry AI, Morsi HA, Salah DM, Fadel FI, Bazaraa HM. Caudal extradural catheterization in pediatric renal transplant and its effect on perioperative hemodynamics and pain scoring: a prospective randomized study. J Anesth. 2016 Feb;30(1):47-54. doi: 10.1007/s00540-015-2087-8. Epub 2015 Oct 22.
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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.
Sherif M Soaida, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Braun, Perifix® ONE Paed, Germany, Pethidine and Propofol in people with Renal Failure, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 3 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 6 Oct 2014. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Intraoperative blood pressure (time frame: from the induction of anesthesia till end of surgery at half an hour intervals). 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 NCT02037802, which also lists 1 linked publication.
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 6 Oct 2014.