Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.

Conditions
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Renal Failure

Intervention / Treatment
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* Device: B-Braun, Perifix® ONE Paed, Germany
* Drug: Pethidine
* Drug: Propofol
* Drug: Bupivacaine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-12 years end stage renal disease no known allergy to bupivacaine both sexes Exclusion Criteria: known allergy to bupivacaine inflammation at caudal area spinal cord deformity

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: caudal epidural catheterization group<br>30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours | Device: B-Braun, Perifix® ONE Paed, Germany<br>* caudal epidural catheterization bupivacaine fentanyl<br>Drug: Pethidine<br>* pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia<br>Drug: Propofol<br>* fentanyl propofol atracurium besylate<br>Drug: Bupivacaine<br> <br> Drug: Fentanyl<br> <br> |
| Sham Comparator: control group<br>30 patients didn't receive caudal epidural analgesia | Drug: Pethidine<br>* pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia<br>Drug: Propofol<br>* fentanyl propofol atracurium besylate<br>Drug: Fentanyl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood pressure | measure systolic and diastolic blood pressure | from the induction of anesthesia till end of surgery at half an hour intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative blood pressure | record systolic and diastolic blood pressure every hour for the first 24 hours postoperative | from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours | 
| intraoperative central venous pressure |  | fromom the induction of anesthesia till end of surgery at half an hour intervals | 
| postoperative heart rate |  | from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours | 
| postoperative central venous pressure |  | from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours | 
| intraoperative heart rate |  | from the induction of anesthesia till end of surgery at half an hour intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal, epidural, pediatric, renal, transplant, hemodynamics