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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037802
• Other study ID #: SMS2014-1
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: October 2, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt:Cairo university
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Failure

Intervention

Device:
• B-Braun, Perifix® ONE Paed, Germany
caudal epidural catheterization bupivacaine fentanyl

Drug:
• Pethidine
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
• Propofol
fentanyl propofol atracurium besylate
• Bupivacaine

• Fentanyl

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pain scoring system (objective behavioural pain score)		from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative	No
Primary	Intraoperative blood pressure	measure systolic and diastolic blood pressure	from the induction of anesthesia till end of surgery at half an hour intervals	No
Secondary	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	No
Secondary	intraoperative central venous pressure		fromom the induction of anesthesia till end of surgery at half an hour intervals	No
Secondary	postoperative heart rate		from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours	No
Secondary	postoperative central venous pressure		from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours	No
Secondary	intraoperative heart rate		from the induction of anesthesia till end of surgery at half an hour intervals	No