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

NCT ID: NCT02037802

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-10-31

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.

Detailed Description

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Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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caudal epidural catheterization group

30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours

Group Type ACTIVE_COMPARATOR

B-Braun, Perifix® ONE Paed, Germany

Intervention Type DEVICE

caudal epidural catheterization bupivacaine fentanyl

Pethidine

Intervention Type DRUG

pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia

Propofol

Intervention Type DRUG

fentanyl propofol atracurium besylate

Bupivacaine

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

control group

30 patients didn't receive caudal epidural analgesia

Group Type SHAM_COMPARATOR

Pethidine

Intervention Type DRUG

pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia

Propofol

Intervention Type DRUG

fentanyl propofol atracurium besylate

Fentanyl

Intervention Type DRUG

Interventions

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B-Braun, Perifix® ONE Paed, Germany

caudal epidural catheterization bupivacaine fentanyl

Intervention Type DEVICE

Pethidine

pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia

Intervention Type DRUG

Propofol

fentanyl propofol atracurium besylate

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Mohamed Abd el moneim Soaida, MD

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherif M Soaida, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 26493396 (View on PubMed)

Other Identifiers

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SMS2014-1

Identifier Type: -

Identifier Source: org_study_id

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