NCT02037802

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 6, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

January 14, 2014

Last Update Submit

October 2, 2014

Conditions

Renal Failure

Keywords

caudalepiduralpediatricrenaltransplanthemodynamics

Outcome Measures

Primary Outcomes (1)

  • Intraoperative blood pressure

    measure systolic and diastolic blood pressure

    from the induction of anesthesia till end of surgery at half an hour intervals

Secondary Outcomes (5)

  • postoperative blood pressure

    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

Other Outcomes (1)

  • pain scoring system (objective behavioural pain score)

    from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative

Study Arms (2)

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

Device: B-Braun, Perifix® ONE Paed, GermanyDrug: PethidineDrug: PropofolDrug: BupivacaineDrug: Fentanyl

control group

SHAM COMPARATOR

30 patients didn't receive caudal epidural analgesia

Drug: PethidineDrug: PropofolDrug: Fentanyl

Interventions

B-Braun, Perifix® ONE Paed, GermanyDEVICE

caudal epidural catheterization bupivacaine fentanyl

caudal epidural catheterization group
PethidineDRUG

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

caudal epidural catheterization groupcontrol group
PropofolDRUG

fentanyl propofol atracurium besylate

caudal epidural catheterization groupcontrol group
BupivacaineDRUG
caudal epidural catheterization group
FentanylDRUG
caudal epidural catheterization groupcontrol group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years
  • end stage renal disease
  • no known allergy to bupivacaine
  • both sexes

You may not qualify if:

  • known allergy to bupivacaine
  • inflammation at caudal area
  • spinal cord deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 26493396DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

MeperidinePropofolBupivacaineFentanyl

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Sherif M Soaida, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 6, 2014

Record last verified: 2014-10

Locations

EG(1)